Enhancing the Effects of Adolescent Alcohol Treatment With Atomoxetine
Status:
Recruiting
Trial end date:
2023-05-01
Target enrollment:
Participant gender:
Summary
The primary objectives of this study are twofold. The first primary objective is to evaluate
the feasibility, acceptability, and tolerability of atomoxetine (40 mg/day for 3 days then 80
mg/day thereafter) as compared to placebo for 6 weeks plus a psychosocial platform comprised
of motivational enhancement therapy and cognitive behavioral therapy (MET-CBT) among
adolescents (ages 14 to 19 years) with alcohol use disorder as confirmed by the Diagnostic
and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5™). The second primary
objective is to leverage a human laboratory paradigm and ecological momentary assessment
(EMA) methods to evaluate the effects of atomoxetine on intermediate phenotypes associated
with alcohol use and outcomes in clinical trials.
Phase:
Phase 2
Details
Lead Sponsor:
Brown University
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)