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

Phase 2

Active, not recruiting

• Conditions: Alcohol Drinking
• Interventions: Drug: Propranolol; Drug: Placebo

• Registration Number: NCT03588754
• Lead Sponsor: Yale University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-03
• Study First Submitted QC: 2018-07-13
• Study First Posted: 2018-07-17
• Study Start: 2018-09-15
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-28
• Last Update Posted: 2025-03-03
• Primary Completion: 2026-02-28
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propranolol	Propranolol	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.
Placebo	Placebo	Administered orally once daily at 10:00PM

Primary Outcome Measures

Name	Time	Method
Alcohol consumption	120 minutes	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.

Trial Locations

Locations (1)

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States