Phase 2, Double-Blind, Placebo-Controlled Trial of Bupropion for Methamphetamine Dependence

NCT ID: NCT00687713

Last Updated: 2017-03-21

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2011-05-31

Brief Summary

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This study is to assess the efficacy of bupropion in reducing methamphetamine use in subjects with methamphetamine dependence who report using methamphetamine 29 or less days during the 30 days prior to the start of signing consent.

Detailed Description

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The primary objective of this study is to assess the efficacy of bupropion in reducing methamphetamine use in subjects with methamphetamine dependence who report using methamphetamine 29 or less days during the 30 days prior to signing consent. Secondary objectives included but were not limited to: assessing the success or failure to achieve abstinence (confirmed by at least two methamphetaminenegative urines and no methamphetamine-positive urines) each week during the last two weeks (Weeks 11 and 12) for subjects using methamphetamine 18 or less days during the 30 days prior to signing consent, assessing the safety of bupropion in this study population, assessing other measures of efficacy of bupropion in reducing methamphetamine use or craving, and other psychological assessments of methamphetamine dependence.

It is hypothesized that bupropion, compared to placebo, would be associated with an increase in the proportion of subjects who achieved abstinence (confirmed by at least two methamphetamine-negative urines and no methamphetaminepositive urines) each week during the last two weeks (Weeks 11 and 12) for non-daily users.

Conditions

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Methamphetamine Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Bupropion

Subjects will receive bupropion 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.

Group Type ACTIVE_COMPARATOR

Bupropion

Intervention Type DRUG

150mg for the first 3 days of dosing. Increased to 150 mg b.i.d until taper.

Placebo

Subjects will receive a matched bupropion placebo 150 mg tablet for 3 days then twice daily, for 12 weeks until dose taper during the last 3 days of week 12 at 150 mg per day.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo

Interventions

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Bupropion

150mg for the first 3 days of dosing. Increased to 150 mg b.i.d until taper.

Intervention Type DRUG

Placebo

Placebo

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Must have a DSM-IV diagnosis of methamphetamine dependence as determined by MINI
* Must have at least 1 amphetamine or methamphetamine positive urine specimen after the start of screening and before randomization or provide information to verify recent use if a positive urine sample can't be obtained
* Must report using methamphetamine for 29 days or less during the 30 day period prior signing consent using the timeline follow-back method
* Must be willing and able to comply with study procedures
* Must be able to verbalize and understand consent forms and provide written informed consent
* Must be seeking treatment for methamphetamine dependence

Exclusion Criteria

* Please contact study site for more information
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 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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Responsibility Role SPONSOR

Principal Investigators

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Jurij Mojsiak

Role: STUDY_CHAIR

National Institute on Drug Abuse (NIDA)

Locations

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UCLA Integrated Substance Abuse Program

Los Angeles, California, United States

Site Status

South Bay Treatment Center

San Diego, California, United States

Site Status

Addiction and Pharmacology Research Laboratory

San Francisco, California, United States

Site Status

Friends Research Institute

Torrance, California, United States

Site Status

Matrix Institute

Woodland Hills, California, United States

Site Status

Pacific Addiction Research Center - U of Hawaii

Honolulu, Hawaii, United States

Site Status

Iowa Luther Hospital

Des Moines, Iowa, United States

Site Status

U of Kansas Medical Center

Kansas City, Missouri, United States

Site Status

New York University

New York, New York, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

University of Texas Health Science At San Antonio

San Antonio, Texas, United States

Site Status

VA Salt Lake City Health Care System

Salt Lake City, Utah, United States

Site Status

Countries

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United States

References

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Anderson AL, Li SH, Markova D, Holmes TH, Chiang N, Kahn R, Campbell J, Dickerson DL, Galloway GP, Haning W, Roache JD, Stock C, Elkashef AM. Bupropion for the treatment of methamphetamine dependence in non-daily users: a randomized, double-blind, placebo-controlled trial. Drug Alcohol Depend. 2015 May 1;150:170-4. doi: 10.1016/j.drugalcdep.2015.01.036. Epub 2015 Feb 7.

Reference Type BACKGROUND
PMID: 25818061 (View on PubMed)

Other Identifiers

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MDS Bupropion Meth 0001

Identifier Type: -

Identifier Source: org_study_id

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