Nicotine Patch for Marijuana Withdrawal (NMW)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
|Official Title:||Nicotine for Marijuana Withdrawal|
- Profile of Mood Scale Total Negative Affect (Tension + Depression + Anger) [ Time Frame: 16 days (prequit baseline and 15 days of abstinence) ] [ Designated as safety issue: No ]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 [ Time Frame: 16 days (prequit baseline and at 1, 3, 5, 7, 9, 11, 13, and 15 days of abstinence) ] [ Designated as safety issue: No ]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) [ Time Frame: 16 days (baseline through day 15 of treatment) ] [ Designated as safety issue: No ]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).
- Patch Guess and Attributions Questionnaire [ Time Frame: Day 15 of abstinence ] [ Designated as safety issue: No ]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.
- Systolic Blood Pressure (SBP) [ Time Frame: From baseline to Day 15 of abstinence ] [ Designated as safety issue: No ]Systolic blood pressure was measured in mmHg during each experimental session prior and subsequent to quitting marijuana.
- Tobacco and Nicotine Intake [ Time Frame: Basesline 30 days prior to study and during the 30 days following the 15-day abstinence phase. ] [ Designated as safety issue: No ]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.
- Urinary Tetrahydrocannabinol (THC) Concentration in ng/ml. [ Time Frame: across baseline and at 3, 5, 7, 9, 11, 13, and 15 days of abstinence ] [ Designated as safety issue: No ]Tetrahydrocannabinol (THC) Intake assessed by assessing urine sample creatinine corrected THC in ng/ml urine.
- Heart Rate [ Time Frame: Baseline through Day 15 of abstinence ] [ Designated as safety issue: No ]Heart rate measured during laboratory assessment sessions.
- Diastolic Blood Pressure (DBP) [ Time Frame: From baseline to Day 15 of abstinence ] [ Designated as safety issue: No ]Diastolic blood pressure measured during each of the experimental sessions-- baseline through 15-days post-quit.
|Study Start Date:||April 2011|
|Study Completion Date:||June 2014|
|Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo Patch
Placebo patch for 15-day quit period
Drug: Placebo Patch
Other Name: Placebo patch from Rejuvenations Lab
Active Comparator: Nicotine Patch
7 mg Habitrol nicotine patch-15 day quit period
Nicotine patch 7mg
Other Name: Habitrol
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01400243
|United States, Illinois|
|Southern Illinois University|
|Carbondale, Illinois, United States, 62901|
|Principal Investigator:||David G Gilbert, PhD||Southern Illinois University Carbondale|