Effectiveness of Nefazodone and Bupropion in Treating Marijuana Dependent Individuals

January 13, 2017 updated by: National Institute on Drug Abuse (NIDA)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment

132

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • New York State Psychiatric Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Marijuana use

Secondary Outcome Measures

Outcome Measure
Marijuana withdrawal

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: David Mcdowell, MD, New York State Psychiatric Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2000

Primary Completion (Actual)

September 1, 2004

Study Completion (Actual)

September 1, 2004

Study Registration Dates

First Submitted

November 3, 2005

First Submitted That Met QC Criteria

November 3, 2005

First Posted (Estimate)

November 7, 2005

Study Record Updates

Last Update Posted (Estimate)

January 16, 2017

Last Update Submitted That Met QC Criteria

January 13, 2017

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDA-13191-1
  • DPMC (Other Identifier: NIDA)
  • R01-DA013191-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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