A Dose Ranging Study of Modafinil for Methamphetamine Dependence
Status:
Unknown status
Trial end date:
2011-06-01
Target enrollment:
Participant gender:
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 randomized dose ranging
clinical trial of modafinil to establish its safety and efficacy as a pharmacotherapy for
methamphetamine dependence.
Phase:
Phase 2
Details
Lead Sponsor:
California Pacific Medical Center Research Institute