A Randomized, Placebo-Controlled Trial of Modafinil for Methamphetamine Dependence

Phase 2

Completed

• Conditions: Methamphetamine Dependence
• Interventions: Drug: Modafinil

• Registration Number: NCT01354470
• Lead Sponsor: California Pacific Medical Center Research Institute

Brief Summary

The proposed study will establish the safety and efficacy of modafinil in the treatment of methamphetamine dependence, as well as assess the affects of modafinil on cognitive function in methamphetamine users and on methamphetamine withdrawal symptoms. In this outpatient trial, methamphetamine- dependent, treatment-seeking subjects will receive modafinil or placebo daily for four weeks, along with weekly Motivational Enhancement Therapy sessions. This study will be conducted at the Addiction \& Pharmacology Laboratory in San Francisco, CA, and at the New Leaf Treatment Center in Lafayette, CA, and is expected to last one year.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-05-12
• Study First Submitted QC: 2011-05-13
• Study First Posted: 2011-05-17
• Study Start: 2011-10
• Primary Completion: 2013-02
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-01
• Last Update Posted: 2013-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Modafinil	Modafinil	-

Primary Outcome Measures

Name	Time	Method
Urine Samples Negative for Methamphetamine	Twice weekly for 4 weeks

Trial Locations

Locations (2)

New Leaf Treatment Center; 🇺🇸 Lafayette, California, United States

CPMC Research Institute, St.Luke's Hospital; 🇺🇸 San Francisco, California, United States