Modafinil vs Placebo for the Treatment of Methamphetamine Dependence
Status:
Completed
Trial end date:
2009-01-01
Target enrollment:
Participant gender:
Summary
Modafinil is a non-amphetamine type stimulant that acts as a wakefulness-promoting drug, and
is approved for managing symptoms of narcolepsy (i.e., daytime somnolence). Its precise
mechanism of action in promoting wakefulness remains unclear. This trial is a
placebo-controlled double-blind trial of modafinil, on a platform of contingency management
(CM) and individual cognitive-behavioral (CBT) counseling, for the treatment of
methamphetamine dependence. Participants in this study will complete a 2-week baseline
screening period during which they will provide urine samples and complete physical and
psychological assessments to establish their eligibility for the study. In addition,
participants will be asked to provide a blood or saliva specimen for genetic testing in order
to identify genetic variations that influence response to methamphetamine and to treatment
with modafinil. Upon successful completion of screening, participants will be randomly
assigned to receive either modafinil (400mg qd) or placebo during the 12 weeks of the study.
Neither the participants nor study staff will know who is receiving active medication or
placebo. Regardless of medication condition, all participants will receive CM and weekly
individual CBT counseling sessions to help them stop using methamphetamine and prevent
relapse. They will attend the clinical research site (either at the UCLA Hollywood Clinic, or
the Rancho Cucamonga site) three times per week, providing urine samples at each visit,
completing data measures, and receiving individual CBT counseling on one visit each week. At
the end of the 12-week study, the medication or placebo will be discontinued. Participants
will return to the research site approximately 30 days following medication discontinuation
for a brief health check to assess any possible lingering side effects and complete brief
data measures.