Enhancing the Effects of Adolescent Alcohol Treatment With Atomoxetine

NCT04565288 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 1805002051K24AA026326
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alcohol Use Disorder

Outcome Measures

Primary Outcomes (2)

• Completion Rates

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

  6-week active treatment phase

• Number of Participants Who Rate Their Treatment Experience in the "Satisfactory" or "Highly Satisfactory" Range on the CSQ-8

  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%.

  6-week active treatment phase

Secondary Outcomes (1)

• Alcohol Craving

  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.

Study Arms (2)

Atomoxetine

EXPERIMENTAL

Atomoxetine (40 mg/day for 3 days then 80 mg/day thereafter) during a 6-week medication trial

Drug: Atomoxetine

Placebo

PLACEBO COMPARATOR

Identical matching placebo capsules

Drug: Placebo

Interventions

Atomoxetine DRUG

Participants randomized to receive the study medication, atomoxetine (brand name: Straterra) for 6-weeks (40 mg/day for 3 days then 80 mg/day thereafter). A comparator group will receive placebo (sugar pills).

Also known as: Strattera

Atomoxetine

Placebo DRUG

Matching placebo (sugar pill)

Placebo

Eligibility Criteria

• Age: 14 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Ages 14 to 20 years, inclusive
• Self-reports consuming alcohol ≥ 2 days/week on average in the past 28 days
• Meets the DSM-5 criteria for alcohol use disorder (AUD)
• Interested in reducing alcohol use
• Be able to verbalize an understanding of the consent/assent form, able to provide written informed consent/assent, verbalize willingness to complete study procedures, able to understand written and oral instructions in English, and able to complete the questionnaires required by the protocol.
• If younger than 18 years, parent permissions is required.
• Be able to take oral medication and be willing to adhere to the medication regimen
• Complete all assessments required at screening and baseline
• Provide contact information of someone, such as a parent or other family member, who may be able to contact the subject in case of a missed clinic appointment or follow-up assessment.
• Be someone who in the opinion of the investigator would be expected to complete the study protocol
• Agree to the schedule of visits, verbally acknowledge that s/he will be able to attend each scheduled visit, participate in phone visits and that s/he does not have any already scheduled events or a job that may substantially interfere with study participation.
• Not anticipate any significant problems with transportation arrangements or available time to travel to the study site over the next 2 months.
• Agree (if the subject is female and of child bearing potential) to use birth control

You may not qualify if:

• Currently receiving treatment for AUD
• Significant alcohol withdrawal symptoms
• Coexisting moderate to severe substance use disorder other than cannabis and nicotine
• Urine toxicology screen positive drugs of abuse except for cannabis
• Treated with pharmacotherapy for AUD or a carbonic anhydrase inhibitor in past 30 days
• Compelled to alcohol treatment by the juvenile justice system or has probation or parole requirements that might interfere with study participation
• History of liver disease or have clinically significant abnormal laboratory values
• History of renal impairment or renal stones, narrow angle glaucoma or pheochromocytoma, heart problems or defects, abnormal blood pressure, progressive neurodegenerative disorder, or clinically significant neurological disorders
• Clinically significant physical abnormalities per physical exam, hematological assessment, bilirubin concentration, or urinalysis
• Pregnancy, nursing, or refusal to use reliable birth control, if female
• Psychotropic medication use in the past 30 days
• Current or lifetime diagnosis of psychotic disorders
• Current bipolar disorder
• Current major depressive episode
• Ever attempted suicide

Sponsors & Collaborators

• Brown University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Brown University Center for Alcohol and Addiction Studies

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Atomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Limitations and Caveats

The purpose of this preliminary pilot trial was to establish the feasibility and acceptability of atomoxetine for treating alcohol use disorder among adolescents. The findings do not address whether this medication is efficacious for this purpose.

Results Point of Contact

• Title: Dr. Robert Miranda Jr.
• Organization: Brown University

Robert_Miranda_Jr@brown.edu

401-863-6658

Study Officials

• Robert Miranda, PhD

  Brown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2020
• First Posted: September 25, 2020
• Study Start: May 6, 2021
• Primary Completion: May 16, 2023
• Study Completion: May 16, 2023
• Last Updated: May 9, 2025
• Results First Posted: May 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF, ANALYTIC CODE
• Time Frame: Within 12-months of publication
• Access Criteria: Any investigator who requests access in writing will be provided with the requested information.

Locations

US (1)