Nicotine 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: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
|Official Title:||Nicotine for Marijuana Withdrawal|
- Marijuana withdrawal symptoms (mood, use, and urge to use marijuana) [ Time Frame: 15 days ] [ Designated as safety issue: No ]These dependent variables will be assessed with the following previously validated and reliable measures during the 4 pre-quit and 8 post-quit sessions: Marijuana Withdrawal Checklist, Marijuana Craving Questionnaire, Brief Symptom Inventory Sleep Inventory, Wisconsin Smoking Withdrawal Scale, Center for Epidemiological Studies-Depression Scale, and Profile of Mood States (POMS). The baseline and one-month follow-up assessments will allow the detection of any treatment-associated increases or decreases in marijuana, nicotine and other drug use.
- Patch Guess and Attributions Questionnaire [ Time Frame: 15 days ] [ 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 and attributed effects of the patch on the individual's cognition, affect, and behavior.
- Blood Pressure [ Time Frame: 15 days ] [ Designated as safety issue: No ]Blood pressure will be measured.
- Tobacco dependence. [ Time Frame: 52 days ] [ Designated as safety issue: No ]Self-reported frequency of nicotine/tobacco use and level of dependence will also be assessed one month after the end of treatment with the nicotine/tobacco timeline followback method. Expired breath carbon monoxide concentration will also be assessed during each pre-follow-up session to assess smoking.
- Tobacco and nicotine intake [ Time Frame: 52 days ] [ Designated as safety issue: No ]Nicotine intake will be assessed by: 1) self-reported tobacco and other nicotine intake, and 2) urinary concentration of cotinine, the major metabolite of nicotine during pre-treatment and treatment phase. Self-reported frequency of nicotine/tobacco use and level of dependence will also be assessed one month after the end of treatment with the nicotine/tobacco timeline followback method.
- Body Weight [ Time Frame: 22 days ] [ Designated as safety issue: No ]Body weight will be assessed during baseline and treatment phases.
- THC Intake [ Time Frame: 22 days ] [ Designated as safety issue: No ]THC intake will be assessed during the baseline and treatment phases.
- Heart Rate [ Time Frame: 15 days ] [ Designated as safety issue: No ]Heart rate will be measured.
|Study Start Date:||April 2011|
|Estimated Study Completion Date:||July 2014|
|Estimated 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) 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
|Contact: Norka E Rabinovich, B.A.||email@example.com|
|Contact: David G Gilbert, PhDfirstname.lastname@example.org|
|United States, Illinois|
|Southern Illinois University||Recruiting|
|Carbondale, Illinois, United States, 62901|
|Contact: Norka E Rabinovich, B.A. 618-453-3527 email@example.com|
|Contact: David G Gilbert, PhD 618-453-3558 firstname.lastname@example.org|
|Principal Investigator: David G Gilbert, PhD|
|Principal Investigator:||David G Gilbert, PhD||Southern Illinois University Carbondale|