Status:
TERMINATED
Modafinil for Methamphetamine Dependence
Lead Sponsor:
University of Arkansas
Conditions:
Methamphetamine Dependence
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Fifty methamphetamine dependent treatment-seeking volunteers will be enrolled in this 10 week, double bind, placebo controlled, randomized clinical trial to receive either modafinil or placebo. Eligib...
Eligibility Criteria
Inclusion
- 18-65 years old. For the neurophysiological measures portion of the study subjects will be included if they are between the ages of 20-65 because the P50 potential is not fully developed in children and adolescents (Rasco 2000).
- 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 the month 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
- 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 psychoactive 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00859573
Start Date
April 1 2009
End Date
January 1 2010
Last Update
November 21 2017
Active Locations (1)
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1
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205