Effectiveness of Nefazodone and Bupropion in Treating Marijuana Dependent Individuals

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00249509
Recruitment Status : Completed
First Posted : November 7, 2005
Last Update Posted : January 16, 2017
Information provided by:
National Institute on Drug Abuse (NIDA)

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.

Condition or disease Intervention/treatment Phase
Marijuana Abuse Drug: Nefazodone Drug: Bupropion Phase 2

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Marijuana Pharmacotherapies: Controlled Clinical Trials With Nefazodone and Bupropion
Study Start Date : September 2000
Actual Primary Completion Date : September 2004
Actual Study Completion Date : September 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana
U.S. FDA Resources

Primary Outcome Measures :
  1. Marijuana use

Secondary Outcome Measures :
  1. Marijuana withdrawal

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Meets DSM-IV criteria for current marijuana dependence
  • Uses at least 5 marijuana joints per week
  • Currently seeking treatment for marijuana dependence
  • Used marijuana in a maladaptive pattern in the 6 months prior to study entry

Exclusion Criteria:

  • History of seizures or unexplained loss of consciousness
  • Significant and unstable psychiatric condition (e.g., schizophrenia, bipolar disorder)
  • Chronic organic mental disorder
  • Dependent on any substances of abuse other than marijuana
  • Currently at significant suicidal risk
  • Unstable physical disorder that may represent a severe untreated condition, such as hypertension (blood pressure greater than 150/90), elevated transaminase levels, or unstable diabetes
  • Current or suspected coronary vascular disease
  • Has taken a monoamine oxidase inhibitor in the 2 weeks prior to study entry
  • Currently taking terfenedine, cisapride, astemizole, or pimozide
  • History of an allergic reaction to bupropion or nefazodone
  • If female, pregnant, breastfeeding, or unwilling to use an adequate method of contraception for the duration of the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00249509

United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Principal Investigator: David Mcdowell, MD New York State Psychiatric Institute

Additional Information:
Responsible Party: Frances R. Levin, M.D, NYSPI Identifier: NCT00249509     History of Changes
Other Study ID Numbers: NIDA-13191-1
First Posted: November 7, 2005    Key Record Dates
Last Update Posted: January 16, 2017
Last Verified: March 2011

Keywords provided by National Institute on Drug Abuse (NIDA):
marijuana dependence

Additional relevant MeSH terms:
Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors