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Effectiveness of Bupropion in Treating Marijuana Dependent Individuals

This study has been completed.
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00142870
First received: September 1, 2005
Last updated: September 3, 2008
Last verified: September 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Marijuana Abuse
Substance-Related Disorders
 Drug: Bupropion
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Bupropion on Marijuana Withdrawal Symptoms

Resource links provided by NLM:

MedlinePlus related topics: Marijuana
U.S. FDA Resources

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Withdrawal severity [ Time Frame: on a daily basis for 14 days ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: March 2005
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: A Drug: Bupropion
150 mg, twice a day
Other Name: Zyban

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.

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00142870

Locations
United States, Massachusetts
McLean Hospital, Dept. of Psychiatry
Belmont, Massachusetts, United States, 02478 9106
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: David M Penetar Mclean Hospital
  More Information

No publications provided

Responsible Party: David M. Penetar, McLean Hospital
ClinicalTrials.gov Identifier: NCT00142870     History of Changes
Other Study ID Numbers: NIDA-17275-1, R03-17275-1, DPMC
Study First Received: September 1, 2005
Last Updated: September 3, 2008
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Marijuana Abuse
Substance-Related Disorders
Mental Disorders
Bupropion
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
 Therapeutic Uses
Pharmacologic Actions
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013