A Pilot Trial of Modafinil for Treatment of Methamphetamine Dependence

California Pacific Medical Center Research Institute

Status and phase: Completed; Phase 2

Conditions: Methamphetamine Addiction

Treatments: Drug: modafinil

Study type: Interventional

Funder types: Other

Identifiers

NCT00538655

27.004

Details and patient eligibility

About

Patients treated for methamphetamine dependence have high rates of relapse, and no pharmacotherapy has yet been demonstrated to be efficacious. Modafinil (d, l-2-[(diphenylmethyl) sulfinyl] acetamide) is a novel wake- and vigilance- promoting agent that is chemically and pharmacologically dissimilar to CNS stimulants such as the amphetamines, methylphenidate, and pemoline. It is well tolerated and has low abuse liability compared to CNS stimulants. Modafinil is FDA approved for a variety of sleep disorders, may relieve methamphetamine withdrawal symptoms, improves cognitive function, has been shown to reduce cocaine use in dependent users, and is safe when co-administered with intravenous methamphetamine. We will conduct a pilot, open-label clinical trial of modafinil to establish its safety and efficacy as a pharmacotherapy for methamphetamine dependence.

Specific Aims:

1. Determine the safety of modafinil in the treatment of methamphetamine dependence.
2. Determine the efficacy of modafinil in the treatment of methamphetamine dependence.
3. Assess the effect of modafinil on cognitive function in methamphetamine users.
4. Assess the effect of modafinil on methamphetamine withdrawal symptoms.
5. Compare the validity of a cellular telephone-based reporting system for assessing medication regimen adherence to conventional electronic medication monitoring.

Hypotheses:

1. Modafinil will be as safe and well tolerated as placebo in a comparison group from another study.
2. Subjects given modafinil will use less methamphetamine than subjects given placebo.
3. Subjects given modafinil with demonstrate improvements in cognitive function when compared to subjects given placebo.
4. Subjects given modafinil will have reduced withdrawal symptoms when compared to subjects given placebo.
5. Adherence will be recorded more accurately by cellular telephone than by conventional electronic medication monitoring.

Enrollment: 20 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
• Fluency in English

Contact site for additional information.

Trial design

20 participants in 1 patient group

modafinil

Experimental group

Treatment:

Drug: modafinil