NCT04565288

Enhancing the Effects of Adolescent Alcohol Treatment With Atomoxetine

Completed Phase 2 Results posted Last updated 9 May 2025

What this trial tests

Phase 2 trial testing Atomoxetine in Alcohol Use Disorder in 42 participants. Completed in 16 May 2023.

Timeline

6 May 2021

Primary endpoint
16 May 2023

16 May 2023

Quick facts

Lead sponsor	Brown University
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	42
Start date	6 May 2021
Primary completion	16 May 2023
Estimated completion	16 May 2023
Sites	1 location across United States

Drugs / interventions tested

• Atomoxetine (ATOMOXETINE) — full drug profile →
• Placebo

Conditions studied

• Alcohol Use Disorder — all drugs for Alcohol Use Disorder →

Sponsor

Brown University

Who can join

Adults 14 to 20, any sex, with Alcohol Use Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Completion Rates Primary · 6-week active treatment phase

Number and percentage of youth who complete the active medication phase will determine feasibility.

Group	Value	95% CI
Atomoxetine	17
Placebo	18

Number of Participants Who Rate Their Treatment Experience in the "Satisfactory" or "Highly Satisfactory" Range on the CSQ-8 Primary · 6-week active treatment phase

The Client Satisfaction Questionnaire (CSQ-8), which ranges in scores from 8 to 32 (higher scores indicate higher satisfaction), will determine acceptability. Treatment satisfaction will be considered acceptable if the number and percentage of subjects who rate their treatment experience in the "satisfactory" or "highly satisfactory" range on the CSQ-8 is ≥ 80%.

Group	Value	95% CI
Atomoxetine	21
Placebo	19

Alcohol Craving Secondary · Alcohol craving was assessed during a laboratory alcohol-cue exposure paradigm, at week 5. Participants rated their alcohol craving immediately following exposure to alcohol and water cues. The outcomes measure is craving after alcohol cue exposure.

The primary measure of alcohol craving is the number and percentage of participants who report any level of alcohol craving during a laboratory alcohol-cue exposure paradigm using the following single item: How strong is your craving to drink alcohol? Scores range from 0 (None) to 20 (Extremely Strong). Individuals who endorse any level of alcohol craving (e.g., \> 1) are considered to experience craving. Individuals who do not report any alcohol craving (e.g., 0) will be regarded as non-craving.

Group	Value	95% CI
Atomoxetine	5
Placebo	16

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected during the 6-week treatment period.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Atomoxetine

Serious: 0/21 (0%)

Deaths: 0/21

Placebo

Serious: 0/21 (0%)

Deaths: 0/21

Other adverse events (18 terms — click to expand)

Reaction	System	Atomoxetine	Placebo
Nausea	Gastrointestinal disorders	—	—
Hypertension	Cardiac disorders	—	—
Headache	General disorders	—	—
Flu-like symptoms	General disorders	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—
Insomnia	General disorders	—	—
Sore throat	General disorders	—	—
Nasal congestion	General disorders	—	—
Drowsiness	General disorders	—	—
Anxiety	Psychiatric disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Weight gain	Metabolism and nutrition disorders	—	—
Decreased appetite	Gastrointestinal disorders	—	—
Fever	General disorders	—	—
Stomach pain	Gastrointestinal disorders	—	—
Tingling	General disorders	—	—
Heart racing	Cardiac disorders	—	—
Increased appetite	Metabolism and nutrition disorders	—	—

Data from ClinicalTrials.gov NCT04565288 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.