drugset / Trial / NCT04565288

Enhancing the Effects of Adolescent Alcohol Treatment With Atomoxetine

NCT04565288

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2021-05-06
Primary completion
2023-05-16
Completion
2023-05-16

Drugs

EvaluationDrugModalityDoseRoute
Subject Atomoxetine Other / unclassified 80 mg Oral

Indications