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Bupropion for the Treatment of Methamphetamine Dependence - 1

Primary Purpose

Amphetamine-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
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amphetamine-Related Disorders focused on measuring amphetamine dependence

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subject must have methamphetamine dependence as determined by the DSM-IV diagnosis Subject must be willing to comply with study procedures. Ability to verbalize understanding of consent form, provide written consent, and verbalize willingness to complete study procedures Be able to comply with protocol requirements Exclusion Criteria: Please contact site for more information.

Sites / Locations

  • Matrix Institute on Addictions
  • South Bay Treatment Center
  • Pacific Addiction Research Center
  • Powell Chemical Dependency Center
  • University of Missouri - Kansas City

Outcomes

Primary Outcome Measures

Severity addiction
Methamphetamine use

Secondary Outcome Measures

Full Information

First Posted
September 18, 2003
Last Updated
January 11, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00069251
Brief Title
Bupropion for the Treatment of Methamphetamine Dependence - 1
Official Title
Bupropion for the Treatment of Methamphetamine Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2005 (undefined)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to assess the efficacy and safety of bupropion in reducing methamphetamine use in subjects with methamphetamine dependence
Detailed Description
A double-blind, placebo-controlled, parallel-group design study in which 100 subjects will be randomly assigned to placebo or bupropion for 12 weeks with follow-up assessments 4 weeks following treatment. Adaptive randomization will be used to balance treatment groups based on gender.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amphetamine-Related Disorders
Keywords
amphetamine dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
150 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Bupropion
Primary Outcome Measure Information:
Title
Severity addiction
Title
Methamphetamine use

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject must have methamphetamine dependence as determined by the DSM-IV diagnosis Subject must be willing to comply with study procedures. Ability to verbalize understanding of consent form, provide written consent, and verbalize willingness to complete study procedures Be able to comply with protocol requirements Exclusion Criteria: Please contact site for more information.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Rawson, Ph.D.
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Matrix Institute on Addictions
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92627
Country
United States
Facility Name
South Bay Treatment Center
City
San Diego
State/Province
California
ZIP/Postal Code
92105
Country
United States
Facility Name
Pacific Addiction Research Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Powell Chemical Dependency Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50316
Country
United States
Facility Name
University of Missouri - Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States

12. IPD Sharing Statement

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Bupropion for the Treatment of Methamphetamine Dependence - 1

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