A Dose Ranging Study of Modafinil for Methamphetamine Dependence

NCT ID: NCT00630097

Last Updated: 2011-06-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2011-06-30

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.

Conditions

Substance Dependence; Amphetamine Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Interventions

modafinil

Modafinil, 100mg, 400mg, or 600 mg tablets QD for 4 weeks.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age between 18 and 50 years

2. Patient is agreeable to conditions of study and signs consent form

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

California Pacific Medical Center Research Institute

OTHER

Sponsor Role: lead

Responsible Party

California Pacific Medical Center Research Institute

Principal Investigators

Gantt Galloway, PharmD

Role: PRINCIPAL_INVESTIGATOR

California Pacific Medical Center

Locations

CPMC

San Francisco, California, United States

Countries

United States

Other Identifiers

27.140

Identifier Type: -

Identifier Source: org_study_id