A Pilot Trial of Modafinil for Treatment of Methamphetamine Dependence
Information source: California Pacific Medical Center Research Institute
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Methamphetamine Addiction
Intervention: modafinil (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: California Pacific Medical Center Research Institute Official(s) and/or principal investigator(s):
Gantt Galloway, Pharm D., Principal Investigator, Affiliation: California Pacific Medical Center
Overall contact:
Gantt Galloway, Pharm D., Phone: (415)641-3383, Email: gantt@cpmcri.org
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 such as the
amphetamines, methylphenidate, and pemoline. 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 co-administered with intravenous
methamphetamine. We will conduct a pilot, open-label clinical trial of modafinil to establish
its safety and efficacy as a pharmacotherapy for methamphetamine dependence.
Specific Aims:
1. Determine the safety of modafinil in the treatment of methamphetamine dependence.
2. Determine the efficacy of modafinil in the treatment of methamphetamine dependence.
3. Assess the effect of modafinil on cognitive function in methamphetamine users.
4. Assess the effect of modafinil on methamphetamine withdrawal symptoms.
5. Compare the validity of a cellular telephone-based reporting system for assessing
medication regimen adherence to conventional electronic medication monitoring.
Hypotheses:
1. Modafinil will be as safe and well tolerated as placebo in a comparison group from
another study.
2. Subjects given modafinil will use less methamphetamine than subjects given placebo.
3. Subjects given modafinil with demonstrate improvements in cognitive function when
compared to subjects given placebo.
4. Subjects given modafinil will have reduced withdrawal symptoms when compared to subjects
given placebo.
5. Adherence will be recorded more accurately by cellular telephone than by conventional
electronic medication monitoring.
Clinical Details
Official title: A Pilot Trial of Modafinil for Treatment of Methamphetamine Dependence
Study design: Treatment, Open Label, Crossover Assignment
Primary outcome: MA (-) urine samples
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Age between 18 and 50 years
- Patient is agreeable to conditions of study and signs consent form
- Fluency in English
Contact site for additional information.
Locations and Contacts
Gantt Galloway, Pharm D., Phone: (415)641-3383, Email: gantt@cpmcri.org
CPMC - St. Luke's Hospital ~ 7th Floor/ Addiction Pharmacology Research Lab, San Francisco, California 94110, United States; Recruiting
Galloway, Phone: 415-641-3370
Additional Information
Starting date: January 2008
Ending date: January 2009
Last updated: March 7, 2008
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