- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00069251
Bupropion for the Treatment of Methamphetamine Dependence - 1
January 11, 2017 updated by: National Institute on Drug Abuse (NIDA)
Bupropion for the Treatment of Methamphetamine Dependence
The purpose of this study is to assess the efficacy and safety of bupropion in reducing methamphetamine use in subjects with methamphetamine dependence
Study Overview
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.
Study Type
Interventional
Enrollment
150
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Costa Mesa, California, United States, 92627
- Matrix Institute on Addictions
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San Diego, California, United States, 92105
- South Bay Treatment Center
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Hawaii
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Honolulu, Hawaii, United States, 96813
- Pacific Addiction Research Center
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Iowa
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Des Moines, Iowa, United States, 50316
- Powell Chemical Dependency Center
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Missouri
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Kansas City, Missouri, United States, 64108
- University of Missouri - Kansas City
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Severity addiction
|
Methamphetamine use
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2003
Study Completion
June 1, 2005
Study Registration Dates
First Submitted
September 18, 2003
First Submitted That Met QC Criteria
September 23, 2003
First Posted (ESTIMATE)
September 24, 2003
Study Record Updates
Last Update Posted (ESTIMATE)
January 12, 2017
Last Update Submitted That Met QC Criteria
January 11, 2017
Last Verified
July 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Amphetamine-Related Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Antidepressive Agents
- Dopamine Agents
- Cytochrome P-450 Enzyme Inhibitors
- Antidepressive Agents, Second-Generation
- Cytochrome P-450 CYP2D6 Inhibitors
- Dopamine Uptake Inhibitors
- Bupropion
Other Study ID Numbers
- NIDA-CTO-0008-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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