Clinical Trial: Effectiveness of Nefazodone and Bupropion in Treating Marijuana Dependent Individuals

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Marijuana Pharmacotherapies: Controlled Clinical Trials With Nefazodone and Bupropion

Brief Summary: Recent research has identified the following withdrawal symptoms to be associated with abruptly stopping marijuana use: anxiety, irritability, bodily aches and pains, and difficulty sleeping. These symptoms resemble those of both depression and nicotine withdrawal, suggesting that a similar treatment drug may be useful. This study will evaluate the effectiveness of two antidepressant drugs, bupropion and nefazodone, in reducing withdrawal symptoms in marijuana dependent individuals.

Detailed Summary:

There have been few controlled studies that focus on treatments for marijuana dependence. The symptoms associated with marijuana withdrawal, including anxiety, irritability, bodily aches and pains, and difficulty sleeping, resemble those caused by depression and nicotine withdrawal. Therefore, antidepressant or nicotine withdrawal medications may be effective in treating marijuana dependence. Nefazodone and bupropion are two medications currently used to treat depression. The purpose of this study is to determine the effectiveness of nefazodone and bupropion in alleviating marijuana withdrawal symptoms. In addition, this study will evaluate whether these medications successfully treat marijuana dependent individuals in terms of treatment adherence and drug abstinence.

Participants in this double-blind trial will be randomly assigned to receive nefazodone, bupropion, or placebo. Daily doses of medication will be provided to participants in dated pill boxes; pill boxes will then be returned to the study nurse at each study visit. Medication will be taken in three daily doses; one of the doses will be a nonmedicated pill. Nefazodone will initially be given at a dose of 150 mg per day, which participants will take at bedtime. Every 5 days, the daily dose will increase by 150 mg, to a maximal dose of 600 mg of nefazodone per day. Bupropion will be given at an initial dose of 150 mg, which participants will take in the morning. After 3 days, the daily dose will increase to a total dose of 300 mg of bupropion per day.

Study visits will occur daily, at which time participants will complete drug use and withdrawal symptom reports. In addition, participants will partake in weekly therapy visits, which will consist of four sessions of motivational enhancement therapy followed by sessions of relapse prevention therapy. Bi-weekly psych
Sponsor: National Institute on Drug Abuse (NIDA)

Current Primary Outcome: Marijuana use

Original Primary Outcome: Marijuna use

Current Secondary Outcome: Marijuana withdrawal

Original Secondary Outcome: Same as current

Information By: National Institute on Drug Abuse (NIDA)

Dates:
Date Received: November 3, 2005
Date Started: September 2000
Date Completion:
Last Updated: January 13, 2017
Last Verified: March 2011