Methamphetamine Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled Evaluation of Bupropion vs Placebo for the Treatment of Methamphetamine Dependence
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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