Phase 2, Multi-Center Trial of Modafinil for Methamphetamine Dependence
- Registration Number
- NCT00520286
- Lead Sponsor
- National Institute on Drug Abuse (NIDA)
- Brief Summary
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.
- Detailed Description
To evaluate the efficacy and safety of modafinil in reducing methamphetamine use in subjects with methamphetamine dependence. It is hypothesized that modafinil, compared to placebo, will be associated with an increase in the number of methamphetamine non-use weeks over time as measured by quantitative urine analysis for methamphetamine.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 210
- 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.
- Please contact site for more information
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants will receive a matching Modafinil placebo 200 mg or 400 mg tablet one time per day for 12 weeks Modafinil Modafinil Participants will receive a Modafinil 200 mg or 400 mg tablet one time per day for 12 weeks
- Primary Outcome Measures
Name Time Method Abstinence (Week 1 - 12) Weeks 1 - 12 Number of participant who abstained from methamphetamine from weeks 1 through 12
- Secondary Outcome Measures
Name Time Method Reduction of Craving 21 days Number of subjects with 21 or more consecutive days of abstinence
Trial Locations
- Locations (8)
Powell Chemical Dependency Center
🇺🇸Des Moines, Iowa, United States
Matrix Institute on Addictions
🇺🇸Tarzana, California, United States
University of Colorado Health Sciences Center
🇺🇸Denver, Colorado, United States
South Bay Treatment Center
🇺🇸San Diego, California, United States
Torrance Site
🇺🇸Torrance, California, United States
Salt Lake City VA Medical Center
🇺🇸Salt Lake City, Utah, United States
John A. Burns School of Medicine
🇺🇸Honolulu, Hawaii, United States
START Research and Treatment
🇺🇸Kansas City, Missouri, United States