Effectiveness of Nefazodone and Bupropion in Treating Marijuana Dependent Individuals

This study has been completed.
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00249509
First received: November 3, 2005
Last updated: October 15, 2009
Last verified: October 2009
  Purpose

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 Intervention Phase
Marijuana Abuse
Drug: Nefazodone
Drug: Bupropion
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Marijuana Pharmacotherapies: Controlled Clinical Trials With Nefazodone and Bupropion

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Marijuana use

Secondary Outcome Measures:
  • Marijuana withdrawal

Estimated Enrollment: 132
Study Start Date: September 2000
Study Completion Date: September 2004
Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00249509

Locations
United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
Investigators
Principal Investigator: David Mcdowell, MD New York State Psychiatric Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Frances R. Levin, M.D, NYSPI
ClinicalTrials.gov Identifier: NCT00249509     History of Changes
Other Study ID Numbers: NIDA-13191-1, R01-DA013191-1, DPMC
Study First Received: November 3, 2005
Last Updated: October 15, 2009
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Marijuana Abuse
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Bupropion
Nefazodone
Antidepressive Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014