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Sponsors and Collaborators: |
National Institute on Drug Abuse (NIDA) University of California, Los Angeles |
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Information provided by: | National Institute on Drug Abuse (NIDA) |
ClinicalTrials.gov Identifier: | NCT00135785 |
Methamphetamine is an addictive stimulant drug that strongly activates certain parts of the brain. The purpose of this study is to determine the effectiveness of bupropion in combination with behavioral therapy for the treatment of methamphetamine addiction.
Condition | Intervention | Phase |
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Methamphetamine |
Drug: Bupropion Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled Evaluation of Bupropion vs Placebo for the Treatment of Methamphetamine Dependence |
Enrollment: | 73 |
Study Start Date: | October 2005 |
Study Completion Date: | May 2007 |
Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Bupropion
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Drug: Bupropion |
2: Placebo Comparator
Placebo
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Drug: Placebo |
Methamphetamine is a drug that causes excess amounts of the neurotransmitters dopamine and norepinephrine to be released into the brain. This overload produces unusual alertness and feelings of elation. When the body undergoes methamphetamine withdrawal, it experiences a reduction in dopamine and norepinephrine. Bupropion is an antidepressant used for the treatment of depression and smoking cessation. Because it functions by increasing the release of dopamine and norepinephrine in the brain, bupropion is likely to decrease the negative effects of methamphetamine withdrawal. The purpose of this study is to evaluate the efficacy of bupropion combined with contingency management (CM) and cognitive behavioral counseling (CBT) as a means of treating methamphetamine dependence.
An initial 2-week screening process will involve participants providing urine samples and completing physical and psychological assessments. If deemed eligible for the remainder of this double-blind study, participants will be randomly assigned to receive either bupropion or placebo over the course of 12 weeks. Participants in both the bupropion and placebo groups will receive contingency management and cognitive behavioral counseling. Participants will report to one of two clinical research sites three times per week. At each visit, participants will be examined by the study staff, provide a urine sample, and receive individual cognitive behavioral counseling sessions. At the end of 12 weeks, treatment will be stopped. Participants will return to the study site 30 days later for evaluation and to be assessed for any possible lingering side effects.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
Rancho Cucamonga Clinic | |
Rancho Cucamonga, California, United States, 91730 | |
UCLA Medical Center | |
Los Angeles, California, United States, 90024 |
Principal Investigator: | Steve Shoptaw, Ph.D. | University of California, Los Angeles |
Responsible Party: | UCLA Department of Family Medicine ( Dr Steven Shoptaw ) |
Study ID Numbers: | NIDA-18185-2, P50-18185-2, DPMC |
Study First Received: | August 23, 2005 |
Last Updated: | January 15, 2008 |
ClinicalTrials.gov Identifier: | NCT00135785 |
Health Authority: | United States: Federal Government |
Methamphetamine Dopamine Bupropion Amphetamine |
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Sympathomimetics Adrenergic Uptake Inhibitors Physiological Effects of Drugs Psychotropic Drugs |
Central Nervous System Stimulants Pharmacologic Actions Autonomic Agents Therapeutic Uses Dopamine Agents Peripheral Nervous System Agents Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |