Marijuana Abuse Clinical Trial
Official title:
Marijuana Pharmacotherapies: Controlled Clinical Trials With Nefazodone and Bupropion
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.
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 psychiatry visits will include evaluations on
substance use behavior and overall clinical symptoms, and will last 15-30 minutes.
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