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

Sponsor
Yale University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03588754
Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)
20
Enrollment
1
Location
2
Arms
89.5
Anticipated Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Does Propranolol, a Beta Blocker, Attenuate Stress-Induced Drinking?
Actual Study Start Date :
Sep 15, 2018
Anticipated Primary Completion Date :
Feb 28, 2025
Anticipated Study Completion Date :
Feb 28, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Drug: Propranolol
Propranolol Extended Release (160mg/day).
Placebo Comparator: Placebo

Administered orally once daily at 10:00PM

Drug: Placebo
Placebo pill administered orally.

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Yale University School of Medicine New Haven Connecticut United States 06519

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Sherry McKee, PhD, Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sherry McKee, Professor, Yale University
ClinicalTrials.gov Identifier:
NCT03588754
Other Study ID Numbers:
  • 2000022090
  • R01AA022285
  • U54AA027989
First Posted:
Jul 17, 2018
Last Update Posted:
Feb 2, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Alcohol Drinking
Propranolol

Study Results

No Results Posted as of Feb 2, 2022