Phase 2, Double-Blind, Placebo-Controlled Trial of Bupropion for Methamphetamine Dependence
This study has been completed.
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00687713
First received: May 29, 2008
Last updated: May 23, 2011
Last verified: May 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Methamphetamine Dependence |
Drug: Bupropion Other: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Phase 2, Double-Blind, Placebo-Controlled Trial of Bupropion for Methamphetamine Dependence |
Resource links provided by NLM:
Further study details as provided by National Institute on Drug Abuse (NIDA):
Primary Outcome Measures:
- Abstinence [ Time Frame: Weeks 11 and 12 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Overall reduction of use (sustained abstinence) [ Time Frame: 21 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | May 2008 |
| Study Completion Date: | May 2011 |
| Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: Bupropion
150mg for the first 3 days of dosing. Increased to 150 mg b.i.d until taper.
|
| Placebo Comparator: 2 |
Other: Placebo
Placebo
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00687713
Please refer to this study by its ClinicalTrials.gov identifier: NCT00687713
Locations
| United States, California | |
| UCLA Integrated Substance Abuse Program | |
| Los Angeles, California, United States, 90025 | |
| South Bay Treatment Center | |
| San Diego, California, United States, 92115 | |
| Addiction and Pharmacology Research Laboratory | |
| San Francisco, California, United States, 94110 | |
| Friends Research Institute | |
| Torrance, California, United States, 90502 | |
| Matrix Institute | |
| Woodland Hills, California, United States, 91364 | |
| United States, Hawaii | |
| Pacific Addiction Research Center - U of Hawaii | |
| Honolulu, Hawaii, United States, 96817 | |
| United States, Iowa | |
| Iowa Luther Hospital | |
| Des Moines, Iowa, United States, 50316 | |
| United States, Missouri | |
| U of Kansas Medical Center | |
| Kansas City, Missouri, United States, 64131 | |
| United States, New York | |
| New York University | |
| New York, New York, United States, 10010 | |
| United States, South Carolina | |
| Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
| United States, Texas | |
| University of Texas Health Science At San Antonio | |
| San Antonio, Texas, United States, 78229-3900 | |
| United States, Utah | |
| VA Salt Lake City Health Care System | |
| Salt Lake City, Utah, United States, 84148 | |
Sponsors and Collaborators
More Information
No publications provided
| Responsible Party: | Liza Gorgon, National Institute on Drug Abust (NIDA) |
| ClinicalTrials.gov Identifier: | NCT00687713 History of Changes |
| Other Study ID Numbers: | MDS Bupropion Meth 0001 |
| Study First Received: | May 29, 2008 |
| Last Updated: | May 23, 2011 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Bupropion Antidepressive Agents Antidepressive Agents, Second-Generation Central Nervous System Agents Dopamine Agents Dopamine Uptake Inhibitors Molecular Mechanisms of Pharmacological Action |
Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Pharmacologic Actions Physiological Effects of Drugs Psychotropic Drugs Therapeutic Uses |
ClinicalTrials.gov processed this record on March 01, 2015