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

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.

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Key information

Conditions

Methamphetamine Dependence

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

New Leaf Treatment Center, Lafayette, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Modafinil

Drug

600 mg Modafinil capsule

Primary outcomes

Urine Samples Negative for Methamphetamine

Time frame: Twice weekly for 4 weeks

Sponsors and collaborators

Lead sponsor

California Pacific Medical Center Research Institute

Other

Registry information

Important dates

Study start: 2011
Primary completion: 2013
First posted: May 17, 2011
Registry last updated: Jul 2, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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