Modafinil vs Placebo for the Treatment of Methamphetamine Dependence
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled Evaluation of Modafinil vs Placebo for the Treatment of Methamphetamine Dependence|
- Clean Urine Drug Screen [ Time Frame: From randomization to end of week 12 ] [ Designated as safety issue: No ]Urine samples, collected thrice weekly, were tested for metabolites of MA using radioimmunoassay. Each subject had a possible of 36 urine drug screens to provide during the 12 weeks of medication. An aggregate measure of urine drug screen results was calculated - the Treatment Effectiveness Score (TES) - which is the average of the sum of MA-free urine specimens provided during the treatment period by participants in each treatment condition.
- Retention [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]The number of persons who completed the medication phase of the trial (12 weeks of medication).
- VAS Score [ Time Frame: baseline and last observation during the 12 week treatment period ] [ Designated as safety issue: No ]To measure methamphetamine craving, mean change in craving based on visual analog scale (VAS) from 0 (not at all) to 100 (extremely) from baseline to the last week of observation during the 12 week treatment period. The last observation was carried forward if not available during week 12.
- BDI Score [ Time Frame: From baseline to end of treatment period (week 12). ] [ Designated as safety issue: No ]Self-reported depression: mean change on Beck Depression Index (BDI-II) assessed weekly during the 12 week medication phase. If the week12 measure was not available, the last observation was carried forward. 0 indicates no depression, 63 is the maximum indicating severe depression.
|Study Start Date:||April 2007|
|Study Completion Date:||January 2009|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
Active Comparator: Modafinil
Modafinil 400mg oral dose taken daily for 12 weeks
400mg pills taken orally daily for 12 wks.
Other Name: Provigil
Placebo Comparator: Placebo
Modafinil 0mg (sugar pill) oral dose taken daily for 12 weeks
400mg pills taken orally daily for 12 wks
Other Name: Sugar pill
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|United States, California|
|UCLA Vine Street Clinic|
|Hollywood, California, United States, 90038|
|Principal Investigator:||Steve Shoptaw, Ph.D.||University of California, Los Angeles|