Effectiveness of Bupropion in Treating Marijuana Dependent Individuals

NCT ID: NCT00142870

Last Updated: 2017-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2006-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Marijuana Abuse Substance-Related Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A

Group Type PLACEBO_COMPARATOR

Bupropion

Intervention Type DRUG

150 mg, twice a day

Interventions

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Bupropion

150 mg, twice a day

Intervention Type DRUG

Other Intervention Names

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Zyban

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role lead

Responsible Party

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McLean Hospital

Principal Investigators

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David M Penetar

Role: PRINCIPAL_INVESTIGATOR

Mclean Hospital

Locations

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McLean Hospital, Dept. of Psychiatry

Belmont, Massachusetts, United States

Site Status

Countries

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United States

References

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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. Epub 2012 Jun 25.

Reference Type RESULT
PMID: 22879754 (View on PubMed)

Related Links

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Other Identifiers

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R03-17275-1

Identifier Type: -

Identifier Source: secondary_id

DPMC

Identifier Type: -

Identifier Source: secondary_id

NIDA-17275-1

Identifier Type: -

Identifier Source: org_study_id

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