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Safety and Tolerability of Modafinil for Methamphetmaine Dependence
This study has been completed.
Study NCT00569374   Information provided by University of Arkansas
First Received: December 5, 2007   Last Updated: December 3, 2008   History of Changes

December 5, 2007
December 3, 2008
September 2007
September 2008   (final data collection date for primary outcome measure)
Safety and tolerability of modafinil in methamphetamine-dependent persons [ Time Frame: 7 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00569374 on ClinicalTrials.gov Archive Site
Treatment retention and illicit drug use [ Time Frame: 7 weeks ] [ Designated as safety issue: Yes ]
Same as current
 
Safety and Tolerability of Modafinil for Methamphetmaine Dependence
Safety and Tolerability of Modafinil for Methamphetamine Dependence

This 7 week, open-label pilot clinical trial will examine the safety and tolerability of modafinil up to 400mg/day as a potential treatment to reduce methamphetamine use in methamphetamine-dependent volunteers.

 
Phase II
Interventional
Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Methamphetamine Dependence
Drug: Modafinil
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
8
 
September 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18-65 years old
  • not currently enrolled in a treatment program
  • subjects must have a history of methamphetamine use with recent use confirmed by a positive urine toxicology screen for amphetamines during themonth prior to study entry
  • subjects must meet DSM-IV criteria for amphetamine dependence as assessed by the substance abuse section of the Structured Clinical Interview for DSM-IV (SCID)
  • women of childbearing age must have a negative pregnancy test to enroll in this study, agree to monthly pregnancy testing, and agree to use appropriate forms of birth control for the duration of the study

Exclusion Criteria:

  • current diagnosis of alcohol, opiate, or sedative physical dependence
  • ill health (e.g., major cardiovascular, renal, endocrine, hepatic disorder)
  • history of schizophrenia, or bipolar type I disorder
  • present or recent use of over-the-counter or prescription psychoative drug or drug(s) that would be expected to have major interaction with drug to be tested
  • medical contraindication to receiving study medications (e.g., allergy to modafinil, treatment with cyclosporine, clomipramine, or desipramine)
  • Current suicidality or psychosis
  • liver function tests (i.e., liver enzymes) greater than three times normal levels
  • pregnancy or breastfeeding
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00569374
Carole Hamon, University of Arkansas for Medical Sciences
Protocol / IRB # 79045
University of Arkansas
NIDA Baylor Medications Development Center
Principal Investigator: Dr. Janette McGaugh, MD University of Arkansas
University of Arkansas
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP