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A Dose Ranging Study of Modafinil for Methamphetamine Dependence

Information source: California Pacific Medical Center Research Institute
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Substance Dependence; Amphetamine Dependence

Intervention: modafinil (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: California Pacific Medical Center Research Institute

Official(s) and/or principal investigator(s):
Gantt Galloway, PharmD, 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. 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.

Clinical Details

Official title: A Dose Ranging Study of Modafinil for Methamphetamine Dependence

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Methamphetamine-negative urine samples will be analyzed using a generalized estimating equation model

Eligibility

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

Criteria:

Inclusion Criteria: 1. Age between 18 and 50 years 2. Patient is agreeable to conditions of study and signs consent form

Locations and Contacts

CPMC, San Francisco, California 94110, United States
Additional Information

Starting date: December 2009
Last updated: June 21, 2011

Page last updated: August 20, 2015

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