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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

Must not have

Women who are pregnant or nursing, or fail to use specified methods of birth control

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 120 minutes

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.

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.

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

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I am between 21 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant, nursing, and I use approved birth control methods.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 120 minutes

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

0 / 2Eligibility criteria met