Effectiveness of Bupropion in Treating Marijuana Dependent Individuals - Tabular View

Tracking Information

First Received Date ^ICMJE

September 1, 2005

Last Updated Date

September 3, 2008

Start Date ^ICMJE

March 2005

Primary Completion Date

May 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

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 Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Marijuana Abuse
Substance-Related Disorders

Intervention ^ICMJE

Drug: Bupropion

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

May 2006

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

Gender

Both

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00142870

Responsible Party

David M. Penetar, McLean Hospital

Study ID Numbers ^ICMJE

NIDA-17275-1, R03-17275-1, DPMC

Study Sponsor ^ICMJE

National Institute on Drug Abuse (NIDA)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

David M Penetar

Mclean Hospital

Information Provided By

National Institute on Drug Abuse (NIDA)

Verification Date

September 2008

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