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Phase 4 N=127 Randomized Double-blind Basic Science

Nicotine Patch for Marijuana Withdrawal

Marijuana Dependence

Enrolled (actual)
127
Serious AEs
0.0%
Results posted
Apr 2015
Primary outcome: Primary: Profile of Mood Scale Total Negative Affect (Tension + Depression + Anger) — 8.52; 8.096; 5.14; 4.615 units on a scale

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Nicotine (Drug); Placebo Patch (Drug)
Age
Adult · 18+ yrs
Sex
All
Sponsor
Southern Illinois University Carbondale
Primary completion
Jun 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
Profile of Mood Scale Total Negative Affect (Tension + Depression + Anger)
8.52; 8.096; 5.14; 4.615; 6.73; 7.48
PRIMARY
Marijuana Withdrawal Questionnaire (MWC) Total Score
4.29; 3.67; 3.80; 4.35; 5.16; 7.12
PRIMARY
POMS Vigor/Positive Affect (PA)
12.45; 11.18; 12.97; 10.72; 13.82; 12.34
SECONDARY
Patch Guess and Attributions Questionnaire
49.23; 59.85
SECONDARY
Systolic Blood Pressure (SBP)
115.31; 113.48; 119.42; 115.21; 120.85; 115.00
SECONDARY
Tobacco and Nicotine Intake
5.47; 7.75; 0.23; 6.66
SECONDARY
Urinary Tetrahydrocannabinol (THC) Concentration in ng/ml.
343.35; 400.84; 102.16; 128.49; 61.02; 73.07 .05
SECONDARY
Heart Rate
65.44; 67.86; 69.54; 65.98; 73.0; 68.80 <0.05 sig
SECONDARY
Diastolic Blood Pressure (DBP)
65.06; 68.05; 69.94; 68.32; 72.60; 67.88

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01400243). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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