Smoking Cessation
Conditions
Keywords
Smoking Cessation, Nicotine Cessation
Brief summary
This will be a double-blind, placebo-controlled, pilot, randomized clinical trial. A total of 50 women who smoke and have regular menstrual cycles will be randomized to either progesterone (200 mgs BID) + Transdermal Nicotine Patch (TNP) or placebo + TNP for 8 weeks. TNP will be tapered after 4-6 weeks. Progesterone or matching placebo will be discontinued at the end of Week 8. All participants will also be provided behavioral treatment for smoking cessation. Participants will be inducted onto progesterone (or placebo) + TNP over a one-week period (Week 1) during the mid luteal phase, within a week before menses and the target quit date will be set for the 5 (+/-2) days after onset of menses. Participants will have post-trial follow-up visits at 1 and 3 months.The main study outcomes will be self- report of smoking abstinence, biochemically verified smoking abstinence, measures of cigarette craving and nicotine withdrawal, and measures of response inhibition.
Detailed description
This study seeks to determine if modifying the hormonal milieu of the menstrual cycle, through administration of exogenous progesterone, will improve the effectiveness of treatments for smoking cessation in women. Progesterone, a gonadal hormone, is used clinically for treatment of endometrial hyperplasia, amenorrhea, dysfunctional uterine bleeding, and for assisted reproduction in women. Progesterone also shows promise for the treatment of multiple central nervous system disorders including cocaine addiction, seizure disorder, and traumatic brain injury. As the next step, the investigators seek to determine if progesterone augments standard smoking cessation treatments (e.g., NRT) in regularly cycling women. The investigators hypothesize that co-treatment with progesterone, compared to placebo, will enhance the effectiveness NRT for smoking cessation. To test this hypothesis, the investigators propose an 8-week, double-blind, placebo-controlled clinical trial, which will randomize 50 smokers using a 1:1 assignment ratio to 400 mg/day progesterone or placebo. Consistent with the Clinical Practice Guidelines, all participants will also receive transdermal nicotine patch (TNP) plus brief counseling for smoking cessation during the study participation. Specific Aim #1: To determine if progesterone +TNP is superior to placebo +TNP for prolonged and 7-day point prevalence of smoking abstinence rates at the end of 8 weeks of treatment and at 1 and 3 month follow-up time points. The investigators will also evaluate the safety and tolerability of progesterone treatment, compared to placebo. Our co-primary outcome measures will be 7-day point prevalence of smoking abstinence and breath CO at the end of treatment and 1- and 3-months after the end of the trial. Specific Aim #2: To determine if progesterone + TNP treatment, compared to placebo + TNP, improves response inhibitory function, as assessed by the Stroop, The Go/No Go task, and the Digit Symbol Task. Specific Aim # 3: To determine if progesterone + TNP treatment, compared to placebo + TNP, leads to a greater reduction in cigarette craving and nicotine withdrawal symptoms, as assessed by the Questionnaire on Smoking Urges-Brief (QSU-B) and the Minnesota Nicotine Withdrawal Scale (MNWS), respectively. Specific Aim #4: To evaluate with affective changes, as shown on the Positive and Negative Affect Schedule, mediates the effects of progesterone on smoking abstinence.
Interventions
DRUGProgesterone (200 mgs BID)
Transdermal Nicotine Patch (TNP) + Progesterone
DRUGPlacebo
TNP + Placebo
Sponsors
National Cancer Institute (NCI)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Aged 18 - 45 * Smoking at least 5 cigarettes/ day for at least one year * Regular menstrual cycles every 24-36 days for the previous 6 months * Motivated to quit smoking (i.e., a rating of at least 7 on a 10-point scale where 1 is not at all motivated and 10 is extremely motivated) * In good health * Using an acceptable, non-hormonal birth control
Exclusion criteria
A history of major medical or psychological illnesses including: * liver disease * heart disease * diabetes * malignancy including history of breast cancer * deep vein thrombosis * blood coagulation problems including a history or family history of thrombophilia * liver failure * cervical intra-epithelial lesions III or greater that are untreated * other medical conditions that the physician investigators deems will make study participation unsafe for the subject * current or past history bipolar disorder or schizophrenia * current diagnosis of major depression * panic disorder or post-traumatic stress disorder * active drug (non-nicotine) and/or alcohol dependence * currently undergoing treatment with another pharmacological agent for smoking cessation * regular use of sedating medications including sleeping aids, antihistamines, and others use of nicotine from cigars, pipes, chewing tobacco * pregnant * breast- feeding or intending to become pregnant within 6 months * allergy to nicotine patch or progesterone * allergy to peanuts or other nuts.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 7-day Point Prevalence of Smoking Abstinence | end of 8 weeks of treatment | The 7-day point prevalence is defined by self-reported smoking abstinence for the last 7 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Stroop Measure of Inhibitory Function | baseline and week 2 | The Stroop test assesses cognitive processing. The Level 3 Stroop Throughput score incorporates both accuracy and speed. In Level 3 of the Stroop test, a series of words representing colors are shown in a font color that is incongruent with the word (e.g. RED would be shown in blue font). Users are asked to press a response key associated with the color of the font, not the written word. Quicker and more accurate responses lead to higher scores. The lowest possible score is 0 (no correct responses). There is no defined maximum score, as the score depends upon both response time and number of correct responses. A Level 3 Stroop Throughput change score was calculated by subtracting baseline score from week 2 score. Higher positive scores represent greater improvement in scores at week 2 relative to baseline, and lower negative scores represent greater decline in scores from baseline to week 2. |
| Change in Go/No Go Task Measure of Inhibitory Function | baseline and week 2 | Week 2 minus baseline. This task assesses the ability to withhold responses to an infrequently occurring target (No-Go trials). A total of 225 single digits (25 x 9 digits) are presented on a computer monitor for 250 ms each, immediately followed by a mask for 900 ms. Subjects must press a spacebar in response to every digit except the 3. Go/No Go score is calculated as separation between the means of the signal and the noise distributions and is reported in standard deviation units, representing an overall indicator of performance since it accounts for correct responses and incorrect responses. Higher scores represent a better outcome. For the change score, higher positive scores represent greater improvement in scores between baseline and week 2, and lower negative scores represent greater decline in scores between baseline and week 2. |
| Change in Digit Symbol Task Measure of Inhibitory Function | baseline and week 2 | The Code Substitution Test (a computerized adaptation/variant of the Digit Symbol Substitution Test) is a test of psychomotor performance. The Code Substitution-Learning Throughput Score incorporates both accuracy and speed. During the learning phase of this test, users are continuously shown a row of 9 digits that are paired with a symbol (the pairings are constant). Users are presented with a series of individual pairings and are asked to press a response key to indicate if the pairing is correct or not. Quicker and more accurate responses lead to higher scores. The lowest possible score is 0 (no correct responses). There is no defined maximum score, as the score depends upon both response time and number of correct responses. A change score was calculated by subtracting baseline score from week 2 score. Higher positive scores represent greater improvement in scores at week 2 relative to baseline, and lower negative scores represent greater decline in scores from baseline to week 2. |
| Carbon Monoxide <10 Ppm | end of 8 weeks of treatment | Smoking abstinence measured by breath CO |
| Prolonged Abstinence Post Trial | 1-month follow-up after end of treatment | Abstinence from 2 weeks post quit date to the one month follow up |
| Prolonged Abstinence Follow up | 3-month follow-up after end of treatment | Abstinence from 2 weeks post quit date to 3 month follow up (total of 6-8 weeks during the trial and 3 month follow up) |
| Positive and Negative Affect Schedule (PANAS) Total Score | Baseline | The PANAS questionnaire consists of 20 items that describe different feelings and emotions. Participants are asked to what extent they feel this way right now on 5-point scale ranging from 1 (very slightly or not at all) to 5 (extremely). Separate Positive Affect Scores and Negative Affect Scores were calculated from 10 items each. Scores can range from 10 t0 50, with higher scores representing higher levels of positive affect and with lower scores representing lower levels of negative affect. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TNP + Progesterone Transdermal Nicotine Patch + Progesterone (200 mgs BID)
Progesterone (200 mgs BID): TNP + Progesterone | 33 |
| TNP + Placebo Transdermal Nicotine Patch + Placebo (for Progesterone)
Placebo: TNP + Placebo | 31 |
| Total | 64 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 1-Month Follow-Up | Withdrawal by Subject | 1 | 0 |
| Treatment Period | Lost to Follow-up | 12 | 6 |
| Treatment Period | Withdrawal by Subject | 1 | 3 |
Baseline characteristics
| Characteristic | Total | TNP + Placebo | TNP + Progesterone |
|---|---|---|---|
| Age, Continuous | 32.6 years STANDARD_DEVIATION 7.7 | 33.0 years STANDARD_DEVIATION 8 | 32.3 years STANDARD_DEVIATION 7.6 |
| Cigarettes per day | 12.3 cigarettes per day STANDARD_DEVIATION 7.2 | 13.2 cigarettes per day STANDARD_DEVIATION 7.3 | 11.4 cigarettes per day STANDARD_DEVIATION 7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 4 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 51 Participants | 27 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Lives with smoker Does not live with smoker | 26 Participants | 12 Participants | 14 Participants |
| Lives with smoker Lives with smoker | 38 Participants | 19 Participants | 19 Participants |
| Motivation to quit smoking | 8.9 units on a scale STANDARD_DEVIATION 1.2 | 8.9 units on a scale STANDARD_DEVIATION 1.3 | 9.0 units on a scale STANDARD_DEVIATION 1.1 |
| Race/Ethnicity, Customized Black or African American | 35 Participants | 21 Participants | 14 Participants |
| Race/Ethnicity, Customized MIxed Race | 7 Participants | 1 Participants | 6 Participants |
| Race/Ethnicity, Customized unknown | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 21 Participants | 9 Participants | 12 Participants |
| Sex: Female, Male Female | 64 Participants | 31 Participants | 33 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 31 |
| other Total, other adverse events | 4 / 33 | 4 / 31 |
| serious Total, serious adverse events | 0 / 33 | 0 / 31 |
Outcome results
Primary
7-day Point Prevalence of Smoking Abstinence
The 7-day point prevalence is defined by self-reported smoking abstinence for the last 7 days.
Time frame: end of 8 weeks of treatment
Population: Participants (n=13 in TPN + Progesterone; n=9 in TPN + Placebo) missing outcome data were coded as not abstinent.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TNP + Progesterone | 7-day Point Prevalence of Smoking Abstinence | abstinent | 8 Participants |
| TNP + Progesterone | 7-day Point Prevalence of Smoking Abstinence | not abstinent | 25 Participants |
| TNP + Placebo | 7-day Point Prevalence of Smoking Abstinence | abstinent | 11 Participants |
| TNP + Placebo | 7-day Point Prevalence of Smoking Abstinence | not abstinent | 20 Participants |
p-value: 0.325395% CI: [0.1968, 1.7202]Chi-squared
Secondary
Carbon Monoxide <10 Ppm
Smoking abstinence measured by breath CO
Time frame: 3 month follow up
Population: Participants (n=14 in TPN + progesterone; n=9 in TPN + placebo) missing breath CO data were coded as \> 10 ppm (positive for smoking).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TNP + Progesterone | Carbon Monoxide <10 Ppm | CO <10 ppm | 10 Participants |
| TNP + Progesterone | Carbon Monoxide <10 Ppm | CO ≥ 10 ppm | 23 Participants |
| TNP + Placebo | Carbon Monoxide <10 Ppm | CO <10 ppm | 10 Participants |
| TNP + Placebo | Carbon Monoxide <10 Ppm | CO ≥ 10 ppm | 21 Participants |
p-value: 0.866195% CI: [0.3171, 2.6287]Chi-squared
Secondary
Carbon Monoxide <10 Ppm
Smoking abstinence measured by breath CO
Time frame: 1 month follow up
Population: Participants (n=14 in TPN + progesterone; n=9 in TPN + placebo) missing breath CO data were coded as \> 10 ppm (positive for smoking).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TNP + Progesterone | Carbon Monoxide <10 Ppm | CO <10 ppm | 6 Participants |
| TNP + Progesterone | Carbon Monoxide <10 Ppm | CO ≥ 10 ppm | 27 Participants |
| TNP + Placebo | Carbon Monoxide <10 Ppm | CO <10 ppm | 7 Participants |
| TNP + Placebo | Carbon Monoxide <10 Ppm | CO ≥ 10 ppm | 24 Participants |
p-value: 0.66295% CI: [0.2247, 2.5838]Chi-squared
Secondary
Carbon Monoxide <10 Ppm
Smoking abstinence measured by breath CO
Time frame: end of 8 weeks of treatment
Population: Participants (n=13 in TPN + Progesterone; n=10 in TPN + Placebo) missing breath CO were coded as ≥ 10 ppm (positive for smoking).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TNP + Progesterone | Carbon Monoxide <10 Ppm | CO <10 ppm | 9 Participants |
| TNP + Progesterone | Carbon Monoxide <10 Ppm | CO ≥ 10 ppm | 24 Participants |
| TNP + Placebo | Carbon Monoxide <10 Ppm | CO <10 ppm | 8 Participants |
| TNP + Placebo | Carbon Monoxide <10 Ppm | CO ≥ 10 ppm | 23 Participants |
p-value: 0.894495% CI: [0.355, 3.2744]Chi-squared
Secondary
Change in Digit Symbol Task Measure of Inhibitory Function
The Code Substitution Test (a computerized adaptation/variant of the Digit Symbol Substitution Test) is a test of psychomotor performance. The Code Substitution-Learning Throughput Score incorporates both accuracy and speed. During the learning phase of this test, users are continuously shown a row of 9 digits that are paired with a symbol (the pairings are constant). Users are presented with a series of individual pairings and are asked to press a response key to indicate if the pairing is correct or not. Quicker and more accurate responses lead to higher scores. The lowest possible score is 0 (no correct responses). There is no defined maximum score, as the score depends upon both response time and number of correct responses. A change score was calculated by subtracting baseline score from week 2 score. Higher positive scores represent greater improvement in scores at week 2 relative to baseline, and lower negative scores represent greater decline in scores from baseline to week 2.
Time frame: baseline and week 2
Population: Includes participants who completed the Code Substitution-Learning Test.at both baseline and week 2 visits.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TNP + Progesterone | Change in Digit Symbol Task Measure of Inhibitory Function | -3.95 units on a scale | Standard Deviation 11.42 |
| TNP + Placebo | Change in Digit Symbol Task Measure of Inhibitory Function | 5.32 units on a scale | Standard Deviation 11.59 |
p-value: 0.006595% CI: [2.71, 15.81]t-test, 2 sided
Secondary
Change in Go/No Go Task Measure of Inhibitory Function
Week 2 minus baseline. This task assesses the ability to withhold responses to an infrequently occurring target (No-Go trials). A total of 225 single digits (25 x 9 digits) are presented on a computer monitor for 250 ms each, immediately followed by a mask for 900 ms. Subjects must press a spacebar in response to every digit except the 3. Go/No Go score is calculated as separation between the means of the signal and the noise distributions and is reported in standard deviation units, representing an overall indicator of performance since it accounts for correct responses and incorrect responses. Higher scores represent a better outcome. For the change score, higher positive scores represent greater improvement in scores between baseline and week 2, and lower negative scores represent greater decline in scores between baseline and week 2.
Time frame: baseline and week 2
Population: Includes participants who completed the Go/No Go task at both baseline and week 2 visits.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TNP + Progesterone | Change in Go/No Go Task Measure of Inhibitory Function | 0.36 units on a scale | Standard Deviation 2.33 |
| TNP + Placebo | Change in Go/No Go Task Measure of Inhibitory Function | 0.50 units on a scale | Standard Deviation 1.45 |
p-value: 0.79195% CI: [-0.9747, 1.2707]t-test, 2 sided
Secondary
Change in Stroop Measure of Inhibitory Function
The Stroop test assesses cognitive processing. The Level 3 Stroop Throughput score incorporates both accuracy and speed. In Level 3 of the Stroop test, a series of words representing colors are shown in a font color that is incongruent with the word (e.g. RED would be shown in blue font). Users are asked to press a response key associated with the color of the font, not the written word. Quicker and more accurate responses lead to higher scores. The lowest possible score is 0 (no correct responses). There is no defined maximum score, as the score depends upon both response time and number of correct responses. A Level 3 Stroop Throughput change score was calculated by subtracting baseline score from week 2 score. Higher positive scores represent greater improvement in scores at week 2 relative to baseline, and lower negative scores represent greater decline in scores from baseline to week 2.
Time frame: baseline and week 2
Population: Includes people who completed Stroop Test at both baseline and Week 2 visits.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TNP + Progesterone | Change in Stroop Measure of Inhibitory Function | 4.1 units on a scale | Standard Deviation 24.7 |
| TNP + Placebo | Change in Stroop Measure of Inhibitory Function | -5.0 units on a scale | Standard Deviation 28.7 |
p-value: 0.3195% CI: [-27.1, 9]t-test, 2 sided
Secondary
Positive and Negative Affect Schedule (PANAS) Total Score
The PANAS questionnaire consists of 20 items that describe different feelings and emotions. Participants are asked to what extent they feel this way right now on 5-point scale ranging from 1 (very slightly or not at all) to 5 (extremely). Separate Positive Affect Scores and Negative Affect Scores were calculated from 10 items each. Scores can range from 10 t0 50, with higher scores representing higher levels of positive affect and with lower scores representing lower levels of negative affect.
Time frame: Week 8
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TNP + Progesterone | Positive and Negative Affect Schedule (PANAS) Total Score | Positive Affect Score | 25.2 score on a scale | Standard Deviation 10.4 |
| TNP + Progesterone | Positive and Negative Affect Schedule (PANAS) Total Score | Negative Affect Score | 11.6 score on a scale | Standard Deviation 2.7 |
| TNP + Placebo | Positive and Negative Affect Schedule (PANAS) Total Score | Positive Affect Score | 26.5 score on a scale | Standard Deviation 10.3 |
| TNP + Placebo | Positive and Negative Affect Schedule (PANAS) Total Score | Negative Affect Score | 10.8 score on a scale | Standard Deviation 1.5 |
Secondary
Positive and Negative Affect Schedule (PANAS) Total Score
The PANAS questionnaire consists of 20 items that describe different feelings and emotions. Participants are asked to what extent they feel this way right now on 5-point scale ranging from 1 (very slightly or not at all) to 5 (extremely). Separate Positive Affect Scores and Negative Affect Scores were calculated from 10 items each. Scores can range from 10 t0 50, with higher scores representing higher levels of positive affect and with lower scores representing lower levels of negative affect.
Time frame: 1 month follow up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TNP + Progesterone | Positive and Negative Affect Schedule (PANAS) Total Score | Positive Affect Score | 26.4 score on a scale | Standard Deviation 8.7 |
| TNP + Progesterone | Positive and Negative Affect Schedule (PANAS) Total Score | Negative Affect Score | 10.7 score on a scale | Standard Deviation 1.1 |
| TNP + Placebo | Positive and Negative Affect Schedule (PANAS) Total Score | Positive Affect Score | 26.4 score on a scale | Standard Deviation 8.7 |
| TNP + Placebo | Positive and Negative Affect Schedule (PANAS) Total Score | Negative Affect Score | 11.0 score on a scale | Standard Deviation 1.7 |
Secondary
Positive and Negative Affect Schedule (PANAS) Total Score
The PANAS questionnaire consists of 20 items that describe different feelings and emotions. Participants are asked to what extent they feel this way right now on 5-point scale ranging from 1 (very slightly or not at all) to 5 (extremely). Separate Positive Affect Scores and Negative Affect Scores were calculated from 10 items each. Scores can range from 10 t0 50, with higher scores representing higher levels of positive affect and with lower scores representing lower levels of negative affect.
Time frame: 3 month follow up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TNP + Progesterone | Positive and Negative Affect Schedule (PANAS) Total Score | Positive Affect Score | 24.8 score on a scale | Standard Deviation 7.8 |
| TNP + Progesterone | Positive and Negative Affect Schedule (PANAS) Total Score | Negative Affect Score | 11.3 score on a scale | Standard Deviation 1.6 |
| TNP + Placebo | Positive and Negative Affect Schedule (PANAS) Total Score | Positive Affect Score | 27.7 score on a scale | Standard Deviation 9.2 |
| TNP + Placebo | Positive and Negative Affect Schedule (PANAS) Total Score | Negative Affect Score | 11.1 score on a scale | Standard Deviation 1.8 |
Secondary
Positive and Negative Affect Schedule (PANAS) Total Score
The PANAS questionnaire consists of 20 items that describe different feelings and emotions. Participants are asked to what extent they feel this way right now on 5-point scale ranging from 1 (very slightly or not at all) to 5 (extremely). Separate Positive Affect Scores and Negative Affect Scores were calculated from 10 items each. Scores can range from 10 t0 50, with higher scores representing higher levels of positive affect and with lower scores representing lower levels of negative affect.
Time frame: Week 3
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TNP + Progesterone | Positive and Negative Affect Schedule (PANAS) Total Score | Positive Affect Score | 23.8 score on a scale | Standard Deviation 8.6 |
| TNP + Progesterone | Positive and Negative Affect Schedule (PANAS) Total Score | Negative Affect Score | 11.6 score on a scale | Standard Deviation 2.1 |
| TNP + Placebo | Positive and Negative Affect Schedule (PANAS) Total Score | Positive Affect Score | 27.0 score on a scale | Standard Deviation 8 |
| TNP + Placebo | Positive and Negative Affect Schedule (PANAS) Total Score | Negative Affect Score | 12.1 score on a scale | Standard Deviation 4.3 |
Secondary
Positive and Negative Affect Schedule (PANAS) Total Score
The PANAS questionnaire consists of 20 items that describe different feelings and emotions. Participants are asked to what extent they feel this way right now on 5-point scale ranging from 1 (very slightly or not at all) to 5 (extremely). Separate Positive Affect Scores and Negative Affect Scores were calculated from 10 items each. Scores can range from 10 t0 50, with higher scores representing higher levels of positive affect and with lower scores representing lower levels of negative affect.
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TNP + Progesterone | Positive and Negative Affect Schedule (PANAS) Total Score | Negative Affect Score | 11.9 score on a scale | Standard Deviation 2.1 |
| TNP + Progesterone | Positive and Negative Affect Schedule (PANAS) Total Score | Positive Affect Score | 29.2 score on a scale | Standard Deviation 7 |
| TNP + Placebo | Positive and Negative Affect Schedule (PANAS) Total Score | Positive Affect Score | 25.6 score on a scale | Standard Deviation 7.7 |
| TNP + Placebo | Positive and Negative Affect Schedule (PANAS) Total Score | Negative Affect Score | 11.4 score on a scale | Standard Deviation 1.8 |
Secondary
Positive and Negative Affect Schedule (PANAS) Total Score
The PANAS questionnaire consists of 20 items that describe different feelings and emotions. Participants are asked to what extent they feel this way right now on 5-point scale ranging from 1 (very slightly or not at all) to 5 (extremely). Separate Positive Affect Scores and Negative Affect Scores were calculated from 10 items each. Scores can range from 10 t0 50, with higher scores representing higher levels of positive affect and with lower scores representing lower levels of negative affect.
Time frame: Week 2
Population: Note: numbered analyzed does not equal 24
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TNP + Progesterone | Positive and Negative Affect Schedule (PANAS) Total Score | Positive Affect Score | 27.0 score on a scale | Standard Deviation 7.1 |
| TNP + Progesterone | Positive and Negative Affect Schedule (PANAS) Total Score | Negative Affect Score | 11.4 score on a scale | Standard Deviation 1.9 |
| TNP + Placebo | Positive and Negative Affect Schedule (PANAS) Total Score | Positive Affect Score | 24.4 score on a scale | Standard Deviation 8.3 |
| TNP + Placebo | Positive and Negative Affect Schedule (PANAS) Total Score | Negative Affect Score | 11.3 score on a scale | Standard Deviation 1.7 |
Secondary
Positive and Negative Affect Schedule (PANAS) Total Score
The PANAS questionnaire consists of 20 items that describe different feelings and emotions. Participants are asked to what extent they feel this way right now on 5-point scale ranging from 1 (very slightly or not at all) to 5 (extremely). Separate Positive Affect Scores and Negative Affect Scores were calculated from 10 items each. Scores can range from 10 t0 50, with higher scores representing higher levels of positive affect and with lower scores representing lower levels of negative affect.
Time frame: Week 4
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TNP + Progesterone | Positive and Negative Affect Schedule (PANAS) Total Score | Positive Affect Score | 28.0 score on a scale | Standard Deviation 7.4 |
| TNP + Progesterone | Positive and Negative Affect Schedule (PANAS) Total Score | Negative Affect Score | 10.6 score on a scale | Standard Deviation 1.3 |
| TNP + Placebo | Positive and Negative Affect Schedule (PANAS) Total Score | Positive Affect Score | 26.3 score on a scale | Standard Deviation 9.1 |
| TNP + Placebo | Positive and Negative Affect Schedule (PANAS) Total Score | Negative Affect Score | 11.6 score on a scale | Standard Deviation 3.3 |
Secondary
Positive and Negative Affect Schedule (PANAS) Total Score
The PANAS questionnaire consists of 20 items that describe different feelings and emotions. Participants are asked to what extent they feel this way right now on 5-point scale ranging from 1 (very slightly or not at all) to 5 (extremely). Separate Positive Affect Scores and Negative Affect Scores were calculated from 10 items each. Scores can range from 10 t0 50, with higher scores representing higher levels of positive affect and with lower scores representing lower levels of negative affect.
Time frame: Week 5
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TNP + Progesterone | Positive and Negative Affect Schedule (PANAS) Total Score | Positive Affect Score | 24.3 score on a scale | Standard Deviation 8.6 |
| TNP + Progesterone | Positive and Negative Affect Schedule (PANAS) Total Score | Negative Affect Score | 10.7 score on a scale | Standard Deviation 1 |
| TNP + Placebo | Positive and Negative Affect Schedule (PANAS) Total Score | Positive Affect Score | 27.9 score on a scale | Standard Deviation 9.1 |
| TNP + Placebo | Positive and Negative Affect Schedule (PANAS) Total Score | Negative Affect Score | 10.6 score on a scale | Standard Deviation 1.2 |
Secondary
Positive and Negative Affect Schedule (PANAS) Total Score
The PANAS questionnaire consists of 20 items that describe different feelings and emotions. Participants are asked to what extent they feel this way right now on 5-point scale ranging from 1 (very slightly or not at all) to 5 (extremely). Separate Positive Affect Scores and Negative Affect Scores were calculated from 10 items each. Scores can range from 10 t0 50, with higher scores representing higher levels of positive affect and with lower scores representing lower levels of negative affect.
Time frame: Week 6
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TNP + Progesterone | Positive and Negative Affect Schedule (PANAS) Total Score | Positive Affect Score | 25.9 score on a scale | Standard Deviation 10 |
| TNP + Progesterone | Positive and Negative Affect Schedule (PANAS) Total Score | Negative Affect Score | 10.9 score on a scale | Standard Deviation 1.8 |
| TNP + Placebo | Positive and Negative Affect Schedule (PANAS) Total Score | Positive Affect Score | 25.7 score on a scale | Standard Deviation 10 |
| TNP + Placebo | Positive and Negative Affect Schedule (PANAS) Total Score | Negative Affect Score | 11.6 score on a scale | Standard Deviation 3.3 |
Secondary
Positive and Negative Affect Schedule (PANAS) Total Score
The PANAS questionnaire consists of 20 items that describe different feelings and emotions. Participants are asked to what extent they feel this way right now on 5-point scale ranging from 1 (very slightly or not at all) to 5 (extremely). Separate Positive Affect Scores and Negative Affect Scores were calculated from 10 items each. Scores can range from 10 t0 50, with higher scores representing higher levels of positive affect and with lower scores representing lower levels of negative affect.
Time frame: Week 7
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TNP + Progesterone | Positive and Negative Affect Schedule (PANAS) Total Score | Positive Affect Score | 24.7 score on a scale | Standard Deviation 9.1 |
| TNP + Progesterone | Positive and Negative Affect Schedule (PANAS) Total Score | Negative Affect Score | 11.5 score on a scale | Standard Deviation 3.2 |
| TNP + Placebo | Positive and Negative Affect Schedule (PANAS) Total Score | Positive Affect Score | 24.7 score on a scale | Standard Deviation 9.9 |
| TNP + Placebo | Positive and Negative Affect Schedule (PANAS) Total Score | Negative Affect Score | 10.9 score on a scale | Standard Deviation 1.6 |
Secondary
Prolonged Abstinence Follow up
Abstinence from 2 weeks post quit date to 3 month follow up (total of 6-8 weeks during the trial and 3 month follow up)
Time frame: 3-month follow-up after end of treatment
Population: Participants (n=14 in TPN + progesterone; n=9 in TPN + placebo) missing breath CO data were coded as \> 10 ppm (positive for smoking).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TNP + Progesterone | Prolonged Abstinence Follow up | abstinent | 4 Participants |
| TNP + Progesterone | Prolonged Abstinence Follow up | not abstienent | 29 Participants |
| TNP + Placebo | Prolonged Abstinence Follow up | abstinent | 5 Participants |
| TNP + Placebo | Prolonged Abstinence Follow up | not abstienent | 26 Participants |
p-value: 0.644995% CI: [0.1738, 2.9594]Chi-squared
Secondary
Prolonged Abstinence Post Trial
Abstinence from 2 weeks post quit date to the one month follow up
Time frame: 1-month follow-up after end of treatment
Population: Participants (n=14 in TPN + progesterone; n=9 in TPN + placebo) missing breath CO data were coded as \> 10 ppm (positive for smoking).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TNP + Progesterone | Prolonged Abstinence Post Trial | abstinent | 4 Participants |
| TNP + Progesterone | Prolonged Abstinence Post Trial | not abstinent | 29 Participants |
| TNP + Placebo | Prolonged Abstinence Post Trial | abstinent | 5 Participants |
| TNP + Placebo | Prolonged Abstinence Post Trial | not abstinent | 26 Participants |
p-value: 0.644995% CI: [0.1738, 2.9594]Chi-squared