Effectiveness of Bupropion in Treating Marijuana Dependent Individuals
Information source: National Institute on Drug Abuse (NIDA)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Marijuana Abuse; Substance-Related Disorders
Intervention: Bupropion (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: National Institute on Drug Abuse (NIDA) Official(s) and/or principal investigator(s):
David M Penetar, Principal Investigator, Affiliation: Mclean Hospital
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.
Clinical Details
Official title: Effects of Bupropion on Marijuana Withdrawal Symptoms
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Withdrawal severity; measured at Day 21 and on a daily basis
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
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
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
Locations and Contacts
McLean Hospital, Dept. of Psychiatry, Belmont, Massachusetts 02478 9106, United States
Additional Information
Starting date: March 2005
Ending date: May 2006
Last updated: January 15, 2008
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