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Effectiveness of Bupropion in Treating Marijuana Dependent Individuals

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ClinicalTrials.gov Identifier: NCT00142870
Recruitment Status : Completed
First Posted : September 2, 2005
Last Update Posted : January 12, 2017
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)

Tracking Information
First Submitted Date  ICMJE September 1, 2005
First Posted Date  ICMJE September 2, 2005
Last Update Posted Date January 12, 2017
Study Start Date  ICMJE March 2005
Actual Primary Completion Date May 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 3, 2008)
Withdrawal severity [ Time Frame: on a daily basis for 14 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 1, 2005)
Withdrawl severity; measured at Day 21 and on a daily basis
Change History Complete list of historical versions of study NCT00142870 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Bupropion in Treating Marijuana Dependent Individuals
Official Title  ICMJE Effects of Bupropion on Marijuana Withdrawal Symptoms
Brief Summary A definable and significant withdrawal syndrome occurs upon cessation of chronic, heavy marijuana use. Bupropion (Zyban) is a medication currently used to treat withdrawal symptoms associated with tobacco use. The purpose of this study is to determine if bupropion will help individuals stop using marijuana.
Detailed Description

A definable and significant withdrawal syndrome occurs upon cessation of chronic, heavy marijuana use. This syndrome includes alterations in mood, sleep disturbances, and cognitive performance. Many of nicotine's withdrawal symptoms are similar to those observed with marijuana withdrawal. Bupropion has been shown to be effective in treating nicotine addiction.The purpose of this study is to determine if bupropion is effective in treating marijuana dependent individuals. Specifically, this study will determine if bupropion alleviates withdrawal symptoms associated with marijuana abuse.

Participants in this 21-day, double-blind study will be randomly assigned to receive either bupropion or placebo. Treatment with bupropion will occur for one week before stopping marijuana use (quit day). Bupropion will be administered at 150 mg per day for 3 days, followed by 300 mg per day for the remainder of the study. Quit day will occur on Day 8, at which time participants will be required to remain abstinent from marijuana for the duration of the study. Participants will provide daily urine specimens. Changes in vigilance, memory, reaction time, and psychomotor performance as well as withdrawal symptoms will be evaluated.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Marijuana Abuse
  • Substance-Related Disorders
Intervention  ICMJE Drug: Bupropion
150 mg, twice a day
Other Name: Zyban
Study Arms  ICMJE Placebo Comparator: A
Intervention: Drug: Bupropion
Publications * Penetar DM, Looby AR, Ryan ET, Maywalt MA, Lukas SE. Bupropion reduces some of the symptoms of marihuana withdrawal in chronic marihuana users: a pilot study. Subst Abuse. 2012;6:63-71. doi: 10.4137/SART.S9706. Epub 2012 Jun 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 3, 2008)
30
Original Enrollment  ICMJE
 (submitted: September 1, 2005)
24
Actual Study Completion Date  ICMJE May 2006
Actual Primary Completion Date May 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Current marijuana use and dependence
  • Marijuana use of at least 5 times in the past 7 days or more than 25 times per month for the 3 years prior to enrollment
  • Unsuccessful in a previous attempt to quit marijuana

Exclusion Criteria:

  • Axis I disorder
  • Any drug abuse or dependence other than marijuana
  • Currently taking antipsychotic or antidepressant medication
  • Heavy alcohol drinker (more than 20 drinks per week)
  • Current nicotine dependence
  • History of a seizure disorder
  • Current or prior eating disorder (e.g., bulimia or anorexia nervosa)
  • Heavy caffeine use (more than 300 mg per day)
  • Life threatening or unstable medical illness
  • Pregnant
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00142870
Other Study ID Numbers  ICMJE NIDA-17275-1
R03-17275-1
DPMC
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David M. Penetar, McLean Hospital
Study Sponsor  ICMJE National Institute on Drug Abuse (NIDA)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David M Penetar Mclean Hospital
PRS Account National Institute on Drug Abuse (NIDA)
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP