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Nicotine for Marijuana Withdrawal (NMW)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Southern Illinois University Carbondale
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southern Illinois University Carbondale
ClinicalTrials.gov Identifier:
NCT01400243
First received: March 21, 2011
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Marijuana Dependence
Drug: Nicotine
Drug: Placebo Patch
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Southern Illinois University Carbondale:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 116
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)
Arms Assigned Interventions
Placebo Comparator: Placebo Patch
Placebo patch for 15-day quit period
Drug: Placebo Patch
Placebo patch
Other Name: Placebo patch from Rejuvenations Lab
Active Comparator: Nicotine Patch
7 mg Habitrol nicotine patch-15 day quit period
Drug: Nicotine
Nicotine patch 7mg
Other Name: Habitrol

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) 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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01400243

Contacts
Contact: Norka E Rabinovich, B.A. 618-453-3527 norkar@siu.edu
Contact: David G Gilbert, PhD 618-453-3558 dgilbert@siu.edu

Locations
United States, Illinois
Southern Illinois University Recruiting
Carbondale, Illinois, United States, 62901
Contact: Norka E Rabinovich, B.A.    618-453-3527    norkar@siu.edu   
Contact: David G Gilbert, PhD    618-453-3558    dgilbert@siu.edu   
Principal Investigator: David G Gilbert, PhD         
Sponsors and Collaborators
Southern Illinois University Carbondale
Investigators
Principal Investigator: David G Gilbert, PhD Southern Illinois University Carbondale
  More Information

No publications provided

Responsible Party: Southern Illinois University Carbondale
ClinicalTrials.gov Identifier: NCT01400243     History of Changes
Other Study ID Numbers: NIH/NIDA 1R01DA031006 - 01, R01DA031006
Study First Received: March 21, 2011
Last Updated: February 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Southern Illinois University Carbondale:
Marijuana
Drug withdrawal symptoms
Nicotine

Additional relevant MeSH terms:
Marijuana Abuse
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Nicotine
Autonomic Agents
Cholinergic Agents
Cholinergic Agonists
Ganglionic Stimulants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014