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

NCT03588754 | Active Not Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: 2000022090R01AA0222851U54AA027989-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Drinking

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Propranolol

EXPERIMENTAL

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.

Drug: Propranolol

Placebo

PLACEBO COMPARATOR

Administered orally once daily at 10:00PM

Drug: Placebo

Interventions

Propranolol DRUG

Propranolol Extended Release (160mg/day).

Propranolol

Placebo DRUG

Placebo pill administered orally.

Placebo

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 21-65
• Able to read and write English
• Meets Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for current (past 6 months) alcohol use disorders
• Able to take oral medications and willing to adhere to medication regimen

You may not qualify if:

• Participants with any significant current medical conditions.
• 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)
• Suicidal, homicidal or evidence of current (past 6-month) mental illness.
• Subjects likely to exhibit clinically significant alcohol withdrawal during the study.

Sponsors & Collaborators

• Yale University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Yale University School of Medicine

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Alcohol Drinking

Interventions

Propranolol

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Sherry McKee, PhD

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2018
• First Posted: July 17, 2018
• Study Start: September 15, 2018
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)