A Phase 2 interventional study of modafinil in Substance Dependence and Amphetamine Dependence, sponsored by California Pacific Medical Center Research Institute. Status unknown at 1 site in United States. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2011-06-22.
Sponsored by California Pacific Medical Center Research Institute · Phase 2, Interventional, and Treatment
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.
2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.
This study's planned enrollment of 90 is below the median of 108 across 1,727 interventional studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →California Pacific Medical Center Research Institute is the lead sponsor of 39 studies on the registry; 3 are open to participants now.
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Inclusion Criteria:
Modafinil, 100mg, 400mg, or 600 mg tablets QD for 4 weeks.
Methamphetamine-negative urine samples will be analyzed using a generalized estimating equation model
Time frame: end of study
This study is status unknown, as verified in Jun 2010. You cannot join it, but the record below documents what was studied.
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California Pacific Medical Center Research Institute