Enhancing the Effects of Adolescent Alcohol Treatment With Atomoxetine

NCT ID: NCT04565288

Last Updated: 2025-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-06
• Study Completion Date: 2023-05-16

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.

Detailed Description

This proof-of-concept study is a double-blind, randomized, placebo-controlled, parallel-group, single-site study designed to assess the feasibility, acceptability, and tolerability of atomoxetine for alcohol use disorder among adolescents ages 14 to 19 years. In addition, this project will test the effects of atomoxetine, as compared with placebo, on responses to in vivo alcohol cue exposure in the human laboratory setting. After obtaining consent/parent permission/assent, youth and, if younger than 18 years, their parent will complete a medical history interview to screen for eligibility. Youth will also be screened for eligibility. If eligible for the study, participants will be randomized in an approximate 1:1 ratio (targeting 21 participants per group - 42 participants total) to either atomoxetine or placebo for 6 weeks. Atomoxetine will be dosed at 40 mg/day for three days then increased to the maintenance dose of 80 mg (active) taken orally once daily (QD) for an additional 5.5 weeks. Participants randomized to the placebo condition will be given an equal number of visually matched capsules.

Participants will be seen in the clinic at the in-person screening appointment, the randomization/baseline session, and at 8 other times during the study. Three follow-up telephone interviews will occur at 2 weeks and three and six months after the last in-clinic visit. At the randomization/baseline visit and after 4 weeks of investigational product administration (i.e., Study Week 7), participants will undergo a human laboratory paradigm (i.e., alcohol cue reactivity assessment). In addition, participants will complete EMA on a smartphone throughout the day in their daily lives.

Conditions

Alcohol Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Atomoxetine

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

Group Type: EXPERIMENTAL

Atomoxetine

Intervention Type: 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).

Placebo

Identical matching placebo capsules

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo (sugar pill)

Interventions

Atomoxetine

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).

Intervention Type: DRUG

Placebo

Matching placebo (sugar pill)

Intervention Type: DRUG

Other Intervention Names

Strattera

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• Current (past year) suicidality risk
• Known sensitivity to atomoxetine
• Be anyone who in the opinion of the investigator could not be safely withdrawn from alcohol without medical detoxification
• Serious or unstable medical illness or any potentially life-threatening or progressive medical condition other than addiction that may compromise subject safety or study conduct
• Abnormal calculated creatinine clearance defined as < 80 mL/min
• Evidence of cirrhosis of the liver (albumin < 3.2 g/dL, or ascites by physical exam)

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

Brown University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Miranda, PhD

Role: PRINCIPAL_INVESTIGATOR

Brown University

Locations

Brown University Center for Alcohol and Addiction Studies

Providence, Rhode Island, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

K24AA026326

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1805002051

Identifier Type: -

Identifier Source: org_study_id