Methamphetamine Dependence Clinical Trial
Official title:
Phase2, Double-blind, Placebo-controlled Trial of Modafinil for the Treatment of Methamphetamine Dependence
The purpose of this study will be to examine the safety and efficacy of modafinil in increasing number of methamphetamine non-use weeks in subjects with methamphetamine dependence.
Status | Completed |
Enrollment | 210 |
Est. completion date | March 2010 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Must be between the ages of 18 and 65 - Methamphetamine dependent as defined by DSM-IV criteria - Must be in good general heath with a history of methamphetamine use at screening - Must be able to provide written informed consent - If female and of child bearing potential, must agree to use birth control. Exclusion Criteria: - Please contact site for more information |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado Health Sciences Center | Denver | Colorado |
United States | Powell Chemical Dependency Center | Des Moines | Iowa |
United States | John A. Burns School of Medicine | Honolulu | Hawaii |
United States | START Research and Treatment | Kansas City | Missouri |
United States | Salt Lake City VA Medical Center | Salt Lake City | Utah |
United States | South Bay Treatment Center | San Diego | California |
United States | Matrix Institute on Addictions | Tarzana | California |
United States | Torrance Site | Torrance | California |
Lead Sponsor | Collaborator |
---|---|
National Institute on Drug Abuse (NIDA) | VA Office of Research and Development |
United States,
Anderson AL, Li SH, Biswas K, McSherry F, Holmes T, Iturriaga E, Kahn R, Chiang N, Beresford T, Campbell J, Haning W, Mawhinney J, McCann M, Rawson R, Stock C, Weis D, Yu E, Elkashef AM. Modafinil for the treatment of methamphetamine dependence. Drug Alco — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Abstinence | weekly | No | |
Secondary | Reduction of craving | Weekly | No |
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