Alcohol Use DisorderPhase 2NCT04565288
Enhancing the Effects of Adolescent Alcohol Treatment With Atomoxetine
A Phase 2 study testing Atomoxetine in people with Alcohol Use Disorder, run by Brown University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 20 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Atomoxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2021to 16 May 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Brown University Center for Alcohol and Addiction Studies
Providence, Rhode Island, 02903
About this study
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.
Read the 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
- Being tested
- Atomoxetine, Placebo
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtomoxetineDrug
Also called Strattera
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).
PlaceboDrug
Matching placebo (sugar pill)
| Study group | Role | What they receive |
|---|---|---|
| Atomoxetine | Experimental | Atomoxetine (40 mg/day for 3 days then 80 mg/day thereafter) during a 6-week medication trial Receives: Drug: Atomoxetine |
| Placebo | Placebo comparator | Identical matching placebo capsules Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion Rates
Number and percentage of youth who complete the active medication phase will determine feasibility.
Measured: 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%.
Measured: 6-week active treatment phase
Secondary outcomes (1)
Alcohol Craving
The primary measure of alcohol craving is the number and percentage of participants who report any level of alcohol craving during a laboratory alcohol-cue exposure paradigm using the following single item: How strong is your craving to drink alcohol? Scores range from 0 (None) to 20 (Extremely Strong). Individuals who endorse any level of alcohol craving (e.g., > 1) are considered to experience craving. Individuals who do not report any alcohol craving (e.g., 0) will be regarded as non-craving.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start6 May 2021
- Primary completion16 May 2023
- Study completion16 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Robert Miranda, PhD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04565288
- Sponsor's protocol ID
- 1805002051
- Other IDs
- K24AA026326
- Status last verified
- Apr 2025
- First submitted
- 28 Aug 2020
- Last updated
- 9 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be uploaded into the appropriate NIH repository as required.
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing the Effects of Adolescent Alcohol Treatment With Atomoxetine
- ClinicalTrials.gov ID
- NCT04565288
- Acronym / sponsor ID
- 1805002051
- Conditions
- Alcohol Use Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 6 May 2021 (actual)
- Primary completion
- 16 May 2023 (actual)
- Study completion
- 16 May 2023 (actual)
- First posted
- 25 Sep 2020 (actual)
- Results
- Posted 9 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atomoxetine | Experimental | Drug: AtomoxetineAtomoxetine (40 mg/day for 3 days then 80 mg/day thereafter) during a 6-week medication trial |
| Placebo | Placebo comparator | Drug: PlaceboIdentical matching placebo capsules |
Who may qualify
- Ages
- 14 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtomoxetineAlso: StratteraParticipants 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). | Drug | Atomoxetine |
| PlaceboMatching placebo (sugar pill) | Drug | Placebo |
Primary outcome
Completion Rates
Time frame: 6-week active treatment phase
Number and percentage of youth who complete the active medication phase will determine feasibility.
Number of Participants Who Rate Their Treatment Experience in the "Satisfactory" or "Highly Satisfactory" Range on the CSQ-8
Time frame: 6-week active treatment phase
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%.
1 secondary outcome
Alcohol Craving
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Data will be uploaded into the appropriate NIH repository as required.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Miranda, PhD principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atomoxetine in people with Alcohol Use Disorder, run by Brown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion Rates (time frame: 6-week active treatment phase). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.