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

National Institutes of Health (NIH)

Status and phase: Completed; Phase 2

Conditions: Methamphetamine Dependence

Treatments: Drug: Modafinil; Drug: Placebo

Study type: Interventional

Funder types: Other U.S. Federal agency; NIH

Identifiers

NCT00520286

NIDA-CSP-1026-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 210 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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210 participants in 2 patient groups, including a placebo group

Modafinil

Active Comparator group

Description:

Participants will receive a Modafinil 200 mg or 400 mg tablet one time per day for 12 weeks

Treatment:

Drug: Modafinil

Placebo

Placebo Comparator group

Description:

Participants will receive a matching Modafinil placebo 200 mg or 400 mg tablet one time per day for 12 weeks

Treatment:

Drug: Placebo