Amphetamine Dependence, Substance Dependence
Conditions
Keywords
methamphetamine addiction, meth dependence
Brief 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.
Interventions
DRUGmodafinil
Modafinil, 100mg, 400mg, or 600 mg tablets QD for 4 weeks.
Sponsors
California Pacific Medical Center Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 18 and 50 years 2. Patient is agreeable to conditions of study and signs consent form
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Methamphetamine-negative urine samples will be analyzed using a generalized estimating equation model | end of study |
Countries
United States
Outcome results
None listed