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NCT00520286 Clinical Trial

Ph2 Modafinil Meth - 1

Methamphetamine Dependence Clinical Trial

Official title:
Phase2, Double-blind, Placebo-controlled Trial of Modafinil for the Treatment of Methamphetamine Dependence

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00520286
Other study ID # NIDA-CSP-1026-1
Secondary ID
Status Completed
Phase Phase 2
First received August 23, 2007
Last updated August 9, 2016
Start date December 2007
Est. completion date March 2010

Study information
Verified date August 2016
Source National Institute on Drug Abuse (NIDA)
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study will be to examine the safety and efficacy of modafinil in increasing number of methamphetamine non-use weeks in subjects with methamphetamine dependence.

Recruitment information / eligibility
Status Completed
Enrollment 210
Est. completion date March 2010
Est. primary completion date December 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Must be between the ages of 18 and 65

- Methamphetamine dependent as defined by DSM-IV criteria

- Must be in good general heath with a history of methamphetamine use at screening

- Must be able to provide written informed consent

- If female and of child bearing potential, must agree to use birth control.

Exclusion Criteria:

- Please contact site for more information

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Modafinil
200 mg or 400 mg /daily
• Placebo
Placebo / daily

Locations
Country Name City State
United States University of Colorado Health Sciences Center Denver Colorado
United States Powell Chemical Dependency Center Des Moines Iowa
United States John A. Burns School of Medicine Honolulu Hawaii
United States START Research and Treatment Kansas City Missouri
United States Salt Lake City VA Medical Center Salt Lake City Utah
United States South Bay Treatment Center San Diego California
United States Matrix Institute on Addictions Tarzana California
United States Torrance Site Torrance California

Sponsors (2)
Lead Sponsor Collaborator
National Institute on Drug Abuse (NIDA) VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

Anderson AL, Li SH, Biswas K, McSherry F, Holmes T, Iturriaga E, Kahn R, Chiang N, Beresford T, Campbell J, Haning W, Mawhinney J, McCann M, Rawson R, Stock C, Weis D, Yu E, Elkashef AM. Modafinil for the treatment of methamphetamine dependence. Drug Alco — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Abstinence weekly No
Secondary Reduction of craving Weekly No
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