Clinical Trial: A Dose Ranging Study of Modafinil for Methamphetamine Dependence

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Dose Ranging Study of Modafinil for Methamphetamine Dependence

Brief Summary: 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. 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 coadministered with intravenous methamphetamine. We will conduct a randomized dose ranging clinical trial of modafinil to establish its safety and efficacy as a pharmacotherapy for methamphetamine dependence.

Detailed Summary:
Sponsor: California Pacific Medical Center Research Institute

Current Primary Outcome: Methamphetamine-negative urine samples will be analyzed using a generalized estimating equation model [ Time Frame: end of study ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: California Pacific Medical Center Research Institute

Dates:
Date Received: February 27, 2008
Date Started: December 2009
Date Completion: June 2011
Last Updated: June 21, 2011
Last Verified: June 2010