NCT01400243

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, 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2011

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2011

Completed
11 days until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 22, 2011

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
11 months until next milestone

Results Posted

Study results publicly available

April 30, 2015

Completed
Last Updated

April 30, 2015

Status Verified

April 1, 2015

Enrollment Period

3.2 years

First QC Date

March 21, 2011

Results QC Date

February 20, 2015

Last Update Submit

April 16, 2015

Conditions

Marijuana Dependence

Keywords

MarijuanaDrug withdrawal symptomsNicotine

Outcome Measures

Primary Outcomes (3)

  • Profile of Mood Scale Total Negative Affect (Tension + Depression + Anger)

    POMS Total negative affect was assessed during the final pre-quit baseline session and the 8 post-quit sessions (1, 3, 5, 7, 9, 11, 13, and 15 days post-quit). The Total negative affect score has a minimum potential value of "0" = best possibly level and a maximum value of "154" = worst possible level.

    16 days (prequit baseline and 15 days of abstinence)

  • Marijuana Withdrawal Questionnaire (MWC) Total Score

    The Marijuana Withdrawal Questionnaire Total Score includes items assessing anxiety, depression, irritability, appetite, aggression/anger, sleep disturbance, somatic disturbances, and craving to use marijuana. The potential range of this total score is from "0" = no withdrawal symptoms to "47" = maximally high levels of withdrawal.

    16 days (prequit baseline and at 1, 3, 5, 7, 9, 11, 13, and 15 days of abstinence)

  • POMS Vigor/Positive Affect (PA)

    Profile of Mood State questionnaire Vigor/Positive Affect scale. The potential range of the Vigor/Positive Affect scale is from "0" (no vigor) to "32" (maximally high vigor score).

    16 days (baseline through day 15 of treatment)

Secondary Outcomes (6)

  • Patch Guess and Attributions Questionnaire

    Day 15 of abstinence

  • Systolic Blood Pressure (SBP)

    From baseline to Day 15 of abstinence

  • Tobacco and Nicotine Intake

    Basesline 30 days prior to study and during the 30 days following the 15-day abstinence phase.

  • Urinary Tetrahydrocannabinol (THC) Concentration in ng/ml.

    across baseline and at 3, 5, 7, 9, 11, 13, and 15 days of abstinence

  • Heart Rate

    Baseline through Day 15 of abstinence

  • +1 more secondary outcomes

Study Arms (2)

Placebo Patch

PLACEBO COMPARATOR

Placebo patch for 15-day quit period

Drug: Placebo Patch

Nicotine Patch

ACTIVE COMPARATOR

7 mg Habitrol nicotine patch-15 day quit period

Drug: Nicotine

Interventions

NicotineDRUG

Nicotine patch 7mg

Also known as: Habitrol
Nicotine Patch
Placebo PatchDRUG

Placebo patch

Also known as: Placebo patch from Rejuvenations Lab
Placebo Patch

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southern Illinois University

Carbondale, Illinois, 62901, United States

Location

Related Publications (1)

  • Gilbert DG, Rabinovich NE, McDaniel JT. Nicotine patch for cannabis withdrawal symptom relief: a randomized controlled trial. Psychopharmacology (Berl). 2020 May;237(5):1507-1519. doi: 10.1007/s00213-020-05476-1. Epub 2020 Feb 7.

    PMID: 32034447DERIVED

MeSH Terms

Conditions

Marijuana AbuseSubstance Withdrawal Syndrome

Interventions

Nicotine

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Solanaceous AlkaloidsAlkaloidsHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Limitations and Caveats

The modest sample size limited the ability to precisely characterize how the effects of patch type may be modified by tobacco smoker status, gender, personality traits, and individual differences in marijuana use history.

Results Point of Contact

Title
David G. Gilbert
Organization
Southern Illinois University Carbondale
dgilbert@siu.edu
618-453-3527

Study Officials

  • David G Gilbert, PhD

    Southern Illinois University Carbondale

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2011

First Posted

July 22, 2011

Study Start

April 1, 2011

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

April 30, 2015

Results First Posted

April 30, 2015

Record last verified: 2015-04

Locations

US(1)