Effectiveness of Bupropion in Treating Marijuana Dependent Individuals
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...
Brief Summary
Official Title: “Effects of Bupropion on Marijuana Withdrawal Symptoms”
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.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
- Study Primary Completion Date: May 2006
Detailed Clinical Trial 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.
Intervention(s) in this Clinical Trial
- Drug: Bupropion
- 150 mg, twice a day
Arms, Groups and Cohorts in this Clinical Trial
- Placebo Comparator: A
Outcome Measures for this Clinical Trial
Primary Measures
- Withdrawal severity
- Time Frame: on a daily basis for 14 days
Safety Issue?: No
- Time Frame: on a daily basis for 14 days
Criteria for Participation in this Clinical Trial
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 Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 50 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: National Institute on Drug Abuse (NIDA) NIH
Overall Clinical Trial Officials and Contacts
David M Penetar Principal Investigator Mclean Hospital
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00142870
Study ID Number: NIDA-17275-1
ClinicalTrials.gov Identifier: NCT00142870
Health Authority: United States: Federal Government
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00142870
