A Pilot Trial of Modafinil for Treatment of Methamphetamine Dependence

NCT ID: NCT00538655

Last Updated: 2013-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2011-06-30

Brief Summary

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.

Conditions

Methamphetamine Addiction

Study Design

• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

modafinil

Group Type: EXPERIMENTAL

modafinil

Intervention Type: DRUG

400mg vs. 200mg (PO) daily

Interventions

modafinil

400mg vs. 200mg (PO) daily

Intervention Type: DRUG

Other Intervention Names

Provigil

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

California Pacific Medical Center Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Gantt Galloway, PharmD

Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gantt Galloway, Pharm D.

Role: PRINCIPAL_INVESTIGATOR

California Pacific Medical Center

Locations

CPMC - St. Luke's Hospital ~ 7th Floor/ Addiction Pharmacology Research Lab

San Francisco, California, United States

Countries

United States

Other Identifiers

27.004

Identifier Type: -

Identifier Source: org_study_id