Effectiveness of Bupropion in Treating Marijuana Dependent Individuals

Substance-Related Disorders Clinical Trial

Official title:

Effects of Bupropion on Marijuana Withdrawal Symptoms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00142870
• Other study ID #: NIDA-17275-1
• Secondary ID: R03-17275-1DPMC
• Status: Completed
• Phase: Phase 2
• First received: September 1, 2005
• Last updated: January 11, 2017
• Start date: March 2005
• Est. completion date: May 2006

Study information

• Verified date: October 2016
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Marijuana Abuse
• Substance-Related Disorders

Intervention

Drug:
• Bupropion
150 mg, twice a day

Locations

Country	Name	City	State
United States	McLean Hospital, Dept. of Psychiatry	Belmont	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Penetar DM, Looby AR, Ryan ET, Maywalt MA, Lukas SE. Bupropion reduces some of the symptoms of marihuana withdrawal in chronic marihuana users: a pilot study. Subst Abuse. 2012;6:63-71. doi: 10.4137/SART.S9706. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Withdrawal severity		on a daily basis for 14 days	No

External Links

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