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Effectiveness of Bupropion in Treating Marijuana Dependent Individuals

Primary Purpose

Marijuana Abuse, Substance-Related Disorders

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bupropion
Sponsored by
National Institute on Drug Abuse (NIDA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Marijuana Abuse focused on measuring marijuana, treatment

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • McLean Hospital, Dept. of Psychiatry

Arms of the Study

Arm 1

Arm Type

Placebo Comparator

Arm Label

A

Arm Description

Outcomes

Primary Outcome Measures

Withdrawal severity

Secondary Outcome Measures

Full Information

First Posted
September 1, 2005
Last Updated
January 11, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00142870
Brief Title
Effectiveness of Bupropion in Treating Marijuana Dependent Individuals
Official Title
Effects of Bupropion on Marijuana Withdrawal Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
May 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Marijuana Abuse, Substance-Related Disorders
Keywords
marijuana, treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Bupropion
Other Intervention Name(s)
Zyban
Intervention Description
150 mg, twice a day
Primary Outcome Measure Information:
Title
Withdrawal severity
Time Frame
on a daily basis for 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David M Penetar
Organizational Affiliation
Mclean Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
McLean Hospital, Dept. of Psychiatry
City
Belmont
State/Province
Massachusetts
ZIP/Postal Code
02478 9106
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22879754
Citation
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.
Results Reference
result
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed/22879754
Description
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Effectiveness of Bupropion in Treating Marijuana Dependent Individuals

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