A Pilot Trial of Modafinil for Treatment of Methamphetamine Dependence
Patients treated for methamphetamine dependence have high rates of relapse, and no pharmacotherapy has yet been demonstrated to be efficacious. Modafinil (d, l-2-[(diphenylmethyl) sulfinyl] acetamide) is a novel wake- and vigilance- promoting agent that is chemically and pharmacologically dissimilar to CNS stimulants such as the amphetamines, methylphenidate, and pemoline. It is well tolerated and has low abuse liability compared to CNS stimulants. Modafinil is FDA approved for a variety of sleep disorders, may relieve methamphetamine withdrawal symptoms, improves cognitive function, has been shown to reduce cocaine use in dependent users, and is safe when co-administered with intravenous methamphetamine. We will conduct a pilot, open-label clinical trial of modafinil to establish its safety and efficacy as a pharmacotherapy for methamphetamine dependence.
- Determine the safety of modafinil in the treatment of methamphetamine dependence.
- Determine the efficacy of modafinil in the treatment of methamphetamine dependence.
- Assess the effect of modafinil on cognitive function in methamphetamine users.
- Assess the effect of modafinil on methamphetamine withdrawal symptoms.
- Compare the validity of a cellular telephone-based reporting system for assessing medication regimen adherence to conventional electronic medication monitoring.
- Modafinil will be as safe and well tolerated as placebo in a comparison group from another study.
- Subjects given modafinil will use less methamphetamine than subjects given placebo.
- Subjects given modafinil with demonstrate improvements in cognitive function when compared to subjects given placebo.
- Subjects given modafinil will have reduced withdrawal symptoms when compared to subjects given placebo.
- Adherence will be recorded more accurately by cellular telephone than by conventional electronic medication monitoring.
|Study Design:||Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Trial of Modafinil for Treatment of Methamphetamine Dependence|
- MA (-) urine samples [ Time Frame: multiple ] [ Designated as safety issue: No ]
|Study Start Date:||January 2008|
|Study Completion Date:||June 2011|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
400mg vs. 200mg (PO) daily
Other Name: Provigil
Please refer to this study by its ClinicalTrials.gov identifier: NCT00538655
|United States, California|
|CPMC - St. Luke's Hospital ~ 7th Floor/ Addiction Pharmacology Research Lab|
|San Francisco, California, United States, 94110|
|Principal Investigator:||Gantt Galloway, Pharm D.||California Pacific Medical Center|