Nicotine Dependence, Nicotine Withdrawal
Conditions
Keywords
Nicotine, Smoking
Brief summary
Male and female smokers were recruited to undergo 2 phases of smoking cessation. Each phase was 4 days long and involved 3 brain-imaging scans, blood draws and an intervention involving progesterone or a matched placebo.
Detailed description
The purpose of this study is to learn whether a sex hormone called progesterone is helpful in reducing cigarette smoking and craving for cigarettes. This study also includes brain imaging to measure possible effects of progesterone on certain neurochemicals. These neurochemicals are called gamma-aminobutyric acid (or GABA for short) and glutamate. Both nicotine and progesterone affect these brain chemicals. Individuals wishing to participate in this study must be medically healthy men or women who smoke at least 10 cigarettes per day or greater. Participants must not suffer from a mental illness or use drugs other than nicotine and marijuana. Participants cannot have any implanted metallic devices such as pacemakers, orthodontic braces, or shrapnel. Participants must not have peanut allergies and must never have had a reaction to progesterone. Finally, participants cannot be taking any medications for anxiety, depression or insomnia.
Interventions
DRUGProgesterone
Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone.
DRUGPlacebo
Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo.
Sponsors
National Institute on Drug Abuse (NIDA)
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Female and male smokers, aged 18 to 50 years; * History of smoking greater than or equal to 10 cigarettes daily for the past year, as per self-report (periods of smoking abstinence within the last year will be exclusionary at PI discretion); * Not seeking treatment at the time of the study for nicotine dependence; * Have a Fagerstrom Test for Nicotine Dependence (FTND) score of at least 3 and a Carbon Monoxide (CO) level greater than or equal to 11 ppm; * Clean urine drug screen (marijuana is permissible); * In good health as verified by medical history; * For women, not pregnant as determined by pregnancy screening, nor breast feeding.
Exclusion criteria
* History of major medical illness: including liver diseases, abnormal vaginal bleeding, suspected or known malignancy; thrombophlebitis; deep vein thrombosis; pulmonary embolus; clotting or bleeding disorders; heart disease; diabetes; history of stroke or other medical conditions that the physician investigator deems as contraindicated for the patient to be in the study; * Regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics) and recent (within previous year) psychiatric diagnosis and treatment for Axis I disorders including major depression, bipolar affective disorder, generalized anxiety disorder, post-traumatic stress disorder and panic disorder; * Lifetime history of schizophrenia or other psychotic disorder; * Lifetime substance dependence disorder, excepting nicotine, alcohol and marijuana, as per SCID interview * Substance use disorders within the previous 2 years, excepting nicotine, as per SCID interview * Regular use of any other tobacco products than cigarettes, including smokeless tobacco and nicotine products; * Known allergy to progesterone or peanuts (vehicle for micronized progesterone).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| GABA Pre and Post Progesterone Administration (Dorsal Anterior Cingulate Cortex [DACC]) | Test Day #2 and Test Day #5 - 6 total scans over the period of 2-3 months. | GABA concentrations (collected in the Dorsal Anterior Cingulate Cortex \[DACC\]) will be obtained using the non-invasive neuroimaging method of proton magnetic resonance spectroscopy (1H-MRS) both before and after placebo administration and smoking abstinence. In total subjects will undergo 6 1H-MRS scans. The 6 1H-MRS scans take place over a period of approximately 1-2 months. Each paradigm (placebo/progesterone) takes approximately one week, with an approximately two-week wash in between paradigms for men and an approximately 1-month wash in between paradigms for women. The subject will undergo a smoking session on Test Day #1 and Test Day #5, MRS scans are conducted on Test Day #2 (2 scans) and Test Day #5 (1 scan). Minimal data is available for the primary outcome due to substantial issues with the 7T scanner. All subsequent scans were conducted on a 3T scanner which does not have the capacity to collect data on GABA. |
| GABA Pre and Post Progesterone Administration (Dorsolateral Pre-Frontal Cortex [DLPFC]) | Test Day #2 and Test Day #5 - 6 total scans over the period of 2-3 months. | GABA concentrations (collected in the Dorsolateral Pre-Frontal Cortex \[DLPFC\]) will be obtained using the non-invasive neuroimaging method of proton magnetic resonance spectroscopy (1H-MRS) both before and after placebo administration and smoking abstinence. In total subjects will undergo 6 1H-MRS scans. The 6 1H-MRS scans take place over a period of approximately 1-2 months. Each paradigm (placebo/progesterone) takes approximately one week, with an approximately two-week wash in between paradigms for men and an approximately 1-month wash in between paradigms for women. The subject will undergo a smoking session on Test Day #1 and Test Day #5, MRS scans are conducted on Test Day #2 (2 scans) and Test Day #5 (1 scan). Minimal data is available for the primary outcome due to substantial issues with the 7T scanner. All subsequent scans were conducted on a 3T scanner which does not have the capacity to collect data on GABA. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Brief Questionnaire on Smoking Urges (BQSU) | Day 1 (pre and post smoking session, day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session) | Craving will be assessed using the Brief Questionnaire on Smoking Urges (BQSU). It ranges from 7-70 with higher levels indicating higher levels of nicotine craving. |
| Tiffany Questionnaire on Smoking Urges (TQSU) | Day 1 (pre smoking session, day 3 (PM), day 4 (PM), day 5 (pre smoking session) | Craving will also be assessed using the Tiffany Questionnaire for Smoking Urges. It ranges from 32 to 224 with higher scores indicated higher levels of smoking urges/craving. |
| Profile of Mood States (POMS) Subscale: Tension-Anxiety | Day 2 (pre and post scan), Day 5 (pre smoking session) | Profile of Mood States (POMS) Subscale: Tension-Anxiety. This subscale ranges from 0-28 with higher levels indicating greater tension/anxiety. |
| Profile of Mood States (POMS) Subscale: Depression-Dejection | Day 2 (pre and post scan), Day 5 (pre smoking session) | Profile of Mood States (POMS) Subscale: Depression-Dejection. This subscale ranges from 0-60 with higher levels indicating greater depression/dejection. |
| Profile of Mood States (POMS) Subscale: Anger-Hostility | Day 2 (pre and post scan), Day 5 (pre smoking session) | Profile of Mood States (POMS) Subscale: Anger-Hostility. This scale ranges from 0 to 48 with higher levels indicating higher levels of anger/hostility. |
| Profile of Mood States (POMS) Subscale: Fatigue | Day 2 (pre and post scan), Day 5 (pre smoking session) | Profile of Mood States (POMS) Subscale: Fatigue. This subscale ranges from 0 to 28 with higher scores indicating higher levels of fatigue. |
| Profile of Mood State (POMS) Subscale: Vigor | Day 2 (pre and post scan), Day 5 (pre smoking session) | Profile of Mood State (POMS) Subscale: Vigor. Subscale ranges from 0 to 32, with higher levels indicating higher levels of vigor. |
| Profile of Mood States (POMS) Subscale: Confusion-Bewilderment | Day 2 (pre and post scan), Day 5 (pre smoking session) | Profile of Mood States (POMS) Subscale: Confusion-Bewilderment. Ranges from 0 to 28 with higher levels indicating higher levels of confusion/bewilderment. |
| Visual Analog Scale (VAS) Question: Headache | Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session) | Visual Analog Scale (VAS) question: Headache. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling. |
| Visual Analog Scale (VAS) Question: Hunger | Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session) | Visual Analog Scale (VAS) question: Hunger. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling. |
| Visual Analog Scale (VAS) Question: Nauseous | Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session) | Visual Analog Scale (VAS) question: Nauseous. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling. |
| Visual Analog Scale (VAS) Question: Heartburn. | Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session) | Visual Analog Scale (VAS) question: Heartburn. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling. |
| Visual Analog Scale (VAS) Question: Tired | Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session) | Visual Analog Scale (VAS) question: Tired. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling. |
| Visual Analog Scale (VAS) Question: Irritable | Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session) | Visual Analog Scale (VAS) question: Irritable. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling. |
| Visual Analog Scale (VAS) Question: Nervous | Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session) | Visual Analog Scale (VAS) question: Nervous. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling. |
| Visual Analog Scale (VAS) Question: Relaxed | Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session) | Visual Analog Scale (VAS) question: Relaxed. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling. |
| Visual Analog Scale (VAS) Question: Talkative | Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session) | Visual Analog Scale (VAS) question: Headache. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling. |
| Visual Analog Scale (VAS) Question: Happy | Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session) | Visual Analog Scale (VAS) question: Happy. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling. |
| Visual Analog Scale (VAS) Question: Sad | Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session) | Visual Analog Scale (VAS) question: Sad. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling. |
| Visual Analog Scale (VAS) Question: Calm | Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session) | Visual Analog Scale (VAS) question: Calm. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling. |
| Visual Analog Scale (VAS) Question: Depressed | Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session) | Visual Analog Scale (VAS) question: Depressed. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling. |
| Visual Analog Scale (VAS) Question: Drowsy | Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session) | Visual Analog Scale (VAS) question: Drowsy. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling. |
| Visual Analog Scale (VAS) Question: Anxious | Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session) | Visual Analog Scale (VAS) question: Anxious. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling. |
| Positive and Negative Affect Schedule (PANAS) Negative Affect | Day 1 (pre and post smoking session, day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session) | Positive and Negative Affect Schedule (PANAS) Negative Affect Score. Ranges from 10-50 with higher scores representing higher levels of negative affect. |
| Positive and Negative Affect Schedule (PANAS) Positive Affect | Day 1 (pre and post smoking session, day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session) | Positive and Negative Affect Schedule (PANAS) Positive Affect Score. Ranges from 10-50 with higher scores representing higher levels of positive affect. |
| Nicotine Effects Questionnaire (NEQ) Question: Feels Strength of Nicotine | Day 1 (pre smoking session), Day 5 (post smoking session) | Nicotine Effects Questionnaire (NEQ) question: feels strength of nicotine. Score ranges from 0 to 100 with higher levels indicating feeling stronger effects of nicotine after smoking. |
| Nicotine Effects Questionnaire (NEQ) Question: Feels Good Effects of Nicotine | Day 1 (pre smoking session), Day 5 (post smoking session) | NEQ question: feels good effects of nicotine. Score ranges from 0 to 100 with higher levels indicating feeling more good effects of nicotine after smoking. |
| Nicotine Effects Questionnaire (NEQ) Question: Feels Bad Effects of Nicotine | Day 1 (pre smoking session), Day 5 (post smoking session) | Nicotine Effects Questionnaire (NEQ) question: feels bad effects of nicotine. Score ranges from 0 to 100 with higher levels indicating feeling more bad effects of nicotine after smoking. |
| Nicotine Effects Questionnaire (NEQ) Question: Head Rush | Day 1 (pre smoking session), Day 5 (post smoking session) | Nicotine Effects Questionnaire (NEQ) question: feels head rush. Score ranges from 0 to 100 with higher levels indicating feeling stronger/more intense head rush after smoking. |
| Visual Analog Scale (VAS) Question: Energetic | Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session) | Visual Analog Scale (VAS) question: Energetic. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling. |
| Symptoms During Nicotine Abstinence (NWSC) | Day 1 (pre and post smoking session, day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session) | Withdrawal symptoms will be measured using the Nicotine Withdrawal Symptoms Checklist (NWSC). The scale ranges from a minimum of 0 to a maximum of 28, with higher scores indicating greater withdrawal (more withdrawal symptoms, higher intensity/severity of withdrawal). |
Countries
United States
Participant flow
Pre-assignment details
There were 81 participants who were enrolled in the study, but N = 15 were lost to early follow-up before they could be randomized. Therefore, only N = 66 participants were randomized (N = 34 randomized to receive placebo first, N = 32 randomized to receive progesterone first).
Participants by arm
| Arm | Count |
|---|---|
| Placebo First, Progesterone Second This group was randomized to receive placebo during phase 1 of the crossover trial and progesterone during phase 2 of the crossover trial. | 34 |
| Progesterone First, Placebo Second This group was randomized to receive progesterone during phase 1 of the crossover trial and placebo during phase 2 of the crossover trial. | 32 |
| Total | 66 |
Baseline characteristics
| Characteristic | Progesterone First, Placebo Second | Total | Placebo First, Progesterone Second |
|---|---|---|---|
| Age, Continuous | 37.7 years STANDARD_DEVIATION 7.6 | 36.6 years STANDARD_DEVIATION 8.4 | 35.5 years STANDARD_DEVIATION 9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 5 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants | 58 Participants | 31 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 22 Participants | 44 Participants | 22 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 8 Participants | 4 Participants |
| Race (NIH/OMB) White | 5 Participants | 13 Participants | 8 Participants |
| Sex: Female, Male Female | 17 Participants | 33 Participants | 16 Participants |
| Sex: Female, Male Male | 15 Participants | 33 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 66 | 0 / 66 |
| other Total, other adverse events | 54 / 66 | 56 / 66 |
| serious Total, serious adverse events | 0 / 66 | 0 / 66 |
Outcome results
Primary
GABA Pre and Post Progesterone Administration (Dorsal Anterior Cingulate Cortex [DACC])
GABA concentrations (collected in the Dorsal Anterior Cingulate Cortex \[DACC\]) will be obtained using the non-invasive neuroimaging method of proton magnetic resonance spectroscopy (1H-MRS) both before and after placebo administration and smoking abstinence. In total subjects will undergo 6 1H-MRS scans. The 6 1H-MRS scans take place over a period of approximately 1-2 months. Each paradigm (placebo/progesterone) takes approximately one week, with an approximately two-week wash in between paradigms for men and an approximately 1-month wash in between paradigms for women. The subject will undergo a smoking session on Test Day #1 and Test Day #5, MRS scans are conducted on Test Day #2 (2 scans) and Test Day #5 (1 scan). Minimal data is available for the primary outcome due to substantial issues with the 7T scanner. All subsequent scans were conducted on a 3T scanner which does not have the capacity to collect data on GABA.
Time frame: Test Day #2 and Test Day #5 - 6 total scans over the period of 2-3 months.
Population: Some values were missing due to visits for these individuals scheduled after there were issues with the 7T scanner, so data could not be collected for other participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Progesterone 200 mg Capsules | GABA Pre and Post Progesterone Administration (Dorsal Anterior Cingulate Cortex [DACC]) | Test day 2 (baseline, pre-scan) | 1.23 mg/dl | Standard Error 0.05 |
| Progesterone 200 mg Capsules | GABA Pre and Post Progesterone Administration (Dorsal Anterior Cingulate Cortex [DACC]) | Test day 2 (post-scan) | 1.28 mg/dl | Standard Error 0.05 |
| Progesterone 200 mg Capsules | GABA Pre and Post Progesterone Administration (Dorsal Anterior Cingulate Cortex [DACC]) | Test day 5 (pre-smoking) | 1.21 mg/dl | Standard Error 0.05 |
| Progesterone 200 mg Look-alike Capsules | GABA Pre and Post Progesterone Administration (Dorsal Anterior Cingulate Cortex [DACC]) | Test day 2 (baseline, pre-scan) | 1.17 mg/dl | Standard Error 0.04 |
| Progesterone 200 mg Look-alike Capsules | GABA Pre and Post Progesterone Administration (Dorsal Anterior Cingulate Cortex [DACC]) | Test day 2 (post-scan) | 1.24 mg/dl | Standard Error 0.04 |
| Progesterone 200 mg Look-alike Capsules | GABA Pre and Post Progesterone Administration (Dorsal Anterior Cingulate Cortex [DACC]) | Test day 5 (pre-smoking) | 1.17 mg/dl | Standard Error 0.05 |
Primary
GABA Pre and Post Progesterone Administration (Dorsolateral Pre-Frontal Cortex [DLPFC])
GABA concentrations (collected in the Dorsolateral Pre-Frontal Cortex \[DLPFC\]) will be obtained using the non-invasive neuroimaging method of proton magnetic resonance spectroscopy (1H-MRS) both before and after placebo administration and smoking abstinence. In total subjects will undergo 6 1H-MRS scans. The 6 1H-MRS scans take place over a period of approximately 1-2 months. Each paradigm (placebo/progesterone) takes approximately one week, with an approximately two-week wash in between paradigms for men and an approximately 1-month wash in between paradigms for women. The subject will undergo a smoking session on Test Day #1 and Test Day #5, MRS scans are conducted on Test Day #2 (2 scans) and Test Day #5 (1 scan). Minimal data is available for the primary outcome due to substantial issues with the 7T scanner. All subsequent scans were conducted on a 3T scanner which does not have the capacity to collect data on GABA.
Time frame: Test Day #2 and Test Day #5 - 6 total scans over the period of 2-3 months.
Population: Some data was not collected for participants due to issues with the 7T.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Progesterone 200 mg Capsules | GABA Pre and Post Progesterone Administration (Dorsolateral Pre-Frontal Cortex [DLPFC]) | Day 2- post scan | 1.05 mg/dl | Standard Error 0.13 |
| Progesterone 200 mg Capsules | GABA Pre and Post Progesterone Administration (Dorsolateral Pre-Frontal Cortex [DLPFC]) | Day 2- pre scan | 1.18 mg/dl | Standard Error 0.13 |
| Progesterone 200 mg Capsules | GABA Pre and Post Progesterone Administration (Dorsolateral Pre-Frontal Cortex [DLPFC]) | Day 5- after scan, pre smoking | 1.06 mg/dl | Standard Error 0.11 |
| Progesterone 200 mg Look-alike Capsules | GABA Pre and Post Progesterone Administration (Dorsolateral Pre-Frontal Cortex [DLPFC]) | Day 2- pre scan | 1.20 mg/dl | Standard Error 0.11 |
| Progesterone 200 mg Look-alike Capsules | GABA Pre and Post Progesterone Administration (Dorsolateral Pre-Frontal Cortex [DLPFC]) | Day 2- post scan | 0.98 mg/dl | Standard Error 0.12 |
| Progesterone 200 mg Look-alike Capsules | GABA Pre and Post Progesterone Administration (Dorsolateral Pre-Frontal Cortex [DLPFC]) | Day 5- after scan, pre smoking | 1.11 mg/dl | Standard Error 0.16 |
Secondary
Brief Questionnaire on Smoking Urges (BQSU)
Craving will be assessed using the Brief Questionnaire on Smoking Urges (BQSU). It ranges from 7-70 with higher levels indicating higher levels of nicotine craving.
Time frame: Day 1 (pre and post smoking session, day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)
Population: Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Progesterone 200 mg Capsules | Brief Questionnaire on Smoking Urges (BQSU) | Day 2; pre-1st scan | 38.47 score on a scale | Standard Error 2.28 |
| Progesterone 200 mg Capsules | Brief Questionnaire on Smoking Urges (BQSU) | Day 5; after smoking | 27.64 score on a scale | Standard Error 2.29 |
| Progesterone 200 mg Capsules | Brief Questionnaire on Smoking Urges (BQSU) | Day 1; pre-1st smoking session | 40.89 score on a scale | Standard Error 2.23 |
| Progesterone 200 mg Capsules | Brief Questionnaire on Smoking Urges (BQSU) | Day 3; abstinence AM | 41.91 score on a scale | Standard Error 2.28 |
| Progesterone 200 mg Capsules | Brief Questionnaire on Smoking Urges (BQSU) | Day 2; post-2nd scan | 38.81 score on a scale | Standard Error 2.31 |
| Progesterone 200 mg Capsules | Brief Questionnaire on Smoking Urges (BQSU) | Day 4; abstinence AM | 40.90 score on a scale | Standard Error 2.3 |
| Progesterone 200 mg Capsules | Brief Questionnaire on Smoking Urges (BQSU) | Day 3; abstinence PM | 40.84 score on a scale | Standard Error 2.28 |
| Progesterone 200 mg Capsules | Brief Questionnaire on Smoking Urges (BQSU) | Day 4; abstinence PM | 39.23 score on a scale | Standard Error 2.28 |
| Progesterone 200 mg Capsules | Brief Questionnaire on Smoking Urges (BQSU) | Day 5; after scan, pre-smoking | 41.95 score on a scale | Standard Error 2.26 |
| Progesterone 200 mg Capsules | Brief Questionnaire on Smoking Urges (BQSU) | Day 1; post-1st smoking session | 30.45 score on a scale | Standard Error 2.33 |
| Progesterone 200 mg Look-alike Capsules | Brief Questionnaire on Smoking Urges (BQSU) | Day 5; after smoking | 28.22 score on a scale | Standard Error 2.42 |
| Progesterone 200 mg Look-alike Capsules | Brief Questionnaire on Smoking Urges (BQSU) | Day 1; post-1st smoking session | 25.77 score on a scale | Standard Error 2.22 |
| Progesterone 200 mg Look-alike Capsules | Brief Questionnaire on Smoking Urges (BQSU) | Day 2; pre-1st scan | 34.34 score on a scale | Standard Error 2.19 |
| Progesterone 200 mg Look-alike Capsules | Brief Questionnaire on Smoking Urges (BQSU) | Day 2; post-2nd scan | 37.98 score on a scale | Standard Error 2.26 |
| Progesterone 200 mg Look-alike Capsules | Brief Questionnaire on Smoking Urges (BQSU) | Day 3; abstinence AM | 41.82 score on a scale | Standard Error 2.26 |
| Progesterone 200 mg Look-alike Capsules | Brief Questionnaire on Smoking Urges (BQSU) | Day 5; after scan, pre-smoking | 42.38 score on a scale | Standard Error 2.35 |
| Progesterone 200 mg Look-alike Capsules | Brief Questionnaire on Smoking Urges (BQSU) | Day 1; pre-1st smoking session | 41.94 score on a scale | Standard Error 2.16 |
| Progesterone 200 mg Look-alike Capsules | Brief Questionnaire on Smoking Urges (BQSU) | Day 3; abstinence PM | 42.03 score on a scale | Standard Error 2.25 |
| Progesterone 200 mg Look-alike Capsules | Brief Questionnaire on Smoking Urges (BQSU) | Day 4; abstinence AM | 40.29 score on a scale | Standard Error 2.26 |
| Progesterone 200 mg Look-alike Capsules | Brief Questionnaire on Smoking Urges (BQSU) | Day 4; abstinence PM | 37.68 score on a scale | Standard Error 2.3 |
Secondary
Nicotine Effects Questionnaire (NEQ) Question: Feels Bad Effects of Nicotine
Nicotine Effects Questionnaire (NEQ) question: feels bad effects of nicotine. Score ranges from 0 to 100 with higher levels indicating feeling more bad effects of nicotine after smoking.
Time frame: Day 1 (pre smoking session), Day 5 (post smoking session)
Population: Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Progesterone 200 mg Capsules | Nicotine Effects Questionnaire (NEQ) Question: Feels Bad Effects of Nicotine | Day 1; pre-1st smoking session | 26.25 score on a scale | Standard Error 3.91 |
| Progesterone 200 mg Capsules | Nicotine Effects Questionnaire (NEQ) Question: Feels Bad Effects of Nicotine | Day 5; after smoking | 25.39 score on a scale | Standard Error 3.96 |
| Progesterone 200 mg Look-alike Capsules | Nicotine Effects Questionnaire (NEQ) Question: Feels Bad Effects of Nicotine | Day 1; pre-1st smoking session | 25.92 score on a scale | Standard Error 3.86 |
| Progesterone 200 mg Look-alike Capsules | Nicotine Effects Questionnaire (NEQ) Question: Feels Bad Effects of Nicotine | Day 5; after smoking | 28.70 score on a scale | Standard Error 4.19 |
Secondary
Nicotine Effects Questionnaire (NEQ) Question: Feels Good Effects of Nicotine
NEQ question: feels good effects of nicotine. Score ranges from 0 to 100 with higher levels indicating feeling more good effects of nicotine after smoking.
Time frame: Day 1 (pre smoking session), Day 5 (post smoking session)
Population: Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Progesterone 200 mg Capsules | Nicotine Effects Questionnaire (NEQ) Question: Feels Good Effects of Nicotine | Day 1; pre-1st smoking session | 67.72 score on a scale | Standard Error 3.75 |
| Progesterone 200 mg Capsules | Nicotine Effects Questionnaire (NEQ) Question: Feels Good Effects of Nicotine | Day 5; after smoking | 67.84 score on a scale | Standard Error 3.8 |
| Progesterone 200 mg Look-alike Capsules | Nicotine Effects Questionnaire (NEQ) Question: Feels Good Effects of Nicotine | Day 1; pre-1st smoking session | 67.84 score on a scale | Standard Error 3.71 |
| Progesterone 200 mg Look-alike Capsules | Nicotine Effects Questionnaire (NEQ) Question: Feels Good Effects of Nicotine | Day 5; after smoking | 64.72 score on a scale | Standard Error 3.99 |
Secondary
Nicotine Effects Questionnaire (NEQ) Question: Feels Strength of Nicotine
Nicotine Effects Questionnaire (NEQ) question: feels strength of nicotine. Score ranges from 0 to 100 with higher levels indicating feeling stronger effects of nicotine after smoking.
Time frame: Day 1 (pre smoking session), Day 5 (post smoking session)
Population: Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Progesterone 200 mg Capsules | Nicotine Effects Questionnaire (NEQ) Question: Feels Strength of Nicotine | Day 1; pre-1st smoking session | 71.45 score on a scale | Standard Error 3.55 |
| Progesterone 200 mg Capsules | Nicotine Effects Questionnaire (NEQ) Question: Feels Strength of Nicotine | Day 5; after smoking | 74.87 score on a scale | Standard Error 3.6 |
| Progesterone 200 mg Look-alike Capsules | Nicotine Effects Questionnaire (NEQ) Question: Feels Strength of Nicotine | Day 1; pre-1st smoking session | 71.01 score on a scale | Standard Error 3.51 |
| Progesterone 200 mg Look-alike Capsules | Nicotine Effects Questionnaire (NEQ) Question: Feels Strength of Nicotine | Day 5; after smoking | 75.25 score on a scale | Standard Error 3.79 |
Secondary
Nicotine Effects Questionnaire (NEQ) Question: Head Rush
Nicotine Effects Questionnaire (NEQ) question: feels head rush. Score ranges from 0 to 100 with higher levels indicating feeling stronger/more intense head rush after smoking.
Time frame: Day 1 (pre smoking session), Day 5 (post smoking session)
Population: Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Progesterone 200 mg Capsules | Nicotine Effects Questionnaire (NEQ) Question: Head Rush | Day 1; pre-1st smoking session | 30.58 score on a scale | Standard Error 4.65 |
| Progesterone 200 mg Capsules | Nicotine Effects Questionnaire (NEQ) Question: Head Rush | Day 5; after smoking | 40.23 score on a scale | Standard Error 4.71 |
| Progesterone 200 mg Look-alike Capsules | Nicotine Effects Questionnaire (NEQ) Question: Head Rush | Day 1; pre-1st smoking session | 29.38 score on a scale | Standard Error 4.59 |
| Progesterone 200 mg Look-alike Capsules | Nicotine Effects Questionnaire (NEQ) Question: Head Rush | Day 5; after smoking | 42.48 score on a scale | Standard Error 5.01 |
Secondary
Positive and Negative Affect Schedule (PANAS) Negative Affect
Positive and Negative Affect Schedule (PANAS) Negative Affect Score. Ranges from 10-50 with higher scores representing higher levels of negative affect.
Time frame: Day 1 (pre and post smoking session, day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)
Population: Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Progesterone 200 mg Capsules | Positive and Negative Affect Schedule (PANAS) Negative Affect | Day 1; pre-1st smoking session | 11.94 score on a scale | Standard Error 0.45 |
| Progesterone 200 mg Capsules | Positive and Negative Affect Schedule (PANAS) Negative Affect | Day 1; post-1st smoking session | 10.64 score on a scale | Standard Error 0.46 |
| Progesterone 200 mg Capsules | Positive and Negative Affect Schedule (PANAS) Negative Affect | Day 2; pre-1st scan | 11.25 score on a scale | Standard Error 0.45 |
| Progesterone 200 mg Capsules | Positive and Negative Affect Schedule (PANAS) Negative Affect | Day 2; post-2nd scan | 11.59 score on a scale | Standard Error 0.46 |
| Progesterone 200 mg Capsules | Positive and Negative Affect Schedule (PANAS) Negative Affect | Day 3; abstinence AM | 12.31 score on a scale | Standard Error 0.46 |
| Progesterone 200 mg Capsules | Positive and Negative Affect Schedule (PANAS) Negative Affect | Day 3; abstinence PM | 13.07 score on a scale | Standard Error 0.45 |
| Progesterone 200 mg Capsules | Positive and Negative Affect Schedule (PANAS) Negative Affect | Day 4; abstinence AM | 12.51 score on a scale | Standard Error 0.45 |
| Progesterone 200 mg Capsules | Positive and Negative Affect Schedule (PANAS) Negative Affect | Day 4; abstinence PM | 12.90 score on a scale | Standard Error 0.45 |
| Progesterone 200 mg Capsules | Positive and Negative Affect Schedule (PANAS) Negative Affect | Day 5; after scan, pre-smoking | 12.55 score on a scale | Standard Error 0.45 |
| Progesterone 200 mg Capsules | Positive and Negative Affect Schedule (PANAS) Negative Affect | Day 5; after smoking | 11.41 score on a scale | Standard Error 0.47 |
| Progesterone 200 mg Look-alike Capsules | Positive and Negative Affect Schedule (PANAS) Negative Affect | Day 4; abstinence PM | 13.16 score on a scale | Standard Error 0.46 |
| Progesterone 200 mg Look-alike Capsules | Positive and Negative Affect Schedule (PANAS) Negative Affect | Day 1; pre-1st smoking session | 11.43 score on a scale | Standard Error 0.44 |
| Progesterone 200 mg Look-alike Capsules | Positive and Negative Affect Schedule (PANAS) Negative Affect | Day 3; abstinence PM | 12.89 score on a scale | Standard Error 0.45 |
| Progesterone 200 mg Look-alike Capsules | Positive and Negative Affect Schedule (PANAS) Negative Affect | Day 1; post-1st smoking session | 10.57 score on a scale | Standard Error 0.45 |
| Progesterone 200 mg Look-alike Capsules | Positive and Negative Affect Schedule (PANAS) Negative Affect | Day 5; after smoking | 11.94 score on a scale | Standard Error 0.48 |
| Progesterone 200 mg Look-alike Capsules | Positive and Negative Affect Schedule (PANAS) Negative Affect | Day 2; pre-1st scan | 11.03 score on a scale | Standard Error 0.44 |
| Progesterone 200 mg Look-alike Capsules | Positive and Negative Affect Schedule (PANAS) Negative Affect | Day 4; abstinence AM | 13.06 score on a scale | Standard Error 0.46 |
| Progesterone 200 mg Look-alike Capsules | Positive and Negative Affect Schedule (PANAS) Negative Affect | Day 2; post-2nd scan | 11.49 score on a scale | Standard Error 0.45 |
| Progesterone 200 mg Look-alike Capsules | Positive and Negative Affect Schedule (PANAS) Negative Affect | Day 5; after scan, pre-smoking | 12.18 score on a scale | Standard Error 0.47 |
| Progesterone 200 mg Look-alike Capsules | Positive and Negative Affect Schedule (PANAS) Negative Affect | Day 3; abstinence AM | 13.01 score on a scale | Standard Error 0.46 |
Secondary
Positive and Negative Affect Schedule (PANAS) Positive Affect
Positive and Negative Affect Schedule (PANAS) Positive Affect Score. Ranges from 10-50 with higher scores representing higher levels of positive affect.
Time frame: Day 1 (pre and post smoking session, day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)
Population: Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Progesterone 200 mg Capsules | Positive and Negative Affect Schedule (PANAS) Positive Affect | Day 1; pre-1st smoking session | 37.10 score on a scale | Standard Error 1.24 |
| Progesterone 200 mg Capsules | Positive and Negative Affect Schedule (PANAS) Positive Affect | Day 1; post-1st smoking session | 35.72 score on a scale | Standard Error 1.25 |
| Progesterone 200 mg Capsules | Positive and Negative Affect Schedule (PANAS) Positive Affect | Day 2; pre-1st scan | 36.08 score on a scale | Standard Error 1.24 |
| Progesterone 200 mg Capsules | Positive and Negative Affect Schedule (PANAS) Positive Affect | Day 2; post-2nd scan | 33.51 score on a scale | Standard Error 1.25 |
| Progesterone 200 mg Capsules | Positive and Negative Affect Schedule (PANAS) Positive Affect | Day 3; abstinence AM | 32.57 score on a scale | Standard Error 1.25 |
| Progesterone 200 mg Capsules | Positive and Negative Affect Schedule (PANAS) Positive Affect | Day 3; abstinence PM | 32.34 score on a scale | Standard Error 1.25 |
| Progesterone 200 mg Capsules | Positive and Negative Affect Schedule (PANAS) Positive Affect | Day 4; abstinence AM | 32.56 score on a scale | Standard Error 1.25 |
| Progesterone 200 mg Capsules | Positive and Negative Affect Schedule (PANAS) Positive Affect | Day 4; abstinence PM | 33.25 score on a scale | Standard Error 1.25 |
| Progesterone 200 mg Capsules | Positive and Negative Affect Schedule (PANAS) Positive Affect | Day 5; after scan, pre-smoking | 33.45 score on a scale | Standard Error 1.25 |
| Progesterone 200 mg Capsules | Positive and Negative Affect Schedule (PANAS) Positive Affect | Day 5; after smoking | 33.10 score on a scale | Standard Error 1.25 |
| Progesterone 200 mg Look-alike Capsules | Positive and Negative Affect Schedule (PANAS) Positive Affect | Day 4; abstinence PM | 32.61 score on a scale | Standard Error 1.26 |
| Progesterone 200 mg Look-alike Capsules | Positive and Negative Affect Schedule (PANAS) Positive Affect | Day 1; pre-1st smoking session | 37.23 score on a scale | Standard Error 1.23 |
| Progesterone 200 mg Look-alike Capsules | Positive and Negative Affect Schedule (PANAS) Positive Affect | Day 3; abstinence PM | 32.81 score on a scale | Standard Error 1.25 |
| Progesterone 200 mg Look-alike Capsules | Positive and Negative Affect Schedule (PANAS) Positive Affect | Day 1; post-1st smoking session | 36.11 score on a scale | Standard Error 1.24 |
| Progesterone 200 mg Look-alike Capsules | Positive and Negative Affect Schedule (PANAS) Positive Affect | Day 5; after smoking | 33.76 score on a scale | Standard Error 1.27 |
| Progesterone 200 mg Look-alike Capsules | Positive and Negative Affect Schedule (PANAS) Positive Affect | Day 2; pre-1st scan | 36.55 score on a scale | Standard Error 1.23 |
| Progesterone 200 mg Look-alike Capsules | Positive and Negative Affect Schedule (PANAS) Positive Affect | Day 4; abstinence AM | 32.03 score on a scale | Standard Error 1.25 |
| Progesterone 200 mg Look-alike Capsules | Positive and Negative Affect Schedule (PANAS) Positive Affect | Day 2; post-2nd scan | 34.17 score on a scale | Standard Error 1.25 |
| Progesterone 200 mg Look-alike Capsules | Positive and Negative Affect Schedule (PANAS) Positive Affect | Day 5; after scan, pre-smoking | 32.53 score on a scale | Standard Error 1.27 |
| Progesterone 200 mg Look-alike Capsules | Positive and Negative Affect Schedule (PANAS) Positive Affect | Day 3; abstinence AM | 33.30 score on a scale | Standard Error 1.25 |
Secondary
Profile of Mood State (POMS) Subscale: Vigor
Profile of Mood State (POMS) Subscale: Vigor. Subscale ranges from 0 to 32, with higher levels indicating higher levels of vigor.
Time frame: Day 2 (pre and post scan), Day 5 (pre smoking session)
Population: Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Progesterone 200 mg Capsules | Profile of Mood State (POMS) Subscale: Vigor | Day 2; pre-1st scan | 18.71 score on a scale | Standard Error 0.94 |
| Progesterone 200 mg Capsules | Profile of Mood State (POMS) Subscale: Vigor | Day 2; post-2nd scan | 16.74 score on a scale | Standard Error 0.96 |
| Progesterone 200 mg Capsules | Profile of Mood State (POMS) Subscale: Vigor | Day 5; after scan, pre-smoking | 16.71 score on a scale | Standard Error 0.96 |
| Progesterone 200 mg Look-alike Capsules | Profile of Mood State (POMS) Subscale: Vigor | Day 2; pre-1st scan | 18.71 score on a scale | Standard Error 0.95 |
| Progesterone 200 mg Look-alike Capsules | Profile of Mood State (POMS) Subscale: Vigor | Day 2; post-2nd scan | 16.73 score on a scale | Standard Error 0.96 |
| Progesterone 200 mg Look-alike Capsules | Profile of Mood State (POMS) Subscale: Vigor | Day 5; after scan, pre-smoking | 16.39 score on a scale | Standard Error 0.98 |
Secondary
Profile of Mood States (POMS) Subscale: Anger-Hostility
Profile of Mood States (POMS) Subscale: Anger-Hostility. This scale ranges from 0 to 48 with higher levels indicating higher levels of anger/hostility.
Time frame: Day 2 (pre and post scan), Day 5 (pre smoking session)
Population: Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Progesterone 200 mg Capsules | Profile of Mood States (POMS) Subscale: Anger-Hostility | Day 5; after scan, pre-smoking | 2.70 score on a scale | Standard Error 0.37 |
| Progesterone 200 mg Capsules | Profile of Mood States (POMS) Subscale: Anger-Hostility | Day 2; pre-1st scan | 0.94 score on a scale | Standard Error 0.36 |
| Progesterone 200 mg Capsules | Profile of Mood States (POMS) Subscale: Anger-Hostility | Day 2; post-2nd scan | 1.55 score on a scale | Standard Error 0.37 |
| Progesterone 200 mg Look-alike Capsules | Profile of Mood States (POMS) Subscale: Anger-Hostility | Day 2; post-2nd scan | 1.41 score on a scale | Standard Error 0.37 |
| Progesterone 200 mg Look-alike Capsules | Profile of Mood States (POMS) Subscale: Anger-Hostility | Day 5; after scan, pre-smoking | 2.36 score on a scale | Standard Error 0.39 |
| Progesterone 200 mg Look-alike Capsules | Profile of Mood States (POMS) Subscale: Anger-Hostility | Day 2; pre-1st scan | 0.83 score on a scale | Standard Error 0.36 |
Secondary
Profile of Mood States (POMS) Subscale: Confusion-Bewilderment
Profile of Mood States (POMS) Subscale: Confusion-Bewilderment. Ranges from 0 to 28 with higher levels indicating higher levels of confusion/bewilderment.
Time frame: Day 2 (pre and post scan), Day 5 (pre smoking session)
Population: Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Progesterone 200 mg Capsules | Profile of Mood States (POMS) Subscale: Confusion-Bewilderment | Day 2; pre-1st scan | 2.47 score on a scale | Standard Error 0.35 |
| Progesterone 200 mg Capsules | Profile of Mood States (POMS) Subscale: Confusion-Bewilderment | Day 2; post-2nd scan | 2.95 score on a scale | Standard Error 0.36 |
| Progesterone 200 mg Capsules | Profile of Mood States (POMS) Subscale: Confusion-Bewilderment | Day 5; after scan, pre-smoking | 3.46 score on a scale | Standard Error 0.36 |
| Progesterone 200 mg Look-alike Capsules | Profile of Mood States (POMS) Subscale: Confusion-Bewilderment | Day 2; pre-1st scan | 2.31 score on a scale | Standard Error 0.35 |
| Progesterone 200 mg Look-alike Capsules | Profile of Mood States (POMS) Subscale: Confusion-Bewilderment | Day 2; post-2nd scan | 2.98 score on a scale | Standard Error 0.35 |
| Progesterone 200 mg Look-alike Capsules | Profile of Mood States (POMS) Subscale: Confusion-Bewilderment | Day 5; after scan, pre-smoking | 2.80 score on a scale | Standard Error 0.37 |
Secondary
Profile of Mood States (POMS) Subscale: Depression-Dejection
Profile of Mood States (POMS) Subscale: Depression-Dejection. This subscale ranges from 0-60 with higher levels indicating greater depression/dejection.
Time frame: Day 2 (pre and post scan), Day 5 (pre smoking session)
Population: Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Progesterone 200 mg Capsules | Profile of Mood States (POMS) Subscale: Depression-Dejection | Day 2; pre-1st scan | 1.09 score on a scale | Standard Error 0.34 |
| Progesterone 200 mg Capsules | Profile of Mood States (POMS) Subscale: Depression-Dejection | Day 2; post-2nd scan | 1.30 score on a scale | Standard Error 0.35 |
| Progesterone 200 mg Capsules | Profile of Mood States (POMS) Subscale: Depression-Dejection | Day 5; after scan, pre-smoking | 1.66 score on a scale | Standard Error 0.35 |
| Progesterone 200 mg Look-alike Capsules | Profile of Mood States (POMS) Subscale: Depression-Dejection | Day 2; pre-1st scan | 0.64 score on a scale | Standard Error 0.34 |
| Progesterone 200 mg Look-alike Capsules | Profile of Mood States (POMS) Subscale: Depression-Dejection | Day 2; post-2nd scan | 0.88 score on a scale | Standard Error 0.35 |
| Progesterone 200 mg Look-alike Capsules | Profile of Mood States (POMS) Subscale: Depression-Dejection | Day 5; after scan, pre-smoking | 1.81 score on a scale | Standard Error 0.37 |
Secondary
Profile of Mood States (POMS) Subscale: Fatigue
Profile of Mood States (POMS) Subscale: Fatigue. This subscale ranges from 0 to 28 with higher scores indicating higher levels of fatigue.
Time frame: Day 2 (pre and post scan), Day 5 (pre smoking session)
Population: Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Progesterone 200 mg Capsules | Profile of Mood States (POMS) Subscale: Fatigue | Day 2; pre-1st scan | 2.17 score on a scale | Standard Error 0.48 |
| Progesterone 200 mg Capsules | Profile of Mood States (POMS) Subscale: Fatigue | Day 2; post-2nd scan | 2.84 score on a scale | Standard Error 0.5 |
| Progesterone 200 mg Capsules | Profile of Mood States (POMS) Subscale: Fatigue | Day 5; after scan, pre-smoking | 3.66 score on a scale | Standard Error 0.5 |
| Progesterone 200 mg Look-alike Capsules | Profile of Mood States (POMS) Subscale: Fatigue | Day 2; pre-1st scan | 1.77 score on a scale | Standard Error 0.49 |
| Progesterone 200 mg Look-alike Capsules | Profile of Mood States (POMS) Subscale: Fatigue | Day 2; post-2nd scan | 3.63 score on a scale | Standard Error 0.49 |
| Progesterone 200 mg Look-alike Capsules | Profile of Mood States (POMS) Subscale: Fatigue | Day 5; after scan, pre-smoking | 3.10 score on a scale | Standard Error 0.53 |
Secondary
Profile of Mood States (POMS) Subscale: Tension-Anxiety
Profile of Mood States (POMS) Subscale: Tension-Anxiety. This subscale ranges from 0-28 with higher levels indicating greater tension/anxiety.
Time frame: Day 2 (pre and post scan), Day 5 (pre smoking session)
Population: Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Progesterone 200 mg Capsules | Profile of Mood States (POMS) Subscale: Tension-Anxiety | Day 2; pre-1st scan | 2.88 score on a scale | Standard Error 0.46 |
| Progesterone 200 mg Capsules | Profile of Mood States (POMS) Subscale: Tension-Anxiety | Day 2; post- 2nd scan | 3.55 score on a scale | Standard Error 0.47 |
| Progesterone 200 mg Capsules | Profile of Mood States (POMS) Subscale: Tension-Anxiety | Day 5; after scan, pre-smoking | 4.85 score on a scale | Standard Error 0.47 |
| Progesterone 200 mg Look-alike Capsules | Profile of Mood States (POMS) Subscale: Tension-Anxiety | Day 5; after scan, pre-smoking | 3.70 score on a scale | Standard Error 0.5 |
| Progesterone 200 mg Look-alike Capsules | Profile of Mood States (POMS) Subscale: Tension-Anxiety | Day 2; pre-1st scan | 2.57 score on a scale | Standard Error 0.46 |
| Progesterone 200 mg Look-alike Capsules | Profile of Mood States (POMS) Subscale: Tension-Anxiety | Day 2; post- 2nd scan | 3.11 score on a scale | Standard Error 0.47 |
Secondary
Symptoms During Nicotine Abstinence (NWSC)
Withdrawal symptoms will be measured using the Nicotine Withdrawal Symptoms Checklist (NWSC). The scale ranges from a minimum of 0 to a maximum of 28, with higher scores indicating greater withdrawal (more withdrawal symptoms, higher intensity/severity of withdrawal).
Time frame: Day 1 (pre and post smoking session, day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)
Population: Some secondary outcome data is missing because missed visits and dropouts occurred due to the number of visits required for the study. The study team attempted to limit missing data with payment at each visit for contingency management and allowing participants to continue in the study if individual visits were missed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Progesterone 200 mg Capsules | Symptoms During Nicotine Abstinence (NWSC) | Nicotine withdrawal symptoms checklist (NWSC); day 3 abstinence PM | 6.99 score on a scale | Standard Error 0.6 |
| Progesterone 200 mg Capsules | Symptoms During Nicotine Abstinence (NWSC) | Nicotine withdrawal symptoms checklist (NWSC); day 1 pre 1st smoking session | 6.00 score on a scale | Standard Error 0.59 |
| Progesterone 200 mg Capsules | Symptoms During Nicotine Abstinence (NWSC) | Nicotine withdrawal symptoms checklist (NWSC); day 1 post 1st smoking session | 4.84 score on a scale | Standard Error 0.6 |
| Progesterone 200 mg Capsules | Symptoms During Nicotine Abstinence (NWSC) | Nicotine withdrawal symptoms checklist (NWSC); day 2 pre-scan | 5.67 score on a scale | Standard Error 0.59 |
| Progesterone 200 mg Capsules | Symptoms During Nicotine Abstinence (NWSC) | Nicotine withdrawal symptoms checklist (NWSC); day 2 post-scan | 5.37 score on a scale | Standard Error 0.6 |
| Progesterone 200 mg Capsules | Symptoms During Nicotine Abstinence (NWSC) | Nicotine withdrawal symptoms checklist (NWSC); day 3 abstinence AM | 7.07 score on a scale | Standard Error 0.6 |
| Progesterone 200 mg Capsules | Symptoms During Nicotine Abstinence (NWSC) | Nicotine withdrawal symptoms checklist (NWSC); day 4 abstinence AM | 7.33 score on a scale | Standard Error 0.6 |
| Progesterone 200 mg Capsules | Symptoms During Nicotine Abstinence (NWSC) | Nicotine withdrawal symptoms checklist (NWSC); day 4 abstinence PM | 7.19 score on a scale | Standard Error 0.6 |
| Progesterone 200 mg Capsules | Symptoms During Nicotine Abstinence (NWSC) | Nicotine withdrawal symptoms checklist (NWSC); day 5 pre-smoking | 7.01 score on a scale | Standard Error 0.6 |
| Progesterone 200 mg Capsules | Symptoms During Nicotine Abstinence (NWSC) | Nicotine withdrawal symptoms checklist (NWSC); day 5 post-smoking | 4.60 score on a scale | Standard Error 0.6 |
| Progesterone 200 mg Look-alike Capsules | Symptoms During Nicotine Abstinence (NWSC) | Nicotine withdrawal symptoms checklist (NWSC); day 4 abstinence PM | 7.32 score on a scale | Standard Error 0.61 |
| Progesterone 200 mg Look-alike Capsules | Symptoms During Nicotine Abstinence (NWSC) | Nicotine withdrawal symptoms checklist (NWSC); day 3 abstinence PM | 7.88 score on a scale | Standard Error 0.6 |
| Progesterone 200 mg Look-alike Capsules | Symptoms During Nicotine Abstinence (NWSC) | Nicotine withdrawal symptoms checklist (NWSC); day 3 abstinence AM | 7.62 score on a scale | Standard Error 0.6 |
| Progesterone 200 mg Look-alike Capsules | Symptoms During Nicotine Abstinence (NWSC) | Nicotine withdrawal symptoms checklist (NWSC); day 1 pre 1st smoking session | 6.15 score on a scale | Standard Error 0.58 |
| Progesterone 200 mg Look-alike Capsules | Symptoms During Nicotine Abstinence (NWSC) | Nicotine withdrawal symptoms checklist (NWSC); day 5 post-smoking | 4.82 score on a scale | Standard Error 0.65 |
| Progesterone 200 mg Look-alike Capsules | Symptoms During Nicotine Abstinence (NWSC) | Nicotine withdrawal symptoms checklist (NWSC); day 1 post 1st smoking session | 4.48 score on a scale | Standard Error 0.59 |
| Progesterone 200 mg Look-alike Capsules | Symptoms During Nicotine Abstinence (NWSC) | Nicotine withdrawal symptoms checklist (NWSC); day 4 abstinence AM | 7.66 score on a scale | Standard Error 0.6 |
| Progesterone 200 mg Look-alike Capsules | Symptoms During Nicotine Abstinence (NWSC) | Nicotine withdrawal symptoms checklist (NWSC); day 2 pre-scan | 4.92 score on a scale | Standard Error 0.59 |
| Progesterone 200 mg Look-alike Capsules | Symptoms During Nicotine Abstinence (NWSC) | Nicotine withdrawal symptoms checklist (NWSC); day 5 pre-smoking | 7.34 score on a scale | Standard Error 0.62 |
| Progesterone 200 mg Look-alike Capsules | Symptoms During Nicotine Abstinence (NWSC) | Nicotine withdrawal symptoms checklist (NWSC); day 2 post-scan | 5.25 score on a scale | Standard Error 0.6 |
Secondary
Tiffany Questionnaire on Smoking Urges (TQSU)
Craving will also be assessed using the Tiffany Questionnaire for Smoking Urges. It ranges from 32 to 224 with higher scores indicated higher levels of smoking urges/craving.
Time frame: Day 1 (pre smoking session, day 3 (PM), day 4 (PM), day 5 (pre smoking session)
Population: Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Progesterone 200 mg Capsules | Tiffany Questionnaire on Smoking Urges (TQSU) | Day 1; pre-1st smoking session | 143.45 score on a scale | Standard Error 5.13 |
| Progesterone 200 mg Capsules | Tiffany Questionnaire on Smoking Urges (TQSU) | Day 3; abstinence PM | 138.46 score on a scale | Standard Error 5.23 |
| Progesterone 200 mg Capsules | Tiffany Questionnaire on Smoking Urges (TQSU) | Day 4; abstinence PM | 139.11 score on a scale | Standard Error 5.17 |
| Progesterone 200 mg Capsules | Tiffany Questionnaire on Smoking Urges (TQSU) | Day 5; after scan, pre-smoking | 146.22 score on a scale | Standard Error 5.11 |
| Progesterone 200 mg Look-alike Capsules | Tiffany Questionnaire on Smoking Urges (TQSU) | Day 5; after scan, pre-smoking | 141.08 score on a scale | Standard Error 5.36 |
| Progesterone 200 mg Look-alike Capsules | Tiffany Questionnaire on Smoking Urges (TQSU) | Day 1; pre-1st smoking session | 140.31 score on a scale | Standard Error 5 |
| Progesterone 200 mg Look-alike Capsules | Tiffany Questionnaire on Smoking Urges (TQSU) | Day 4; abstinence PM | 135.88 score on a scale | Standard Error 5.36 |
| Progesterone 200 mg Look-alike Capsules | Tiffany Questionnaire on Smoking Urges (TQSU) | Day 3; abstinence PM | 140.77 score on a scale | Standard Error 5.29 |
Secondary
Visual Analog Scale (VAS) Question: Anxious
Visual Analog Scale (VAS) question: Anxious. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
Time frame: Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)
Population: Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Anxious | Day 2; pre-1st scan | 16.69 score on a scale | Standard Error 3.3 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Anxious | Day 2; post-2nd scan | 15.02 score on a scale | Standard Error 3.3 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Anxious | Day 3; abstinence AM | 20.20 score on a scale | Standard Error 3.38 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Anxious | Day 3; abstinence PM | 16.38 score on a scale | Standard Error 3.4 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Anxious | Day 4; abstinence AM | 18.46 score on a scale | Standard Error 3.38 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Anxious | Day 4; abstinence PM | 15.88 score on a scale | Standard Error 3.38 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Anxious | Day 5; after scan, pre-smoking | 17.81 score on a scale | Standard Error 3.33 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Anxious | Day 5; after smoking | 16.26 score on a scale | Standard Error 3.33 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Anxious | Day 5; after smoking | 15.30 score on a scale | Standard Error 3.48 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Anxious | Day 2; pre-1st scan | 15.62 score on a scale | Standard Error 3.28 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Anxious | Day 4; abstinence AM | 15.08 score on a scale | Standard Error 3.4 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Anxious | Day 2; post-2nd scan | 12.65 score on a scale | Standard Error 3.31 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Anxious | Day 5; after scan, pre-smoking | 19.05 score on a scale | Standard Error 3.44 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Anxious | Day 3; abstinence AM | 17.38 score on a scale | Standard Error 3.38 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Anxious | Day 4; abstinence PM | 15.63 score on a scale | Standard Error 3.44 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Anxious | Day 3; abstinence PM | 20.23 score on a scale | Standard Error 3.38 |
Secondary
Visual Analog Scale (VAS) Question: Calm
Visual Analog Scale (VAS) question: Calm. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
Time frame: Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)
Population: Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Calm | Day 2; pre-1st scan | 74.35 score on a scale | Standard Error 3.6 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Calm | Day 2; post-2nd scan | 73.15 score on a scale | Standard Error 3.6 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Calm | Day 3; abstinence AM | 65.65 score on a scale | Standard Error 3.71 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Calm | Day 3; abstinence PM | 58.92 score on a scale | Standard Error 3.73 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Calm | Day 4; abstinence AM | 60.23 score on a scale | Standard Error 3.71 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Calm | Day 4; abstinence PM | 65.47 score on a scale | Standard Error 3.71 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Calm | Day 5; after scan, pre-smoking | 67.60 score on a scale | Standard Error 3.78 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Calm | Day 5; after smoking | 69.27 score on a scale | Standard Error 3.65 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Calm | Day 5; after smoking | 70.52 score on a scale | Standard Error 3.83 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Calm | Day 2; pre-1st scan | 76.52 score on a scale | Standard Error 3.58 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Calm | Day 4; abstinence AM | 57.97 score on a scale | Standard Error 3.73 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Calm | Day 2; post-2nd scan | 69.23 score on a scale | Standard Error 3.62 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Calm | Day 5; after scan, pre-smoking | 61.02 score on a scale | Standard Error 3.65 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Calm | Day 3; abstinence AM | 61.15 score on a scale | Standard Error 3.71 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Calm | Day 4; abstinence PM | 62.48 score on a scale | Standard Error 3.78 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Calm | Day 3; abstinence PM | 52.44 score on a scale | Standard Error 3.71 |
Secondary
Visual Analog Scale (VAS) Question: Depressed
Visual Analog Scale (VAS) question: Depressed. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
Time frame: Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)
Population: Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Depressed | Day 2; pre-1st scan | 3.97 score on a scale | Standard Error 1.52 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Depressed | Day 2; post-2nd scan | 4.99 score on a scale | Standard Error 1.52 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Depressed | Day 3; abstinence AM | 6.43 score on a scale | Standard Error 1.57 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Depressed | Day 3; abstinence PM | 4.61 score on a scale | Standard Error 1.58 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Depressed | Day 4; abstinence AM | 5.51 score on a scale | Standard Error 1.57 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Depressed | Day 4; abstinence PM | 5.67 score on a scale | Standard Error 1.57 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Depressed | Day 5; after scan, pre-smoking | 2.64 score on a scale | Standard Error 1.54 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Depressed | Day 5; after smoking | 2.53 score on a scale | Standard Error 1.54 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Depressed | Day 5; after smoking | 4.89 score on a scale | Standard Error 1.63 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Depressed | Day 2; pre-1st scan | 2.87 score on a scale | Standard Error 1.52 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Depressed | Day 4; abstinence AM | 5.17 score on a scale | Standard Error 1.58 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Depressed | Day 2; post-2nd scan | 5.55 score on a scale | Standard Error 1.53 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Depressed | Day 5; after scan, pre-smoking | 5.26 score on a scale | Standard Error 1.6 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Depressed | Day 3; abstinence AM | 6.85 score on a scale | Standard Error 1.57 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Depressed | Day 4; abstinence PM | 5.73 score on a scale | Standard Error 1.6 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Depressed | Day 3; abstinence PM | 4.58 score on a scale | Standard Error 1.57 |
Secondary
Visual Analog Scale (VAS) Question: Drowsy
Visual Analog Scale (VAS) question: Drowsy. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
Time frame: Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)
Population: Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Drowsy | Day 2; pre-1st scan | 16.63 score on a scale | Standard Error 3.53 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Drowsy | Day 2; post-2nd scan | 24.25 score on a scale | Standard Error 3.53 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Drowsy | Day 3; abstinence AM | 17.14 score on a scale | Standard Error 3.65 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Drowsy | Day 3; abstinence PM | 24.71 score on a scale | Standard Error 3.67 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Drowsy | Day 4; abstinence AM | 19.56 score on a scale | Standard Error 3.65 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Drowsy | Day 4; abstinence PM | 19.84 score on a scale | Standard Error 3.65 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Drowsy | Day 5; after scan, pre-smoking | 23.01 score on a scale | Standard Error 3.58 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Drowsy | Day 5; after smoking | 20.45 score on a scale | Standard Error 3.58 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Drowsy | Day 5; after smoking | 21.45 score on a scale | Standard Error 3.78 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Drowsy | Day 2; pre-1st scan | 14.29 score on a scale | Standard Error 3.51 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Drowsy | Day 4; abstinence AM | 18.32 score on a scale | Standard Error 3.67 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Drowsy | Day 2; post-2nd scan | 30.17 score on a scale | Standard Error 3.55 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Drowsy | Day 5; after scan, pre-smoking | 21.01 score on a scale | Standard Error 3.72 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Drowsy | Day 3; abstinence AM | 15.43 score on a scale | Standard Error 3.65 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Drowsy | Day 4; abstinence PM | 20.50 score on a scale | Standard Error 3.72 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Drowsy | Day 3; abstinence PM | 24.36 score on a scale | Standard Error 3.65 |
Secondary
Visual Analog Scale (VAS) Question: Energetic
Visual Analog Scale (VAS) question: Energetic. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
Time frame: Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)
Population: Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Energetic | Day 2; pre-1st scan | 54.86 score on a scale | Standard Error 3.68 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Energetic | Day 2; post-2nd scan | 55.18 score on a scale | Standard Error 3.68 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Energetic | Day 3; abstinence AM | 56.14 score on a scale | Standard Error 3.77 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Energetic | Day 3; abstinence PM | 56.13 score on a scale | Standard Error 3.79 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Energetic | Day 4; abstinence AM | 55.62 score on a scale | Standard Error 3.77 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Energetic | Day 4; abstinence PM | 53.45 score on a scale | Standard Error 3.77 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Energetic | Day 5; after scan, pre-smoking | 51.47 score on a scale | Standard Error 3.72 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Energetic | Day 5; after smoking | 54.79 score on a scale | Standard Error 3.72 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Energetic | Day 5; after smoking | 54.70 score on a scale | Standard Error 3.87 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Energetic | Day 2; pre-1st scan | 67.01 score on a scale | Standard Error 3.66 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Energetic | Day 4; abstinence AM | 54.89 score on a scale | Standard Error 3.79 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Energetic | Day 2; post-2nd scan | 21.03 score on a scale | Standard Error 3.69 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Energetic | Day 5; after scan, pre-smoking | 56.64 score on a scale | Standard Error 3.83 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Energetic | Day 3; abstinence AM | 58.11 score on a scale | Standard Error 3.77 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Energetic | Day 4; abstinence PM | 56.77 score on a scale | Standard Error 3.83 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Energetic | Day 3; abstinence PM | 50.12 score on a scale | Standard Error 3.77 |
Secondary
Visual Analog Scale (VAS) Question: Happy
Visual Analog Scale (VAS) question: Happy. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
Time frame: Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)
Population: Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Happy | Day 2; pre-1st scan | 76.62 score on a scale | Standard Error 3.39 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Happy | Day 2; post-2nd scan | 70.98 score on a scale | Standard Error 3.39 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Happy | Day 3; abstinence AM | 66.22 score on a scale | Standard Error 3.47 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Happy | Day 3; abstinence PM | 65.10 score on a scale | Standard Error 3.49 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Happy | Day 4; abstinence AM | 62.76 score on a scale | Standard Error 3.47 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Happy | Day 4; abstinence PM | 61.99 score on a scale | Standard Error 3.47 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Happy | Day 5; after scan, pre-smoking | 66.59 score on a scale | Standard Error 3.42 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Happy | Day 5; after smoking | 70.07 score on a scale | Standard Error 3.42 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Happy | Day 5; after smoking | 67.87 score on a scale | Standard Error 3.56 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Happy | Day 2; pre-1st scan | 79.70 score on a scale | Standard Error 3.37 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Happy | Day 4; abstinence AM | 60.58 score on a scale | Standard Error 3.49 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Happy | Day 2; post-2nd scan | 71.34 score on a scale | Standard Error 3.4 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Happy | Day 5; after scan, pre-smoking | 63.46 score on a scale | Standard Error 3.52 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Happy | Day 3; abstinence AM | 64.04 score on a scale | Standard Error 3.47 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Happy | Day 4; abstinence PM | 63.95 score on a scale | Standard Error 3.52 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Happy | Day 3; abstinence PM | 61.30 score on a scale | Standard Error 3.47 |
Secondary
Visual Analog Scale (VAS) Question: Headache
Visual Analog Scale (VAS) question: Headache. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
Time frame: Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)
Population: Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Headache | Day 2; pre-1st scan | 6.50 score on a scale | Standard Error 2.55 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Headache | Day 2; post-2nd scan | 5.74 score on a scale | Standard Error 2.55 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Headache | Day 3; abstinence AM | 9.15 score on a scale | Standard Error 2.65 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Headache | Day 3; abstinence PM | 8.86 score on a scale | Standard Error 2.67 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Headache | Day 4; abstinence AM | 10.88 score on a scale | Standard Error 2.65 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Headache | Day 4; abstinence PM | 11.83 score on a scale | Standard Error 2.65 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Headache | Day 5; after scan, pre-smoking | 9.05 score on a scale | Standard Error 2.59 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Headache | Day 5; after smoking | 11.93 score on a scale | Standard Error 2.59 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Headache | Day 5; after smoking | 11.67 score on a scale | Standard Error 2.75 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Headache | Day 2; pre-1st scan | 7.59 score on a scale | Standard Error 2.54 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Headache | Day 4; abstinence AM | 7.70 score on a scale | Standard Error 2.67 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Headache | Day 2; post-2nd scan | 9.39 score on a scale | Standard Error 2.57 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Headache | Day 5; after scan, pre-smoking | 13.36 score on a scale | Standard Error 2.71 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Headache | Day 3; abstinence AM | 14.71 score on a scale | Standard Error 2.65 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Headache | Day 4; abstinence PM | 12.78 score on a scale | Standard Error 2.71 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Headache | Day 3; abstinence PM | 10.93 score on a scale | Standard Error 2.65 |
Secondary
Visual Analog Scale (VAS) Question: Heartburn.
Visual Analog Scale (VAS) question: Heartburn. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
Time frame: Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)
Population: Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Heartburn. | Day 2; pre-1st scan | 3.11 score on a scale | Standard Error 1.7 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Heartburn. | Day 2; post-2nd scan | 4.30 score on a scale | Standard Error 1.7 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Heartburn. | Day 3; abstinence AM | 5.46 score on a scale | Standard Error 1.76 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Heartburn. | Day 3; abstinence PM | 6.00 score on a scale | Standard Error 1.78 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Heartburn. | Day 4; abstinence AM | 7.31 score on a scale | Standard Error 1.76 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Heartburn. | Day 4; abstinence PM | 5.51 score on a scale | Standard Error 1.76 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Heartburn. | Day 5; after scan, pre-smoking | 4.33 score on a scale | Standard Error 1.73 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Heartburn. | Day 5; after smoking | 4.56 score on a scale | Standard Error 1.73 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Heartburn. | Day 5; after smoking | 6.37 score on a scale | Standard Error 1.83 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Heartburn. | Day 2; pre-1st scan | 2.35 score on a scale | Standard Error 1.69 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Heartburn. | Day 4; abstinence AM | 6.50 score on a scale | Standard Error 1.78 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Heartburn. | Day 2; post-2nd scan | 4.06 score on a scale | Standard Error 1.71 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Heartburn. | Day 5; after scan, pre-smoking | 5.30 score on a scale | Standard Error 1.8 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Heartburn. | Day 3; abstinence AM | 3.27 score on a scale | Standard Error 1.76 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Heartburn. | Day 4; abstinence PM | 5.56 score on a scale | Standard Error 1.8 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Heartburn. | Day 3; abstinence PM | 4.55 score on a scale | Standard Error 1.76 |
Secondary
Visual Analog Scale (VAS) Question: Hunger
Visual Analog Scale (VAS) question: Hunger. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
Time frame: Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)
Population: Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Hunger | Day 5; after scan, pre-smoking | 28.22 score on a scale | Standard Error 3.78 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Hunger | Day 3; abstinence AM | 24.88 score on a scale | Standard Error 3.85 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Hunger | Day 2; pre-1st scan | 34.60 score on a scale | Standard Error 3.73 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Hunger | Day 3; abstinence PM | 27.72 score on a scale | Standard Error 3.87 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Hunger | Day 5; after smoking | 28.63 score on a scale | Standard Error 3.78 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Hunger | Day 4; abstinence AM | 27.94 score on a scale | Standard Error 3.85 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Hunger | Day 2; post-2nd scan | 28.63 score on a scale | Standard Error 3.75 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Hunger | Day 4; abstinence PM | 25.57 score on a scale | Standard Error 3.85 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Hunger | Day 2; post-2nd scan | 22.20 score on a scale | Standard Error 3.73 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Hunger | Day 5; after scan, pre-smoking | 35.22 score on a scale | Standard Error 3.93 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Hunger | Day 5; after smoking | 32.61 score on a scale | Standard Error 3.99 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Hunger | Day 2; pre-1st scan | 40.23 score on a scale | Standard Error 3.7 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Hunger | Day 4; abstinence PM | 29.27 score on a scale | Standard Error 3.93 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Hunger | Day 3; abstinence AM | 33.40 score on a scale | Standard Error 3.85 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Hunger | Day 3; abstinence PM | 31.95 score on a scale | Standard Error 3.85 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Hunger | Day 4; abstinence AM | 34.64 score on a scale | Standard Error 3.88 |
Secondary
Visual Analog Scale (VAS) Question: Irritable
Visual Analog Scale (VAS) question: Irritable. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
Time frame: Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)
Population: Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Irritable | Day 4; abstinence AM | 30.79 score on a scale | Standard Error 3.54 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Irritable | Day 3; abstinence PM | 23.97 score on a scale | Standard Error 3.56 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Irritable | Day 4; abstinence PM | 26.50 score on a scale | Standard Error 3.54 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Irritable | Day 2; post-2nd scan | 13.20 score on a scale | Standard Error 3.42 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Irritable | Day 5; after scan, pre-smoking | 23.23 score on a scale | Standard Error 3.47 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Irritable | Day 2; pre-1st scan | 7.50 score on a scale | Standard Error 3.42 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Irritable | Day 5; after smoking | 13.45 score on a scale | Standard Error 3.47 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Irritable | Day 3; abstinence AM | 24.80 score on a scale | Standard Error 3.54 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Irritable | Day 5; after smoking | 15.52 score on a scale | Standard Error 3.66 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Irritable | Day 4; abstinence AM | 29.58 score on a scale | Standard Error 3.56 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Irritable | Day 2; pre-1st scan | 5.71 score on a scale | Standard Error 3.4 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Irritable | Day 2; post-2nd scan | 13.01 score on a scale | Standard Error 3.44 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Irritable | Day 3; abstinence AM | 24.56 score on a scale | Standard Error 3.54 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Irritable | Day 4; abstinence PM | 30.11 score on a scale | Standard Error 3.61 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Irritable | Day 5; after scan, pre-smoking | 22.96 score on a scale | Standard Error 3.61 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Irritable | Day 3; abstinence PM | 25.49 score on a scale | Standard Error 3.54 |
Secondary
Visual Analog Scale (VAS) Question: Nauseous
Visual Analog Scale (VAS) question: Nauseous. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
Time frame: Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)
Population: Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Nauseous | Day 2; pre-1st scan | 5.52 score on a scale | Standard Error 2.07 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Nauseous | Day 2; post-2nd scan | 6.31 score on a scale | Standard Error 2.07 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Nauseous | Day 3; abstinence AM | 6.01 score on a scale | Standard Error 2.14 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Nauseous | Day 3; abstinence PM | 8.07 score on a scale | Standard Error 2.15 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Nauseous | Day 4; abstinence AM | 6.07 score on a scale | Standard Error 2.14 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Nauseous | Day 4; abstinence PM | 6.60 score on a scale | Standard Error 2.18 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Nauseous | Day 5; after scan, pre-smoking | 6.51 score on a scale | Standard Error 2.1 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Nauseous | Day 5; after smoking | 8.00 score on a scale | Standard Error 2.1 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Nauseous | Day 5; after smoking | 11.41 score on a scale | Standard Error 2.22 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Nauseous | Day 2; pre-1st scan | 4.92 score on a scale | Standard Error 2.06 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Nauseous | Day 4; abstinence AM | 8.22 score on a scale | Standard Error 2.15 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Nauseous | Day 2; post-2nd scan | 5.43 score on a scale | Standard Error 2.08 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Nauseous | Day 5; after scan, pre-smoking | 10.34 score on a scale | Standard Error 2.18 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Nauseous | Day 3; abstinence AM | 10.44 score on a scale | Standard Error 2.14 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Nauseous | Day 4; abstinence PM | 10.29 score on a scale | Standard Error 2.18 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Nauseous | Day 3; abstinence PM | 9.85 score on a scale | Standard Error 2.14 |
Secondary
Visual Analog Scale (VAS) Question: Nervous
Visual Analog Scale (VAS) question: Nervous. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
Time frame: Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)
Population: Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Nervous | Day 2; pre-1st scan | 13.24 score on a scale | Standard Error 2.5 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Nervous | Day 2; post-2nd scan | 10.91 score on a scale | Standard Error 2.5 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Nervous | Day 3; abstinence AM | 7.19 score on a scale | Standard Error 2.57 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Nervous | Day 3; abstinence PM | 9.56 score on a scale | Standard Error 2.59 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Nervous | Day 4; abstinence AM | 9.36 score on a scale | Standard Error 2.57 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Nervous | Day 4; abstinence PM | 10.83 score on a scale | Standard Error 2.57 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Nervous | Day 5; after scan, pre-smoking | 10.79 score on a scale | Standard Error 2.53 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Nervous | Day 5; after smoking | 7.64 score on a scale | Standard Error 2.53 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Nervous | Day 5; after smoking | 11.94 score on a scale | Standard Error 2.65 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Nervous | Day 2; pre-1st scan | 10.26 score on a scale | Standard Error 2.49 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Nervous | Day 4; abstinence AM | 11.37 score on a scale | Standard Error 2.59 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Nervous | Day 2; post-2nd scan | 8.46 score on a scale | Standard Error 2.52 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Nervous | Day 5; after scan, pre-smoking | 12.15 score on a scale | Standard Error 2.62 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Nervous | Day 3; abstinence AM | 8.22 score on a scale | Standard Error 2.57 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Nervous | Day 4; abstinence PM | 10.66 score on a scale | Standard Error 2.62 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Nervous | Day 3; abstinence PM | 9.24 score on a scale | Standard Error 2.57 |
Secondary
Visual Analog Scale (VAS) Question: Relaxed
Visual Analog Scale (VAS) question: Relaxed. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
Time frame: Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)
Population: Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Relaxed | Day 5; after smoking | 67.99 score on a scale | Standard Error 3.86 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Relaxed | Day 2; post-2nd scan | 67.77 score on a scale | Standard Error 3.64 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Relaxed | Day 3; abstinence AM | 63.87 score on a scale | Standard Error 3.75 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Relaxed | Day 3; abstinence PM | 57.69 score on a scale | Standard Error 3.77 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Relaxed | Day 4; abstinence AM | 57.83 score on a scale | Standard Error 3.75 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Relaxed | Day 4; abstinence PM | 63.46 score on a scale | Standard Error 3.75 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Relaxed | Day 5; after scan, pre-smoking | 62.45 score on a scale | Standard Error 3.68 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Relaxed | Day 2; pre-1st scan | 72.66 score on a scale | Standard Error 3.64 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Relaxed | Day 4; abstinence PM | 63.45 score on a scale | Standard Error 3.84 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Relaxed | Day 2; pre-1st scan | 73.87 score on a scale | Standard Error 3.64 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Relaxed | Day 5; after smoking | 67.55 score on a scale | Standard Error 3.68 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Relaxed | Day 2; post-2nd scan | 63.65 score on a scale | Standard Error 3.67 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Relaxed | Day 4; abstinence AM | 55.37 score on a scale | Standard Error 3.79 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Relaxed | Day 3; abstinence AM | 55.85 score on a scale | Standard Error 3.77 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Relaxed | Day 5; after scan, pre-smoking | 67.65 score on a scale | Standard Error 3.81 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Relaxed | Day 3; abstinence PM | 54.08 score on a scale | Standard Error 3.77 |
Secondary
Visual Analog Scale (VAS) Question: Sad
Visual Analog Scale (VAS) question: Sad. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
Time frame: Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)
Population: Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Sad | Day 2; pre-1st scan | 3.95 score on a scale | Standard Error 1.87 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Sad | Day 2; post-2nd scan | 6.77 score on a scale | Standard Error 1.87 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Sad | Day 3; abstinence AM | 5.67 score on a scale | Standard Error 1.93 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Sad | Day 3; abstinence PM | 4.36 score on a scale | Standard Error 1.95 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Sad | Day 4; abstinence AM | 8.54 score on a scale | Standard Error 1.93 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Sad | Day 4; abstinence PM | 7.32 score on a scale | Standard Error 1.93 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Sad | Day 5; after scan, pre-smoking | 3.87 score on a scale | Standard Error 1.89 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Sad | Day 5; after smoking | 2.95 score on a scale | Standard Error 1.89 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Sad | Day 5; after smoking | 5.92 score on a scale | Standard Error 2.01 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Sad | Day 2; pre-1st scan | 2.09 score on a scale | Standard Error 1.85 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Sad | Day 4; abstinence AM | 8.47 score on a scale | Standard Error 1.95 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Sad | Day 2; post-2nd scan | 4.48 score on a scale | Standard Error 1.88 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Sad | Day 5; after scan, pre-smoking | 12.47 score on a scale | Standard Error 1.98 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Sad | Day 3; abstinence AM | 10.51 score on a scale | Standard Error 1.93 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Sad | Day 4; abstinence PM | 8.65 score on a scale | Standard Error 1.98 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Sad | Day 3; abstinence PM | 9.07 score on a scale | Standard Error 1.93 |
Secondary
Visual Analog Scale (VAS) Question: Talkative
Visual Analog Scale (VAS) question: Headache. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
Time frame: Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)
Population: Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Talkative | Day 2; pre-1st scan | 54.17 score on a scale | Standard Error 3.76 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Talkative | Day 2; post-2nd scan | 50.61 score on a scale | Standard Error 3.76 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Talkative | Day 3; abstinence AM | 51.43 score on a scale | Standard Error 3.84 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Talkative | Day 3; abstinence PM | 48.14 score on a scale | Standard Error 3.86 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Talkative | Day 4; abstinence AM | 49.67 score on a scale | Standard Error 3.84 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Talkative | Day 4; abstinence PM | 50.48 score on a scale | Standard Error 3.84 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Talkative | Day 5; after scan, pre-smoking | 52.74 score on a scale | Standard Error 3.8 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Talkative | Day 5; after smoking | 54.26 score on a scale | Standard Error 3.8 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Talkative | Day 5; after smoking | 53.12 score on a scale | Standard Error 3.93 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Talkative | Day 2; pre-1st scan | 57.46 score on a scale | Standard Error 3.75 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Talkative | Day 4; abstinence AM | 50.71 score on a scale | Standard Error 3.86 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Talkative | Day 2; post-2nd scan | 51.46 score on a scale | Standard Error 3.78 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Talkative | Day 5; after scan, pre-smoking | 56.19 score on a scale | Standard Error 3.9 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Talkative | Day 3; abstinence AM | 50.34 score on a scale | Standard Error 3.84 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Talkative | Day 4; abstinence PM | 49.27 score on a scale | Standard Error 3.9 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Talkative | Day 3; abstinence PM | 47.04 score on a scale | Standard Error 3.84 |
Secondary
Visual Analog Scale (VAS) Question: Tired
Visual Analog Scale (VAS) question: Tired. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
Time frame: Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)
Population: Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Tired | Day 5; after smoking | 31.22 score on a scale | Standard Error 3.82 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Tired | Day 3; abstinence PM | 30.82 score on a scale | Standard Error 3.91 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Tired | Day 2; post-2nd scan | 29.67 score on a scale | Standard Error 3.76 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Tired | Day 4; abstinence AM | 31.73 score on a scale | Standard Error 3.89 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Tired | Day 2; pre-1st scan | 24.15 score on a scale | Standard Error 3.76 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Tired | Day 4; abstinence PM | 30.69 score on a scale | Standard Error 3.89 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Tired | Day 3; abstinence AM | 21.64 score on a scale | Standard Error 3.89 |
| Progesterone 200 mg Capsules | Visual Analog Scale (VAS) Question: Tired | Day 5; after scan, pre-smoking | 33.94 score on a scale | Standard Error 3.82 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Tired | Day 5; after smoking | 34.79 score on a scale | Standard Error 4.03 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Tired | Day 5; after scan, pre-smoking | 32.06 score on a scale | Standard Error 3.97 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Tired | Day 2; pre-1st scan | 18.62 score on a scale | Standard Error 3.74 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Tired | Day 2; post-2nd scan | 40.92 score on a scale | Standard Error 3.79 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Tired | Day 3; abstinence AM | 27.24 score on a scale | Standard Error 3.89 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Tired | Day 3; abstinence PM | 35.53 score on a scale | Standard Error 3.89 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Tired | Day 4; abstinence AM | 27.99 score on a scale | Standard Error 3.92 |
| Progesterone 200 mg Look-alike Capsules | Visual Analog Scale (VAS) Question: Tired | Day 4; abstinence PM | 28.51 score on a scale | Standard Error 3.97 |