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NCT00069251 Clinical Trial

Bupropion for the Treatment of Methamphetamine Dependence - 1

Amphetamine-Related Disorders Clinical Trial

Official title:
Bupropion for the Treatment of Methamphetamine Dependence

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00069251
Other study ID # NIDA-CTO-0008-1
Secondary ID
Status Completed
Phase Phase 2
First received September 18, 2003
Last updated January 11, 2017
Start date July 2003
Est. completion date June 2005

Study information
Verified date July 2008
Source National Institute on Drug Abuse (NIDA)
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess the efficacy and safety of bupropion in reducing methamphetamine use in subjects with methamphetamine dependence

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.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date June 2005
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Bupropion

Locations
Country Name City State
United States Matrix Institute on Addictions Costa Mesa California
United States Powell Chemical Dependency Center Des Moines Iowa
United States Pacific Addiction Research Center Honolulu Hawaii
United States University of Missouri - Kansas City Kansas City Missouri
United States South Bay Treatment Center San Diego California

Sponsors (1)
Lead Sponsor Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Severity addiction
Primary Methamphetamine use
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