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Norepinephrine Reuptake Inhibitor

Atomoxetine for Alcoholism

Phase 2
Waitlist Available
Led By Robert Miranda, PhD
Research Sponsored by Brown University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-week active treatment phase
Awards & highlights

Study Summary

This trial is testing whether a drug called atomoxetine, plus therapy, can help reduce alcohol use in teens with an alcohol use disorder. The trial will also use a human laboratory paradigm and ecological momentary assessment (EMA) methods to study how atomoxetine affects intermediate phenotypes associated with alcohol use and outcomes in clinical trials.

Eligible Conditions
  • Alcoholism

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-week active treatment phase
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-week active treatment phase for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acceptability of the study medication
Completion rates
Secondary outcome measures
Alcohol Craving

Side effects data

From 2011 Phase 4 trial • 232 Patients • NCT00183391
6%
Appetite Loss
6%
Irritability
6%
Aggression
5%
Insomnia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Block 1 ATX
Block 1 MPH
Block 2 ATX
Block 2 MPH

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: AtomoxetineExperimental Treatment1 Intervention
Atomoxetine (40 mg/day for 3 days then 80 mg/day thereafter) during a 6-week medication trial
Group II: PlaceboPlacebo Group1 Intervention
Identical matching placebo capsules
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atomoxetine
2010
Completed Phase 4
~431790

Find a Location

Who is running the clinical trial?

Brown UniversityLead Sponsor
456 Previous Clinical Trials
563,039 Total Patients Enrolled
29 Trials studying Alcoholism
5,473 Patients Enrolled for Alcoholism
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
800 Previous Clinical Trials
1,362,969 Total Patients Enrolled
423 Trials studying Alcoholism
985,666 Patients Enrolled for Alcoholism
Robert Miranda, PhDPrincipal InvestigatorBrown University
2 Previous Clinical Trials
100 Total Patients Enrolled
2 Trials studying Alcoholism
100 Patients Enrolled for Alcoholism

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment process still open for this trial?

"Affirmative. Clinicaltrials.gov displays that this medical experiment, which was first posted on May 6th 2021, is actively recruiting participants. Approximately 42 people need to be enrolled from 1 clinical site."

Answered by AI

To what extent is participation in this trial restricted?

"Affirmative, the information on clinicaltrials.gov implies that this medical trial is presently seeking volunteers. This study was originally made available to public view on May 6th 2021 and its details were most recently revised on May 5th 2022. 42 participants are being sought from 1 location in total."

Answered by AI

Does the US Federal Drug Administration endorse Atomoxetine?

"Atomoxetine received a mark of 2 on the safety scale because it is in Phase 2, signifying that there are some studies showing its safety but none demonstrating efficacy."

Answered by AI

Are there any other research endeavors concerning Atomoxetine?

"Currently, 12 studies are being conducted on Atomoxetine with two of those trials in the Phase 3 stage. In terms of location availability, 86 sites have active clinical trials while the bulk can be found in Almere and California."

Answered by AI

Does my profile meet the criteria for participating in this research?

"This trial seeks 42 individuals aged between 14 and 20 who have an AUD diagnosis as defined in the DSM-5. Participants must be willing to adhere to a medication regimen, understand the consent form, provide contact information for someone close (if under 18), complete all assessment requirements, and demonstrate they will finish the study protocol. Furthermore, subjects should self-report consuming alcohol at least 2 days/week during their past 28 day period and are able to take oral medications while being fluent in English."

Answered by AI

Is the eligibility criterion for this study limited to those under 45 years of age?

"According to the admission criteria, eligible patients must be between 14 and 20 years of age."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Enhancing the Effects of Adolescent Alcohol Treatment With Atomoxetine
2021. "Enhancing the Effects of Adolescent Alcohol Treatment With Atomoxetine". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04565288.
~11 spots leftby Apr 2025
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