A Dose Ranging Study of Modafinil for Methamphetamine Dependence

Status unconfirmed · Phase 2

Conditions studied: Substance Dependence, Amphetamine Dependence

In brief

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.

Key facts

Study ID

NCT00630097

Run by

California Pacific Medical Center Research Institute

People needed

90

Starts

2009-12-01

Expected to finish

2011-06-01

Last updated by the study team

2011-06-22

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

Where it is running

• CPMC — San Francisco, California, United States

Full record on ClinicalTrials.gov

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