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Phase 2 Completed N=42 Randomized Quadruple-blind Treatment

Enhancing the Effects of Adolescent Alcohol Treatment With Atomoxetine

Source: ClinicalTrials.gov NCT04565288 ↗
Enrolled (actual)
42
Serious AEs
0.0%
Results posted
May 2025
Primary outcomePrimary: Completion Rates — 17; 18 Participants

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Completion Rates
17; 18
PRIMARY
Number of Participants Who Rate Their Treatment Experience in the "Satisfactory" or "Highly Satisfactory" Range on the CSQ-8
21; 19
SECONDARY
Alcohol Craving
5; 16

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)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04565288). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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