Back to resultsA Dose Ranging Study of Modafinil for Methamphetamine Dependence
Primary Purpose
Substance Dependence, Amphetamine Dependence
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
modafinil
Sponsored by
About this trial
This is an interventional treatment trial for Substance Dependence focused on measuring methamphetamine addiction, meth dependence
Eligibility Criteria
Inclusion Criteria:
- Age between 18 and 50 years
- Patient is agreeable to conditions of study and signs consent form
Sites / Locations
- CPMC
Outcomes
Primary Outcome Measures
Methamphetamine-negative urine samples will be analyzed using a generalized estimating equation model
Secondary Outcome Measures
Full Information
NCT ID
NCT00630097
First Posted
February 27, 2008
Last Updated
June 21, 2011
Sponsor
California Pacific Medical Center Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT00630097
Brief Title
A Dose Ranging Study of Modafinil for Methamphetamine Dependence
Official Title
A Dose Ranging Study of Modafinil for Methamphetamine Dependence
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Unknown status
Study Start Date
December 2009 (undefined)
Primary Completion Date
June 2011 (Anticipated)
Study Completion Date
June 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
California Pacific Medical Center Research Institute
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Dependence, Amphetamine Dependence
Keywords
methamphetamine addiction, meth dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
modafinil
Intervention Description
Modafinil, 100mg, 400mg, or 600 mg tablets QD for 4 weeks.
Primary Outcome Measure Information:
Title
Methamphetamine-negative urine samples will be analyzed using a generalized estimating equation model
Time Frame
end of study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age between 18 and 50 years
Patient is agreeable to conditions of study and signs consent form
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gantt Galloway, PharmD
Organizational Affiliation
California Pacific Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
CPMC
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Dose Ranging Study of Modafinil for Methamphetamine Dependence
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