A Dose Ranging Study of Modafinil for 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: Substance Dependence; Amphetamine Dependence
Intervention: modafinil (Drug)
Phase: Phase 2
Status: Not yet recruiting
Sponsored by: California Pacific Medical Center Research Institute Official(s) and/or principal investigator(s):
Gantt Galloway, PharmD, Principal Investigator, Affiliation: California Pacific Medical Center
Overall contact:
Kathleen Garrison, Phone: 415-641-3370, Email: garrisk@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. 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
coadministered with intravenous methamphetamine. We will conduct a placebo-controlled,
randomized dose ranging clinical trial of modafinil to establish its safety and efficacy as a
pharmacotherapy for methamphetamine dependence.
Clinical Details
Official title: A Dose Ranging Study of Modafinil for Methamphetamine Dependence
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Methamphetamine-negative urine samples will be analyzed using a generalized estimating equation model
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Age between 18 and 50 years
2. Patient is agreeable to conditions of study and signs consent form
Locations and Contacts
Kathleen Garrison, Phone: 415-641-3370, Email: garrisk@cpmcri.org
CPMC, San Francisco, California 94110, United States
Additional Information
Starting date: June 2008
Last updated: February 27, 2008
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