NCT00630097

A Dose Ranging Study of Modafinil for Methamphetamine Dependence

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: California Pacific Medical Center Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Substance Dependence
• Amphetamine Dependence

Interventions

Type	Name	Description
DRUG	modafinil	Modafinil, 100mg, 400mg, or 600 mg tablets QD for 4 weeks.

Timeline

• Start date: 2009-12-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2008-03-06
• Last updated: 2011-06-22

Locations

1 site across 1 country: United States