A Pilot Trial of Modafinil for Treatment of Methamphetamine Dependence

Methamphetamine Addiction Clinical Trial

Official title:

A Pilot Trial of Modafinil for Treatment of Methamphetamine Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00538655
• Other study ID #: 27.004
• Status: Completed
• Phase: Phase 2
• First received: October 2, 2007
• Last updated: May 30, 2013
• Start date: January 2008
• Est. completion date: June 2011

Study information

• Verified date: May 2013
• Source: California Pacific Medical Center Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2011
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Methamphetamine Addiction

Intervention

Drug:
• modafinil
400mg vs. 200mg (PO) daily

Locations

Country	Name	City	State
United States	CPMC - St. Luke's Hospital ~ 7th Floor/ Addiction Pharmacology Research Lab	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
California Pacific Medical Center Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MA (-) urine samples		multiple	No