Effectiveness of Bupropion in Treating Marijuana Dependent Individuals - Full Text View

Sponsor:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00142870

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Effects of Bupropion on Marijuana Withdrawal Symptoms

Resource links provided by NLM:

MedlinePlus related topics: Marijuana

Drug Information available for: Bupropion hydrochloride Bupropion

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
A: Placebo Comparator	Drug: Bupropion 150 mg, twice a day

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

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Disorders of Environmental Origin
Marijuana Abuse
Pharmacologic Actions

Mental Disorders
Therapeutic Uses
Bupropion
Substance-Related Disorders
Dopamine Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on November 27, 2009