Status:
COMPLETED
Nicotine Patch for Marijuana Withdrawal
Lead Sponsor:
Southern Illinois University Carbondale
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Marijuana Dependence
Eligibility:
All Genders
18-50 years
Phase:
PHASE4
Brief 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, doub...
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...
Eligibility Criteria
Inclusion
- 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 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.
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
127 Patients enrolled
Trial Details
Trial ID
NCT01400243
Start Date
April 1 2011
End Date
June 1 2014
Last Update
April 30 2015
Active Locations (1)
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1
Southern Illinois University
Carbondale, Illinois, United States, 62901