Safety and Tolerability of Modafinil for Methamphetmaine Dependence
Information source: University of Arkansas
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Methamphetamine Dependence
Intervention: Modafinil (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: University of Arkansas Official(s) and/or principal investigator(s):
Dr. Janette McGaugh, MD, Principal Investigator, Affiliation: University of Arkansas
Overall contact:
Dr. Janette McGaugh, MD, Phone: 501-686-5803, Email: mcgaughjanetted@uams.edu
Summary
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.
Clinical Details
Official title: Safety and Tolerability of Modafinil for Methamphetamine Dependence
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Safety and tolerability of modafinil in methamphetamine-dependent persons
Secondary outcome: Treatment retention and illicit drug use
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Dr. Janette McGaugh, MD, Phone: 501-686-5803, Email: mcgaughjanetted@uams.edu
University of Arkansas for Medical Sciences, Little Rock, Arkansas 72205, United States; Recruiting
Additional Information
Starting date: September 2007
Last updated: June 2, 2008
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