Bupropion for the Treatment of Methamphetamine Dependence - 1
This study has been completed.
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00069251
First received: September 18, 2003
Last updated: July 21, 2008
Last verified: July 2008
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Purpose
The purpose of this study is to assess the efficacy and safety of bupropion in reducing methamphetamine use in subjects with methamphetamine dependence
| Condition | Intervention | Phase |
|---|---|---|
|
Amphetamine-Related Disorders |
Drug: Bupropion |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Bupropion for the Treatment of Methamphetamine Dependence |
Resource links provided by NLM:
MedlinePlus related topics:
Methamphetamine
Drug Information available for:
Methamphetamine hydrochloride
Amphetamine
Methamphetamine
Bupropion hydrochloride
Bupropion
U.S. FDA Resources
Further study details as provided by National Institute on Drug Abuse (NIDA):
Primary Outcome Measures:
- Severity addiction
- Methamphetamine use
| Estimated Enrollment: | 150 |
| Study Start Date: | July 2003 |
| Estimated Study Completion Date: | June 2005 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00069251
Locations
| United States, California | |
| Matrix Institute on Addictions | |
| Costa Mesa, California, United States, 92627 | |
| South Bay Treatment Center | |
| San Diego, California, United States, 92105 | |
| United States, Hawaii | |
| Pacific Addiction Research Center | |
| Honolulu, Hawaii, United States, 96813 | |
| United States, Iowa | |
| Powell Chemical Dependency Center | |
| Des Moines, Iowa, United States, 50316 | |
| United States, Missouri | |
| University of Missouri - Kansas City | |
| Kansas City, Missouri, United States, 64108 | |
Sponsors and Collaborators
Investigators
| Principal Investigator: | Richard Rawson, Ph.D. | University of California, Los Angeles |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00069251 History of Changes |
| Other Study ID Numbers: | NIDA-CTO-0008-1 |
| Study First Received: | September 18, 2003 |
| Last Updated: | July 21, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Amphetamine-Related Disorders Substance-Related Disorders Mental Disorders Methamphetamine Amphetamine Bupropion Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Dopamine Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses Adrenergic Agents Adrenergic Uptake Inhibitors Neurotransmitter Uptake Inhibitors Dopamine Uptake Inhibitors Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs |
ClinicalTrials.gov processed this record on May 23, 2013