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NCT04565288 · ClinicalTrials.gov registry record · Phase 2
Enhancing the Effects of Adolescent Alcohol Treatment With Atomoxetine
A Phase 2 study, sponsored by Brown University.
- Completed
- Registry status
- Phase 2
- Development phase
- 42
- Enrollment target
NCT04565288 is a Phase 2 study that has completed, run by Brown University. The registered enrollment target is 42 participants.
The verdict
NCT04565288, a Phase 2 study, has completed, sponsored by Brown University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 42 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- DRUG Atomoxetine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2021-05-06 |
| Est. Completion | 2023-05-16 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04565288
The ClinicalTrials.gov registry entry for NCT04565288 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Brown University, which has 231 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04565288 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04565288 about?
NCT04565288 is a clinical study titled "Enhancing the Effects of Adolescent Alcohol Treatment With Atomoxetine". 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 enha...
What is the current status of trial NCT04565288?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 2021-05-06. Estimated completion is 2023-05-16.
What interventions are being tested in trial NCT04565288?
The interventions under investigation include: Placebo (DRUG), Atomoxetine (DRUG).
Who is sponsoring clinical trial NCT04565288?
This trial is sponsored by Brown University, which has 231 total clinical trials registered on ClinicalTrials.gov.
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