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Propranolol for Alcohol Use Disorders

Phase 2
Recruiting
Led By Sherry McKee, PhD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 21-65
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 120 minutes
Awards & highlights

Study Summary

This trial is testing whether propranolol can help people with alcohol use disorders by reducing alcohol consumption.

Who is the study for?
This trial is for adults aged 21-65 who have been diagnosed with alcohol use disorders in the last 6 months, can read and write English, and are willing to take oral medication regularly. It's not suitable for those at risk of severe alcohol withdrawal, with serious health issues, pregnant or nursing women not using effective birth control, or individuals with recent mental illness.Check my eligibility
What is being tested?
The study tests if Propranolol (a beta blocker) at a dose of 160mg/day can reduce stress-induced alcohol consumption compared to a placebo. Participants will undergo two lab sessions after a two-week period of taking the drug to see how it affects their drinking behavior under induced stress versus a relaxed state.See study design
What are the potential side effects?
While specific side effects aren't listed here, common ones associated with Propranolol include dizziness, tiredness, and upset stomach. Since it's being used in people with alcohol use disorders, participants should be monitored closely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 21 and 65 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~120 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 120 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Alcohol consumption

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: PropranololExperimental Treatment1 Intervention
Propranolol extended release (160mg/day). Administered orally once daily at 10:00PM. Titration schedule Days 1-3 60mg, Days 4-7 80mg, Days 8-11 120mg, and Days 12-14 160mg until steady state.
Group II: PlaceboPlacebo Group1 Intervention
Administered orally once daily at 10:00PM
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Propranolol
2010
Completed Phase 4
~1290

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,852 Previous Clinical Trials
2,738,421 Total Patients Enrolled
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
801 Previous Clinical Trials
1,365,265 Total Patients Enrolled
Sherry McKee, PhDPrincipal Investigator - Professor
Yale University
5 Previous Clinical Trials
416 Total Patients Enrolled

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT03588754 — Phase 2
Alcohol Consumption Research Study Groups: Propranolol, Placebo
Alcohol Consumption Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT03588754 — Phase 2
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT03588754 — Phase 2

Frequently Asked Questions

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

Who is eligible to partake in this research endeavor?

"This trial is seeking 20 adults of legal drinking age (21 - 65) who are currently consuming alcohol. Specifically, applicants should satisfy the following criteria: Age 21-65."

Answered by AI

Is Propranolol known to be hazardous for those using it?

"Clinical evidence supports propranolol's safety, so it was ranked a 2 on our team's scale. As this is Phase 2 trial, we have yet to see data confirming its efficacy."

Answered by AI

In what scenarios is Propranolol most frequently recommended?

"Propranolol can be used to manage the risks of cardiovascular mortality, angina pectoris, and myocardial infarction."

Answered by AI

Are individuals aged 35 and above eligible to join this research endeavor?

"This clinical trial has imposed age restrictions, with the minimum being 21 and the maximum 65."

Answered by AI

To what extent is enrollment in this medical study being restricted?

"Affirmative. According to the information hosted on clinicaltrials.gov, this medical study is actively seeking participants and was first announced on September 15th 2018 with an update posted January 31st 2022. This trial requires 20 enrollees at 1 site."

Answered by AI

Are any new participants being admitted to this research endeavor?

"Affirmative. Records on clinicaltrials.gov show that this research is currently recruiting subjects, with the original posting date being September 15th 2018 and most recent update occurring on January 31st 2022. In total, 20 individuals are needed from one medical centre."

Answered by AI
~3 spots leftby Feb 2025