A Randomized, Placebo-Controlled Trial of Modafinil for Methamphetamine Dependence

California Pacific Medical Center Research Institute72 enrolled

Overview

The proposed study will establish the safety and efficacy of modafinil in the treatment of methamphetamine dependence, as well as assess the affects of modafinil on cognitive function in methamphetamine users and on methamphetamine withdrawal symptoms. In this outpatient trial, methamphetamine- dependent, treatment-seeking subjects will receive modafinil or placebo daily for four weeks, along with weekly Motivational Enhancement Therapy sessions. This study will be conducted at the Addiction \& Pharmacology Laboratory in San Francisco, CA, and at the New Leaf Treatment Center in Lafayette, CA, and is expected to last one year.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Methamphetamine Dependence

Interventions

600 mg Modafinil capsule

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (2)

New Leaf Treatment Center

Lafayette, California, United States

CPMC Research Institute, St.Luke's Hospital

San Francisco, California, United States

Outcomes

Primary Outcomes

Urine Samples Negative for Methamphetamine

Time frame: Twice weekly for 4 weeks

Data from ClinicalTrials.gov

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