Nicotine Patch for Marijuana Withdrawal
Condition: Marijuana Dependence
MeSH terms: Marijuana Abuse
Intervention: Nicotine; Placebo Patch
Intervention description: Nicotine patch 7mg; Placebo patch
Intervention MeSH terms: Nicotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 127.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Marijuana; Drug withdrawal symptoms; Nicotine

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.
    

Eligibility criteria:

        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.