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

California Pacific Medical Center Research Institute

Status and phase: Completed; Phase 2

Conditions: Methamphetamine Dependence

Treatments: Drug: Modafinil

Study type: Interventional

Funder types: Other

Identifiers

NCT01354470

CPMC-APRL-8B

Details and patient eligibility

About

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.

Enrollment: 72 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Age between 18 and 50 years
• Patient is agreeable to conditions of study and signs consent form

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 2 patient groups, including a placebo group

Modafinil

Experimental group

Treatment:

Drug: Modafinil

placebo (cornstarch)

Placebo Comparator group