Nicotine Patch for Marijuana Withdrawal
Condition: Marijuana Dependence
MeSH terms: Marijuana Abuse
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Nicotine; Placebo Patch
Intervention type(s): Drug; Drug
Intervention description(s): Nicotine patch 7mg; Placebo patch
Other intervention name(s): Habitrol; Placebo patch from Rejuvenations Lab
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Marijuana; Drug withdrawal symptoms; Nicotine