A Dose Ranging Study of Modafinil for Methamphetamine Dependence

• Sponsor: California Pacific Medical Center Research Institute (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00630097
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Duration (Months): 18
• Patients Per Site Per Month: 5

Study Details

Study Description

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. 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.

Condition or Disease	Intervention/Treatment	Phase
Substance Dependence; Amphetamine Dependence	Drug: modafinil	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Dose Ranging Study of Modafinil for Methamphetamine Dependence
• Study Start Date: Dec 1, 2009
• Anticipated Primary Completion Date: Jun 1, 2011
• Anticipated Study Completion Date: Jun 1, 2011

Outcome Measures

Primary Outcome Measures

1. Methamphetamine-negative urine samples will be analyzed using a generalized estimating equation model [end of study]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Age between 18 and 50 years

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CPMC	San Francisco	California	United States	94110

Sponsors and Collaborators

• California Pacific Medical Center Research Institute

Investigators

• Principal Investigator: Gantt Galloway, PharmD, California Pacific Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00630097
• Other Study ID Numbers: 27.140
• First Posted: Mar 6, 2008
• Last Update Posted: Jun 22, 2011
• Last Verified: Jun 1, 2010

• Keywords provided by , ,: methamphetamine addiction, meth dependence
• Additional relevant MeSH terms: Substance-Related Disorders; Amphetamine-Related Disorders; Modafinil

Study Results

No Results Posted as of Jun 22, 2011