NCT00520286

Phase 2, Multi-Center Trial of Modafinil for Methamphetamine Dependence

Phase2, Double-blind, Placebo-controlled Trial of Modafinil for the Treatment of Methamphetamine Dependence

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 210 (actual)
• Sponsor: National Institute on Drug Abuse (NIDA) · NIH
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Methamphetamine Dependence

Interventions

Type	Name	Description
DRUG	Modafinil	200 mg or 400 mg /daily
DRUG	Placebo	Placebo / daily

Timeline

• Start date: 2007-12-01
• Primary completion: 2009-12-01
• Completion: 2010-03-01
• First posted: 2007-08-24
• Last updated: 2017-04-07
• Results posted: 2017-04-07

Locations

8 sites across 1 country: United States