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Enhancing the Effects of Adolescent Alcohol Treatment With Atomoxetine

Primary Purpose

Alcohol Use Disorder

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Atomoxetine
Placebo
Sponsored by
Brown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder

Eligibility Criteria

14 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Brown University Center for Alcohol and Addiction Studies

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Atomoxetine

Placebo

Arm Description

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

Identical matching placebo capsules

Outcomes

Primary Outcome Measures

Completion rates
Percentage of youth who complete the active medication phase will determine feasibility.
Acceptability of the study medication
Study withdrawal and the Client Satisfaction Questionnaire (CSQ-8), which ranges in scores from 8-32 (higher scores indicates higher satisfaction), will determine acceptability.

Secondary Outcome Measures

Alcohol Craving
The primary measure of alcohol craving will be the following single-item: How strong is your craving to drink alcohol? Scores range from 0 (None) to 20 (Extremely Strong).

Full Information

First Posted
August 28, 2020
Last Updated
March 21, 2023
Sponsor
Brown University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT04565288
Brief Title
Enhancing the Effects of Adolescent Alcohol Treatment With Atomoxetine
Official Title
Enhancing the Effects of Adolescent Alcohol Treatment With Atomoxetine
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 6, 2021 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Brown University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Atomoxetine
Arm Type
Experimental
Arm Description
Atomoxetine (40 mg/day for 3 days then 80 mg/day thereafter) during a 6-week medication trial
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Identical matching placebo capsules
Intervention Type
Drug
Intervention Name(s)
Atomoxetine
Other Intervention Name(s)
Strattera
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
Matching placebo (sugar pill)
Primary Outcome Measure Information:
Title
Completion rates
Description
Percentage of youth who complete the active medication phase will determine feasibility.
Time Frame
6-week active treatment phase
Title
Acceptability of the study medication
Description
Study withdrawal and the Client Satisfaction Questionnaire (CSQ-8), which ranges in scores from 8-32 (higher scores indicates higher satisfaction), will determine acceptability.
Time Frame
6-week active treatment phase
Secondary Outcome Measure Information:
Title
Alcohol Craving
Description
The primary measure of alcohol craving will be the following single-item: How strong is your craving to drink alcohol? Scores range from 0 (None) to 20 (Extremely Strong).
Time Frame
6-week active treatment phase

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Miranda, PhD
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brown University Center for Alcohol and Addiction Studies
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be uploaded into the appropriate NIH repository as required.
IPD Sharing Time Frame
Within 12-months of publication
IPD Sharing Access Criteria
Any investigator who requests access in writing will be provided with the requested information.

Learn more about this trial

Enhancing the Effects of Adolescent Alcohol Treatment With Atomoxetine

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