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A Pilot Trial of Modafinil for Treatment of Methamphetamine Dependence

Information source: California Pacific Medical Center Research Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Methamphetamine Addiction

Intervention: modafinil (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: California Pacific Medical Center Research Institute

Official(s) and/or principal investigator(s):
Gantt Galloway, Pharm D., Principal Investigator, Affiliation: California Pacific Medical Center

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 such as the amphetamines, methylphenidate, and pemoline. 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 co-administered with intravenous methamphetamine. We will conduct a pilot, open-label clinical trial of modafinil to establish its safety and efficacy as a pharmacotherapy for methamphetamine dependence. Specific Aims: 1. Determine the safety of modafinil in the treatment of methamphetamine dependence. 2. Determine the efficacy of modafinil in the treatment of methamphetamine dependence. 3. Assess the effect of modafinil on cognitive function in methamphetamine users. 4. Assess the effect of modafinil on methamphetamine withdrawal symptoms. 5. Compare the validity of a cellular telephone-based reporting system for assessing medication regimen adherence to conventional electronic medication monitoring. Hypotheses: 1. Modafinil will be as safe and well tolerated as placebo in a comparison group from another study. 2. Subjects given modafinil will use less methamphetamine than subjects given placebo. 3. Subjects given modafinil with demonstrate improvements in cognitive function when compared to subjects given placebo. 4. Subjects given modafinil will have reduced withdrawal symptoms when compared to subjects given placebo. 5. Adherence will be recorded more accurately by cellular telephone than by conventional electronic medication monitoring.

Clinical Details

Official title: A Pilot Trial of Modafinil for Treatment of Methamphetamine Dependence

Study design: Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: MA (-) urine samples

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Age between 18 and 50 years

- Patient is agreeable to conditions of study and signs consent form

- Fluency in English

Contact site for additional information.

Locations and Contacts

CPMC - St. Luke's Hospital ~ 7th Floor/ Addiction Pharmacology Research Lab, San Francisco, California 94110, United States
Additional Information

Starting date: January 2008
Last updated: May 30, 2013

Page last updated: August 23, 2015

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