A Dose Ranging Study of Modafinil for Methamphetamine Dependence

Phase 2

• Conditions: Substance Dependence; Amphetamine Dependence

• Registration Number: NCT00630097
• Lead Sponsor: California Pacific Medical Center Research Institute

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 Description

Not available

Study Timeline

• Study First Submitted: 2008-02-27
• Study First Submitted QC: 2008-02-27
• Study First Posted: 2008-03-06
• Study Start: 2009-12
• Status Verified: 2010-06
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Last Update Submitted: 2011-06-21
• Last Update Posted: 2011-06-22

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. Age between 18 and 50 years
2. Patient is agreeable to conditions of study and signs consent form

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Methamphetamine-negative urine samples will be analyzed using a generalized estimating equation model	end of study

Trial Locations

Locations (1)

CPMC; 🇺🇸 San Francisco, California, United States