Enhancing the Effects of Adolescent Alcohol Treatment With Atomoxetine

• Status: Recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brown University
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Treatments: Atomoxetine Hydrochloride

Criteria

Inclusion Criteria:

• Ages 14 to 19 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)