Does Propranolol, a Beta Blocker, Attenuate Stress-Induced Drinking?

Alcohol Drinking Clinical Trial

Official title:

Does Propranolol, a Beta Blocker, Attenuate Stress-Induced Drinking?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03588754
• Other study ID #: 2000022090
• Secondary ID: R01AA022285U54AA
• Status: Recruiting
• Phase: Phase 2
• Start date: September 15, 2018
• Est. completion date: February 28, 2025

Study information

• Verified date: March 2024
• Source: Yale University
• Contact: Sabrina Coppola
• Phone: 203-737-2827
• Email: sabrina.coppola[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

For this protocol, the investigators plan to conduct a pilot study evaluating the effect of propranolol on alcohol consumption. Using a parallel design, the investigators plan to randomize 20 non-treatment seeking adults with alcohol use disorders (DSM-5) to propranolol extended release (160mg/day or placebo; n=10 per cell) to evaluate whether propranolol reduces alcohol self-administered in the laboratory. Importantly, the investigators will evaluate whether propranolol counteracts stress-induced effects on alcohol self-administration. Following titration to steady state medication levels over a 2-week period, each subject will complete two laboratory sessions consisting of a well validated method for inducing stress or neutral/relaxing state (order counterbalanced), followed by a 2-hour alcohol self-administration paradigm known to be sensitive to medication effects.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: February 28, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Age 21-65

2. Able to read and write English

3. Meets Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for current (past 6 months) alcohol use disorders

4. Able to take oral medications and willing to adhere to medication regimen

Exclusion Criteria:

1. Participants with any significant current medical conditions.

2. Women who are pregnant or nursing, or fail to use one of the following methods of birth control unless she or partner is surgically sterile or she is postmenopausal (hormone contraceptives [oral, implant, injection, patch, or ring], contraceptive sponge, double barrier [diaphragm or condom plus spermicide], or IUD)

3. Suicidal, homicidal or evidence of current (past 6-month) mental illness.

4. Specific exclusions for administration of propranolol not already specified.

5. Subjects likely to exhibit clinically significant alcohol withdrawal during the study.

Related Conditions & MeSH terms

• Alcohol Drinking

Intervention

Drug:
• Propranolol
Propranolol Extended Release (160mg/day).
• Placebo
Placebo pill administered orally.

Locations

Country	Name	City	State
United States	Yale University School of Medicine	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alcohol consumption	Mean mls of alcohol consumed (maximum of 120 mg/dL) for propranolol and placebo groups during 120 minute alcohol self administration sessions taking place as close to Day 15 and Day 19 as possible of medication dosing.	120 minutes