Marijuana Dependence
Conditions
Keywords
Marijuana, Drug withdrawal symptoms, Nicotine
Brief summary
The purpose of this 3-year trial is to test the efficacy of transdermal nicotine patch versus placebo patch on marijuana withdrawal symptoms in cannabis-dependent individuals, using a randomized, double-blind, and placebo-controlled design. This proposal is in response to RFA-DA-10-016(R01) Medications Development for Cannabis-Related Disorders. Consistent with the goals of this RFA, the overall goal of the proposed project is to assess the impact of transdermal nicotine patch (TNP) on marijuana (MJ) withdrawal (negative affect and craving motivated by negative affect) symptoms in MJ-dependent individuals.
Detailed description
The aim of this proposal is to accurately assess the effects of TNP on MJ withdrawal symptoms across 15 days of biochemically confirmed MJ abstinence using a placebo-controlled, double-blind, randomly assigned treatment design, while closely monitoring any potential adverse effects, including changes in nicotine use and dependence. To achieve these goals, 116 carefully screened cannabis-dependent individuals (58 female) will be randomly assigned to one of two doses (0 mg or 7mg nicotine) of TNP (transdermal nicotine patch) while they abstain from MJ for 15 days. Subjects will be administered a follow-up phone interview 30 days after the termination of treatment to assess the effects of nicotine-patch treatment on: 1) frequency of nicotine and tobacco smoking intake, 2) Fagerstrom Test of Nicotine Dependence (FTND)-assessed nicotine dependence, 3) new use of nicotine during the time since completion of the study, and 4) marijuana and other drug use patterns. Large financial contingencies will be used to provide a high degree of abstinence and study completion. This will be the first adequately powered study to assess the effects of TNP on MJ negative affect-related withdrawal symptoms and urges to use MJ. Withdrawal patterns and abstinence will be assessed in two groups of MJ-dependent individuals: 1) those who rarely or never smoke tobacco, and 2) those who smoke four or fewer tobacco cigarettes per day (very-light tobacco smokers). A stratified randomization method will be used to control for gender and tobacco-smoker status. It is hypothesized that MJ withdrawal symptoms will be less severe in the group assigned to the 7 mg patch than in the group assigned to the placebo. It is also hypothesized that individuals high in anxiety/neuroticism and those high in aggression/hostility will exhibit greater benefits from TNP than those low in these traits. Given that no gender differences were observed in our preliminary study, gender differences are not predicted. The over-the-counter availability, minimal abuse risks, and minimal adverse side-effects associated with TNP would make it an ideal and highly implementable treatment for MJ dependence if it can be demonstrated to be efficacious in reducing MJ withdrawal symptoms.
Interventions
DRUGNicotine
Nicotine patch 7mg
DRUGPlacebo Patch
Placebo patch
Sponsors
National Institute on Drug Abuse (NIDA)
Southern Illinois University Carbondale
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
Female and male cannabis-dependent MJ smokers aged 18 years or older will be recruited. Inclusion criteria include cannabis dependence as assessed by a Diagnostic and Statistical Manual (DSM-IV)-based structured interview and MJ use on 10-28 occasions per week and be willing to abstain for 15 days. Only individuals who are in good mental and physical health, with a BMI of 17-30 kg/m2, as verified by health questionnaires and the Structured Clinical Interview for DSM-IV (SCID), will participate in this study. Potential subjects will be asked to indicate, on a scale of 1-10, how strong they currently want to quit smoking MJ (from 1 = not at all to 10 = very strong) and will also be assessed with the four-item MJ Stages of Change. Additionally, subjects will fulfill one of two criteria: 1) not smoke or use other tobacco products or 2) smoke tobacco cigarettes or use other nicotine delivery systems (e.g., hookah, cigars, chewing tobacco) fewer than 5 times per day (on average) for the past year. Current use of MJ and tobacco will be verified by detectable urine Tetrahydrocannabinol (THC) and nicotine metabolites. All subjects will be required to provide four pre-quit baseline urine samples. The mean creatinine-normalized THC concentration across these samples must be of 175 ng/ml or greater based. -
Exclusion criteria
Criteria include meeting DSM-IV criteria for current abuse or dependence on a substance other than MJ, nicotine, or caffeine, using psychoactive substances (other than MJ, alcohol, nicotine, & caffeine) 6+ times/month, testing positive for stimulants, antidepressants, anxiolytics, and/or opiates (10-panel urine drug test), testing above a salivary cotinine concentration of 150 ng/ml during the initial screening, using creatinine or creatinine-containing supplements, testing positive for adulteration of urine samples, consuming more than 6 alcoholic drinks per day continuously for a month, mental disorders including bipolar disorder, schizophrenia, psychotic symptoms, currently, recently, or ever chronically at significant suicidal risk or experiencing violent thoughts or current major depression. Others that will be excluded include women who are pregnant, lactating, not taking precautions to avoid pregnancy, individuals with significant physical disorders or unstable physical disorders that may represent a severe untreated condition, such as hypertension, as well as those with less than a high school education or equivalent, primary language other than English, and those with significant cognitive impairment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Profile of Mood Scale Total Negative Affect (Tension + Depression + Anger) | 16 days (prequit baseline and 15 days of abstinence) | POMS Total negative affect was assessed during the final pre-quit baseline session and the 8 post-quit sessions (1, 3, 5, 7, 9, 11, 13, and 15 days post-quit). The Total negative affect score has a minimum potential value of 0 = best possibly level and a maximum value of 154 = worst possible level. |
| Marijuana Withdrawal Questionnaire (MWC) Total Score | 16 days (prequit baseline and at 1, 3, 5, 7, 9, 11, 13, and 15 days of abstinence) | The Marijuana Withdrawal Questionnaire Total Score includes items assessing anxiety, depression, irritability, appetite, aggression/anger, sleep disturbance, somatic disturbances, and craving to use marijuana. The potential range of this total score is from 0 = no withdrawal symptoms to 47 = maximally high levels of withdrawal. |
| POMS Vigor/Positive Affect (PA) | 16 days (baseline through day 15 of treatment) | Profile of Mood State questionnaire Vigor/Positive Affect scale. The potential range of the Vigor/Positive Affect scale is from 0 (no vigor) to 32 (maximally high vigor score). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urinary Tetrahydrocannabinol (THC) Concentration in ng/ml. | across baseline and at 3, 5, 7, 9, 11, 13, and 15 days of abstinence | Tetrahydrocannabinol (THC) Intake assessed by assessing urine sample creatinine corrected THC in ng/ml urine. |
| Patch Guess and Attributions Questionnaire | Day 15 of abstinence | The Patch Guess and Attributions Questionnaire assesses which type of patch (active versus placebo) the subject believes that he or she was given during the study. This assessment was made at end of treatment (Day 15 of abstinence), the last day on a patch. Scores range from 0 percent to 100 percent chance of being on the nicotine patch for those actually on the placebo patch and from 0 percent to 100 percent chance of being on the nicotine patch for those subjects actually on the nicotine patch. Each subject was asked to indicate the percentage chance that he or she was on the nicotine (as opposed to the placebo) patch. The mean values reported below are the group mean percentage averages. |
| Diastolic Blood Pressure (DBP) | From baseline to Day 15 of abstinence | Diastolic blood pressure measured during each of the experimental sessions-- baseline through 15-days post-quit. |
| Heart Rate | Baseline through Day 15 of abstinence | Heart rate measured during laboratory assessment sessions. |
| Systolic Blood Pressure (SBP) | From baseline to Day 15 of abstinence | Systolic blood pressure was measured in mmHg during each experimental session prior and subsequent to quitting marijuana. |
| Tobacco and Nicotine Intake | Basesline 30 days prior to study and during the 30 days following the 15-day abstinence phase. | Nicotine intake was assessed by self-reported tobacco cigarettes per month (30 days) at baseline (prior to treatment) and also across the 30 days starting immediately after the end of treatment. |
Countries
United States
Participant flow
Recruitment details
Female and male cannabis-dependent individuals 18 years or older were recruited by flyers and advertisements in newspapers to participate in the study in the locally well-know Southern Illinois University Integrative Neuroscience Laboratory and Smoking Lab.
Pre-assignment details
During four sessions across three weeks prior to quitting the use of marijuana, subjects completed questionnaires that assessed mood, drug use, urge to use marijuana (MJ), questionnaires, and motivation to quit MJ, and provided urine, saliva, and expired breath samples for the level of marijuana and other drug use level.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Patch Placebo patch for 15-day quit period
Placebo Patch: Placebo patch | 64 |
| Nicotine Patch 7 mg Habitrol nicotine patch-15 day quit period
Nicotine: Nicotine patch 7mg | 63 |
| Total | 127 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 8 | 11 |
Baseline characteristics
| Characteristic | Placebo Patch | Nicotine Patch | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 64 Participants | 63 Participants | 127 Participants |
| Age, Continuous Age | 20.57 years STANDARD_DEVIATION 2.43 | 21.19 years STANDARD_DEVIATION 3.86 | 20.87 years STANDARD_DEVIATION 3.2 |
| Region of Enrollment United States | 64 participants | 63 participants | 127 participants |
| Sex: Female, Male Female | 22 Participants | 16 Participants | 38 Participants |
| Sex: Female, Male Male | 42 Participants | 47 Participants | 89 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 41 / 63 | 40 / 64 |
| serious Total, serious adverse events | 0 / 63 | 0 / 64 |
Outcome results
Primary
Marijuana Withdrawal Questionnaire (MWC) Total Score
The Marijuana Withdrawal Questionnaire Total Score includes items assessing anxiety, depression, irritability, appetite, aggression/anger, sleep disturbance, somatic disturbances, and craving to use marijuana. The potential range of this total score is from 0 = no withdrawal symptoms to 47 = maximally high levels of withdrawal.
Time frame: 16 days (prequit baseline and at 1, 3, 5, 7, 9, 11, 13, and 15 days of abstinence)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Patch | Marijuana Withdrawal Questionnaire (MWC) Total Score | Post-Quit Day 1 MWC | 3.80 units on a scale | Standard Error 0.53 |
| Placebo Patch | Marijuana Withdrawal Questionnaire (MWC) Total Score | Post-Quit Day 9 MWC | 5.64 units on a scale | Standard Error 0.75 |
| Placebo Patch | Marijuana Withdrawal Questionnaire (MWC) Total Score | Post-Quit Day 5 MWC | 5.79 units on a scale | Standard Error 0.8 |
| Placebo Patch | Marijuana Withdrawal Questionnaire (MWC) Total Score | Post-Quit Day 11 MWC | 5.27 units on a scale | Standard Error 0.81 |
| Placebo Patch | Marijuana Withdrawal Questionnaire (MWC) Total Score | Post-Quit Day 3 MWC | 5.16 units on a scale | Standard Error 0.75 |
| Placebo Patch | Marijuana Withdrawal Questionnaire (MWC) Total Score | Post-Quit Day 13 MWC | 5.48 units on a scale | Standard Error 0.76 |
| Placebo Patch | Marijuana Withdrawal Questionnaire (MWC) Total Score | Post-Quit Day 7 MWC | 6.30 units on a scale | Standard Error 0.84 |
| Placebo Patch | Marijuana Withdrawal Questionnaire (MWC) Total Score | Post-Quit Day 15 MWC | 5.11 units on a scale | Standard Error 0.66 |
| Placebo Patch | Marijuana Withdrawal Questionnaire (MWC) Total Score | Pre-Quit Baseline MWC | 4.29 units on a scale | Standard Error 0.59 |
| Nicotine Patch | Marijuana Withdrawal Questionnaire (MWC) Total Score | Post-Quit Day 15 MWC | 5.02 units on a scale | Standard Error 0.68 |
| Nicotine Patch | Marijuana Withdrawal Questionnaire (MWC) Total Score | Pre-Quit Baseline MWC | 3.67 units on a scale | Standard Error 0.61 |
| Nicotine Patch | Marijuana Withdrawal Questionnaire (MWC) Total Score | Post-Quit Day 1 MWC | 4.35 units on a scale | Standard Error 0.55 |
| Nicotine Patch | Marijuana Withdrawal Questionnaire (MWC) Total Score | Post-Quit Day 3 MWC | 7.12 units on a scale | Standard Error 0.78 |
| Nicotine Patch | Marijuana Withdrawal Questionnaire (MWC) Total Score | Post-Quit Day 5 MWC | 7.02 units on a scale | Standard Error 0.83 |
| Nicotine Patch | Marijuana Withdrawal Questionnaire (MWC) Total Score | Post-Quit Day 7 MWC | 6.98 units on a scale | Standard Error 0.88 |
| Nicotine Patch | Marijuana Withdrawal Questionnaire (MWC) Total Score | Post-Quit Day 9 MWC | 6.04 units on a scale | Standard Error 0.78 |
| Nicotine Patch | Marijuana Withdrawal Questionnaire (MWC) Total Score | Post-Quit Day 11 MWC | 6.56 units on a scale | Standard Error 0.84 |
| Nicotine Patch | Marijuana Withdrawal Questionnaire (MWC) Total Score | Post-Quit Day 13 MWC | 5.23 units on a scale | Standard Error 0.79 |
Primary
POMS Vigor/Positive Affect (PA)
Profile of Mood State questionnaire Vigor/Positive Affect scale. The potential range of the Vigor/Positive Affect scale is from 0 (no vigor) to 32 (maximally high vigor score).
Time frame: 16 days (baseline through day 15 of treatment)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Patch | POMS Vigor/Positive Affect (PA) | Post-Quit Day 13 Vigor/PA | 14.43 units on a scale | Standard Error 0.85 |
| Placebo Patch | POMS Vigor/Positive Affect (PA) | Pre-Quit Baseline Vigor/PA | 12.45 units on a scale | Standard Error 0.82 |
| Placebo Patch | POMS Vigor/Positive Affect (PA) | Post-Quit Day 1 Vigor/PA | 12.97 units on a scale | Standard Error 0.87 |
| Placebo Patch | POMS Vigor/Positive Affect (PA) | Post-Quit Day 3 Vigor/PA | 13.82 units on a scale | Standard Error 0.86 |
| Placebo Patch | POMS Vigor/Positive Affect (PA) | Post-Quit Day 5 Vigor/PA | 14.19 units on a scale | Standard Error 0.84 |
| Placebo Patch | POMS Vigor/Positive Affect (PA) | Post-Quit Day 7 Vigor/PA | 14.40 units on a scale | Standard Error 0.9 |
| Placebo Patch | POMS Vigor/Positive Affect (PA) | Post-Quit Day 9 Vigor/PA | 14.59 units on a scale | Standard Error 0.91 |
| Placebo Patch | POMS Vigor/Positive Affect (PA) | Post-Quit Day 11 Vigor/PA | 14.51 units on a scale | Standard Error 0.85 |
| Placebo Patch | POMS Vigor/Positive Affect (PA) | Post-Quit Day 15 Vigor/PA | 15.37 units on a scale | Standard Error 0.88 |
| Nicotine Patch | POMS Vigor/Positive Affect (PA) | Post-Quit Day 11 Vigor/PA | 11.94 units on a scale | Standard Error 0.82 |
| Nicotine Patch | POMS Vigor/Positive Affect (PA) | Post-Quit Day 7 Vigor/PA | 11.94 units on a scale | Standard Error 0.86 |
| Nicotine Patch | POMS Vigor/Positive Affect (PA) | Pre-Quit Baseline Vigor/PA | 11.18 units on a scale | Standard Error 0.79 |
| Nicotine Patch | POMS Vigor/Positive Affect (PA) | Post-Quit Day 13 Vigor/PA | 12.54 units on a scale | Standard Error 0.82 |
| Nicotine Patch | POMS Vigor/Positive Affect (PA) | Post-Quit Day 1 Vigor/PA | 10.72 units on a scale | Standard Error 0.84 |
| Nicotine Patch | POMS Vigor/Positive Affect (PA) | Post-Quit Day 9 Vigor/PA | 12.52 units on a scale | Standard Error 0.88 |
| Nicotine Patch | POMS Vigor/Positive Affect (PA) | Post-Quit Day 3 Vigor/PA | 12.34 units on a scale | Standard Error 0.83 |
| Nicotine Patch | POMS Vigor/Positive Affect (PA) | Post-Quit Day 15 Vigor/PA | 12.15 units on a scale | Standard Error 0.85 |
| Nicotine Patch | POMS Vigor/Positive Affect (PA) | Post-Quit Day 5 Vigor/PA | 12.35 units on a scale | Standard Error 0.81 |
Primary
Profile of Mood Scale Total Negative Affect (Tension + Depression + Anger)
POMS Total negative affect was assessed during the final pre-quit baseline session and the 8 post-quit sessions (1, 3, 5, 7, 9, 11, 13, and 15 days post-quit). The Total negative affect score has a minimum potential value of 0 = best possibly level and a maximum value of 154 = worst possible level.
Time frame: 16 days (prequit baseline and 15 days of abstinence)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Patch | Profile of Mood Scale Total Negative Affect (Tension + Depression + Anger) | Post-Quit Day 1 POMS Total Negative | 5.14 units on a scale | Standard Error 1.66 |
| Placebo Patch | Profile of Mood Scale Total Negative Affect (Tension + Depression + Anger) | Post-Quit Day 9 POMS Total Negative | 7.36 units on a scale | Standard Error 1.74 |
| Placebo Patch | Profile of Mood Scale Total Negative Affect (Tension + Depression + Anger) | Post-Quit Day 5 POMS Total Negative | 7.86 units on a scale | Standard Error 1.52 |
| Placebo Patch | Profile of Mood Scale Total Negative Affect (Tension + Depression + Anger) | Post-Quit Day 11 POMS Total Negative | 8.30 units on a scale | Standard Error 1.92 |
| Placebo Patch | Profile of Mood Scale Total Negative Affect (Tension + Depression + Anger) | Post-Quit Day 3 POMS Total Negative | 6.73 units on a scale | Standard Error 1.67 |
| Placebo Patch | Profile of Mood Scale Total Negative Affect (Tension + Depression + Anger) | Post-Quit Day 13 POMS Total Negative | 6.66 units on a scale | Standard Error 1.64 |
| Placebo Patch | Profile of Mood Scale Total Negative Affect (Tension + Depression + Anger) | Post-Quit Day 7 POMS Total Negative | 10.34 units on a scale | Standard Error 2.45 |
| Placebo Patch | Profile of Mood Scale Total Negative Affect (Tension + Depression + Anger) | Post-Quit Day 15 POMS Total Negative | 6.61 units on a scale | Standard Error 1.73 |
| Placebo Patch | Profile of Mood Scale Total Negative Affect (Tension + Depression + Anger) | Baseline POMS Total Negative | 8.52 units on a scale | Standard Error 1.48 |
| Nicotine Patch | Profile of Mood Scale Total Negative Affect (Tension + Depression + Anger) | Post-Quit Day 15 POMS Total Negative | 5.10 units on a scale | Standard Error 1.8 |
| Nicotine Patch | Profile of Mood Scale Total Negative Affect (Tension + Depression + Anger) | Baseline POMS Total Negative | 8.096 units on a scale | Standard Error 1.54 |
| Nicotine Patch | Profile of Mood Scale Total Negative Affect (Tension + Depression + Anger) | Post-Quit Day 1 POMS Total Negative | 4.615 units on a scale | Standard Error 1.72 |
| Nicotine Patch | Profile of Mood Scale Total Negative Affect (Tension + Depression + Anger) | Post-Quit Day 3 POMS Total Negative | 7.48 units on a scale | Standard Error 1.73 |
| Nicotine Patch | Profile of Mood Scale Total Negative Affect (Tension + Depression + Anger) | Post-Quit Day 5 POMS Total Negative | 6.62 units on a scale | Standard Error 1.58 |
| Nicotine Patch | Profile of Mood Scale Total Negative Affect (Tension + Depression + Anger) | Post-Quit Day 7 POMS Total Negative | 8.60 units on a scale | Standard Error 2.54 |
| Nicotine Patch | Profile of Mood Scale Total Negative Affect (Tension + Depression + Anger) | Post-Quit Day 9 POMS Total Negative | 6.87 units on a scale | Standard Error 1.8 |
| Nicotine Patch | Profile of Mood Scale Total Negative Affect (Tension + Depression + Anger) | Post-Quit Day 11 POMS Total Negative | 7.23 units on a scale | Standard Error 1.99 |
| Nicotine Patch | Profile of Mood Scale Total Negative Affect (Tension + Depression + Anger) | Post-Quit Day 13 POMS Total Negative | 5.31 units on a scale | Standard Error 1.71 |
Secondary
Diastolic Blood Pressure (DBP)
Diastolic blood pressure measured during each of the experimental sessions-- baseline through 15-days post-quit.
Time frame: From baseline to Day 15 of abstinence
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Patch | Diastolic Blood Pressure (DBP) | Post-Quit Day 1 DBP | 69.94 mm Hg | Standard Error 1.07 |
| Placebo Patch | Diastolic Blood Pressure (DBP) | Post-Quit Day 9 DBP | 70.54 mm Hg | Standard Error 1.08 |
| Placebo Patch | Diastolic Blood Pressure (DBP) | Post-Quit Day 5 DBP | 73.02 mm Hg | Standard Error 1.21 |
| Placebo Patch | Diastolic Blood Pressure (DBP) | Post-Quit Day 11 DBP | 72.50 mm Hg | Standard Error 1.17 |
| Placebo Patch | Diastolic Blood Pressure (DBP) | Post-Quit Day 3 DBP | 72.60 mm Hg | Standard Error 1.28 |
| Placebo Patch | Diastolic Blood Pressure (DBP) | Post-Quit Day 13 DBP | 71.19 mm Hg | Standard Error 1.21 |
| Placebo Patch | Diastolic Blood Pressure (DBP) | Post-Quit Day 7 DBP | 71.62 mm Hg | Standard Error 1.25 |
| Placebo Patch | Diastolic Blood Pressure (DBP) | Post-Quit Day 15 DBP | 72.75 mm Hg | Standard Error 1.32 |
| Placebo Patch | Diastolic Blood Pressure (DBP) | Pre-Quit Baseline DBP | 65.06 mm Hg | Standard Error 1.27 |
| Nicotine Patch | Diastolic Blood Pressure (DBP) | Post-Quit Day 15 DBP | 69.55 mm Hg | Standard Error 1.27 |
| Nicotine Patch | Diastolic Blood Pressure (DBP) | Pre-Quit Baseline DBP | 68.05 mm Hg | Standard Error 1.23 |
| Nicotine Patch | Diastolic Blood Pressure (DBP) | Post-Quit Day 1 DBP | 68.32 mm Hg | Standard Error 1.03 |
| Nicotine Patch | Diastolic Blood Pressure (DBP) | Post-Quit Day 3 DBP | 67.88 mm Hg | Standard Error 1.24 |
| Nicotine Patch | Diastolic Blood Pressure (DBP) | Post-Quit Day 5 DBP | 69.46 mm Hg | Standard Error 1.17 |
| Nicotine Patch | Diastolic Blood Pressure (DBP) | Post-Quit Day 7 DBP | 68.52 mm Hg | Standard Error 1.21 |
| Nicotine Patch | Diastolic Blood Pressure (DBP) | Post-Quit Day 9 DBP | 69.29 mm Hg | Standard Error 1.04 |
| Nicotine Patch | Diastolic Blood Pressure (DBP) | Post-Quit Day 11 DBP | 71.57 mm Hg | Standard Error 1.13 |
| Nicotine Patch | Diastolic Blood Pressure (DBP) | Post-Quit Day 13 DBP | 70.98 mm Hg | Standard Error 1.17 |
Secondary
Heart Rate
Heart rate measured during laboratory assessment sessions.
Time frame: Baseline through Day 15 of abstinence
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Patch | Heart Rate | Post-Quit Day 9 Heart Rate | 75.83 beats per minute | Standard Error 1.67 |
| Placebo Patch | Heart Rate | Pre-Quit Baseline Heart Rate | 65.44 beats per minute | Standard Error 1.47 |
| Placebo Patch | Heart Rate | Post-Quit Day 1 Heart Rate | 69.54 beats per minute | Standard Error 1.46 |
| Placebo Patch | Heart Rate | Post-Quit Day 3 Heart Rate | 73.0 beats per minute | Standard Error 1.6 |
| Placebo Patch | Heart Rate | Post-Quit Day 5 Heart Rate | 73.25 beats per minute | Standard Error 1.71 |
| Placebo Patch | Heart Rate | Post-Quit Day 7 Heart Rate | 74.04 beats per minute | Standard Error 1.65 |
| Placebo Patch | Heart Rate | Post-Quit Day 11 Heart Rate | 73.02 beats per minute | Standard Error 1.84 |
| Placebo Patch | Heart Rate | Post-Quit Day 13 Heart Rate | 75.42 beats per minute | Standard Error 1.64 |
| Placebo Patch | Heart Rate | Post-Quit Day 15 Heart Rate | 72.50 beats per minute | Standard Error 1.58 |
| Nicotine Patch | Heart Rate | Post-Quit Day 15 Heart Rate | 70.64 beats per minute | Standard Error 1.52 |
| Nicotine Patch | Heart Rate | Post-Quit Day 7 Heart Rate | 67.34 beats per minute | Standard Error 1.59 |
| Nicotine Patch | Heart Rate | Pre-Quit Baseline Heart Rate | 67.86 beats per minute | Standard Error 1.42 |
| Nicotine Patch | Heart Rate | Post-Quit Day 9 Heart Rate | 69.36 beats per minute | Standard Error 1.61 |
| Nicotine Patch | Heart Rate | Post-Quit Day 1 Heart Rate | 65.98 beats per minute | Standard Error 1.4 |
| Nicotine Patch | Heart Rate | Post-Quit Day 13 Heart Rate | 69.88 beats per minute | Standard Error 1.58 |
| Nicotine Patch | Heart Rate | Post-Quit Day 3 Heart Rate | 68.80 beats per minute | Standard Error 1.54 |
| Nicotine Patch | Heart Rate | Post-Quit Day 11 Heart Rate | 70.89 beats per minute | Standard Error 1.78 |
| Nicotine Patch | Heart Rate | Post-Quit Day 5 Heart Rate | 67.91 beats per minute | Standard Error 1.65 |
p-value: <0.05ANOVA
Secondary
Patch Guess and Attributions Questionnaire
The Patch Guess and Attributions Questionnaire assesses which type of patch (active versus placebo) the subject believes that he or she was given during the study. This assessment was made at end of treatment (Day 15 of abstinence), the last day on a patch. Scores range from 0 percent to 100 percent chance of being on the nicotine patch for those actually on the placebo patch and from 0 percent to 100 percent chance of being on the nicotine patch for those subjects actually on the nicotine patch. Each subject was asked to indicate the percentage chance that he or she was on the nicotine (as opposed to the placebo) patch. The mean values reported below are the group mean percentage averages.
Time frame: Day 15 of abstinence
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Patch | Patch Guess and Attributions Questionnaire | 49.23 Percentage chance on nicotine patch | Standard Error 4.23 |
| Nicotine Patch | Patch Guess and Attributions Questionnaire | 59.85 Percentage chance on nicotine patch | Standard Error 3.59 |
Secondary
Systolic Blood Pressure (SBP)
Systolic blood pressure was measured in mmHg during each experimental session prior and subsequent to quitting marijuana.
Time frame: From baseline to Day 15 of abstinence
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Patch | Systolic Blood Pressure (SBP) | Quit-Day 1 SBP | 119.42 mmHg | Standard Error 1.82 |
| Placebo Patch | Systolic Blood Pressure (SBP) | Quit-Day 9 SBP | 118.50 mmHg | Standard Error 1.75 |
| Placebo Patch | Systolic Blood Pressure (SBP) | Quit-Day 5 SBP | 120.25 mmHg | Standard Error 1.82 |
| Placebo Patch | Systolic Blood Pressure (SBP) | Quit-Day 11 SBP | 120.21 mmHg | Standard Error 1.85 |
| Placebo Patch | Systolic Blood Pressure (SBP) | Quit-Day 3 SBP | 120.85 mmHg | Standard Error 1.74 |
| Placebo Patch | Systolic Blood Pressure (SBP) | Quit-Day 13 SBP | 120.58 mmHg | Standard Error 1.68 |
| Placebo Patch | Systolic Blood Pressure (SBP) | Quit-Day 7 SBP | 121.02 mmHg | Standard Error 1.91 |
| Placebo Patch | Systolic Blood Pressure (SBP) | Quit-Day 15 SBP | 120.69 mmHg | Standard Error 1.78 |
| Placebo Patch | Systolic Blood Pressure (SBP) | Pre-Quit Baseline SBP | 115.31 mmHg | Standard Error 1.72 |
| Nicotine Patch | Systolic Blood Pressure (SBP) | Quit-Day 15 SBP | 115.07 mmHg | Standard Error 1.71 |
| Nicotine Patch | Systolic Blood Pressure (SBP) | Pre-Quit Baseline SBP | 113.48 mmHg | Standard Error 1.66 |
| Nicotine Patch | Systolic Blood Pressure (SBP) | Quit-Day 1 SBP | 115.21 mmHg | Standard Error 1.75 |
| Nicotine Patch | Systolic Blood Pressure (SBP) | Quit-Day 3 SBP | 115.00 mmHg | Standard Error 1.68 |
| Nicotine Patch | Systolic Blood Pressure (SBP) | Quit-Day 5 SBP | 117.64 mmHg | Standard Error 1.75 |
| Nicotine Patch | Systolic Blood Pressure (SBP) | Quit-Day 7 SBP | 115.77 mmHg | Standard Error 1.84 |
| Nicotine Patch | Systolic Blood Pressure (SBP) | Quit-Day 9 SBP | 116.73 mmHg | Standard Error 1.69 |
| Nicotine Patch | Systolic Blood Pressure (SBP) | Quit-Day 11 SBP | 115.80 mmHg | Standard Error 1.79 |
| Nicotine Patch | Systolic Blood Pressure (SBP) | Quit-Day 13 SBP | 115.63 mmHg | Standard Error 1.62 |
Secondary
Tobacco and Nicotine Intake
Nicotine intake was assessed by self-reported tobacco cigarettes per month (30 days) at baseline (prior to treatment) and also across the 30 days starting immediately after the end of treatment.
Time frame: Basesline 30 days prior to study and during the 30 days following the 15-day abstinence phase.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Patch | Tobacco and Nicotine Intake | Pre-Treatment Tobacco/Week | 5.47 Cigarettes per 30 days | Standard Error 3.28 |
| Placebo Patch | Tobacco and Nicotine Intake | Post-Treatment Tobacco/Week | 0.23 Cigarettes per 30 days | Standard Error 3.87 |
| Nicotine Patch | Tobacco and Nicotine Intake | Pre-Treatment Tobacco/Week | 7.75 Cigarettes per 30 days | Standard Error 3.13 |
| Nicotine Patch | Tobacco and Nicotine Intake | Post-Treatment Tobacco/Week | 6.66 Cigarettes per 30 days | Standard Error 3.7 |
Secondary
Urinary Tetrahydrocannabinol (THC) Concentration in ng/ml.
Tetrahydrocannabinol (THC) Intake assessed by assessing urine sample creatinine corrected THC in ng/ml urine.
Time frame: across baseline and at 3, 5, 7, 9, 11, 13, and 15 days of abstinence
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Patch | Urinary Tetrahydrocannabinol (THC) Concentration in ng/ml. | Pre-Quit Baseline THC | 343.35 ng/ml urine creatinine-corrected THC | Standard Error 78.4 |
| Placebo Patch | Urinary Tetrahydrocannabinol (THC) Concentration in ng/ml. | Post-Quit Day 3 THC | 102.16 ng/ml urine creatinine-corrected THC | Standard Error 20.43 |
| Placebo Patch | Urinary Tetrahydrocannabinol (THC) Concentration in ng/ml. | Post-Quit Day 5 THC | 61.02 ng/ml urine creatinine-corrected THC | Standard Error 9.17 |
| Placebo Patch | Urinary Tetrahydrocannabinol (THC) Concentration in ng/ml. | Post-Quit Day 7 THC | 43.86 ng/ml urine creatinine-corrected THC | Standard Error 6.28 |
| Placebo Patch | Urinary Tetrahydrocannabinol (THC) Concentration in ng/ml. | Post-Quit Day 9 THC | 32.61 ng/ml urine creatinine-corrected THC | Standard Error 4.35 |
| Placebo Patch | Urinary Tetrahydrocannabinol (THC) Concentration in ng/ml. | Post-Quit Day 11 THC | 26.27 ng/ml urine creatinine-corrected THC | Standard Error 3.95 |
| Placebo Patch | Urinary Tetrahydrocannabinol (THC) Concentration in ng/ml. | Post-Quit Day 13 THC | 20.04 ng/ml urine creatinine-corrected THC | Standard Error 2.94 |
| Placebo Patch | Urinary Tetrahydrocannabinol (THC) Concentration in ng/ml. | Post-Quit Day 15 THC | 19.97 ng/ml urine creatinine-corrected THC | Standard Error 2.88 |
| Nicotine Patch | Urinary Tetrahydrocannabinol (THC) Concentration in ng/ml. | Post-Quit Day 15 THC | 23.70 ng/ml urine creatinine-corrected THC | Standard Error 2.78 |
| Nicotine Patch | Urinary Tetrahydrocannabinol (THC) Concentration in ng/ml. | Pre-Quit Baseline THC | 400.84 ng/ml urine creatinine-corrected THC | Standard Error 75.55 |
| Nicotine Patch | Urinary Tetrahydrocannabinol (THC) Concentration in ng/ml. | Post-Quit Day 9 THC | 38.25 ng/ml urine creatinine-corrected THC | Standard Error 4.19 |
| Nicotine Patch | Urinary Tetrahydrocannabinol (THC) Concentration in ng/ml. | Post-Quit Day 3 THC | 128.49 ng/ml urine creatinine-corrected THC | Standard Error 19.68 |
| Nicotine Patch | Urinary Tetrahydrocannabinol (THC) Concentration in ng/ml. | Post-Quit Day 13 THC | 27.35 ng/ml urine creatinine-corrected THC | Standard Error 2.82 |
| Nicotine Patch | Urinary Tetrahydrocannabinol (THC) Concentration in ng/ml. | Post-Quit Day 5 THC | 73.07 ng/ml urine creatinine-corrected THC | Standard Error 8.83 |
| Nicotine Patch | Urinary Tetrahydrocannabinol (THC) Concentration in ng/ml. | Post-Quit Day 11 THC | 33.31 ng/ml urine creatinine-corrected THC | Standard Error 3.81 |
| Nicotine Patch | Urinary Tetrahydrocannabinol (THC) Concentration in ng/ml. | Post-Quit Day 7 THC | 54.45 ng/ml urine creatinine-corrected THC | Standard Error 6.05 |
p-value: 0.05ANCOVA