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Effectiveness of Bupropion in Treating Marijuana Dependent Individuals

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00142870
First Posted: September 2, 2005
Last Update Posted: January 12, 2017
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.
Information provided by:
National Institute on Drug Abuse (NIDA)
  Purpose
A definable and significant withdrawal syndrome occurs upon cessation of chronic, heavy marijuana use. Bupropion (Zyban) is a medication currently used to treat withdrawal symptoms associated with tobacco use. The purpose of this study is to determine if bupropion will help individuals stop using marijuana.

Condition Intervention Phase
Marijuana Abuse Substance-Related Disorders Drug: Bupropion Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Bupropion on Marijuana Withdrawal Symptoms

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Withdrawal severity [ Time Frame: on a daily basis for 14 days ]

Enrollment: 30
Study Start Date: March 2005
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: A Drug: Bupropion
150 mg, twice a day
Other Name: Zyban

Detailed Description:

A definable and significant withdrawal syndrome occurs upon cessation of chronic, heavy marijuana use. This syndrome includes alterations in mood, sleep disturbances, and cognitive performance. Many of nicotine's withdrawal symptoms are similar to those observed with marijuana withdrawal. Bupropion has been shown to be effective in treating nicotine addiction.The purpose of this study is to determine if bupropion is effective in treating marijuana dependent individuals. Specifically, this study will determine if bupropion alleviates withdrawal symptoms associated with marijuana abuse.

Participants in this 21-day, double-blind study will be randomly assigned to receive either bupropion or placebo. Treatment with bupropion will occur for one week before stopping marijuana use (quit day). Bupropion will be administered at 150 mg per day for 3 days, followed by 300 mg per day for the remainder of the study. Quit day will occur on Day 8, at which time participants will be required to remain abstinent from marijuana for the duration of the study. Participants will provide daily urine specimens. Changes in vigilance, memory, reaction time, and psychomotor performance as well as withdrawal symptoms will be evaluated.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Current marijuana use and dependence
  • Marijuana use of at least 5 times in the past 7 days or more than 25 times per month for the 3 years prior to enrollment
  • Unsuccessful in a previous attempt to quit marijuana

Exclusion Criteria:

  • Axis I disorder
  • Any drug abuse or dependence other than marijuana
  • Currently taking antipsychotic or antidepressant medication
  • Heavy alcohol drinker (more than 20 drinks per week)
  • Current nicotine dependence
  • History of a seizure disorder
  • Current or prior eating disorder (e.g., bulimia or anorexia nervosa)
  • Heavy caffeine use (more than 300 mg per day)
  • Life threatening or unstable medical illness
  • Pregnant
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00142870


Locations
United States, Massachusetts
McLean Hospital, Dept. of Psychiatry
Belmont, Massachusetts, United States, 02478 9106
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: David M Penetar Mclean Hospital
  More Information

Additional Information:
Publications:
Responsible Party: David M. Penetar, McLean Hospital
ClinicalTrials.gov Identifier: NCT00142870     History of Changes
Other Study ID Numbers: NIDA-17275-1
R03-17275-1
DPMC
First Submitted: September 1, 2005
First Posted: September 2, 2005
Last Update Posted: January 12, 2017
Last Verified: October 2016

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

Additional relevant MeSH terms:
Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Bupropion
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


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