A Dose Ranging Study of Modafinil for Methamphetamine Dependence

Substance Dependence Clinical Trial

Official title:

A Dose Ranging Study of Modafinil for Methamphetamine Dependence

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00630097
• Other study ID #: 27.140
• Status: Active, not recruiting
• Phase: Phase 2
• First received: February 27, 2008
• Last updated: June 21, 2011
• Start date: December 2009
• Est. completion date: June 2011

Study information

• Verified date: June 2010
• Source: California Pacific Medical Center Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• 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. 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 coadministered with intravenous methamphetamine. We will conduct a randomized dose ranging clinical trial of modafinil to establish its safety and efficacy as a pharmacotherapy for methamphetamine dependence.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Age between 18 and 50 years

2. Patient is agreeable to conditions of study and signs consent form

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Amphetamine Dependence
• Amphetamine-Related Disorders
• Substance Dependence
• Substance-Related Disorders

Intervention

Drug:
• modafinil
Modafinil, 100mg, 400mg, or 600 mg tablets QD for 4 weeks.

Locations

Country	Name	City	State
United States	CPMC	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	Methamphetamine-negative urine samples will be analyzed using a generalized estimating equation model		end of study	No