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

Primary Purpose

Alcohol Drinking

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Propranolol

Placebo

Sponsored by

Yale University

About this trial

This is an interventional treatment trial for Alcohol Drinking

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.
Specific exclusions for administration of propranolol not already specified.
Subjects likely to exhibit clinically significant alcohol withdrawal during the study.

Sites / Locations

Yale University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Propranolol

Placebo

Arm Description

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.

Administered orally once daily at 10:00PM

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

First Posted

July 3, 2018

Last Updated

October 12, 2023

Sponsor

Yale University

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

1. Study Identification

Unique Protocol Identification Number

NCT03588754

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 15, 2018 (Actual)

Primary Completion Date

February 28, 2025 (Anticipated)

Study Completion Date

February 28, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Yale University

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

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

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alcohol Drinking

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Propranolol

Arm Type

Experimental

Arm Description

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.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Administered orally once daily at 10:00PM

Intervention Type

Drug

Intervention Name(s)

Propranolol

Intervention Description

Propranolol Extended Release (160mg/day).

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo pill administered orally.

Primary Outcome Measure Information:

Title

Alcohol consumption

Description

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.

Time Frame

120 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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. Specific exclusions for administration of propranolol not already specified. Subjects likely to exhibit clinically significant alcohol withdrawal during the study.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sabrina Coppola

Phone

203-737-2827

Email

sabrina.coppola@yale.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Paula Cunningham

Phone

203-785-3547

Email

paula.cunningham@yale.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sherry McKee, PhD

Organizational Affiliation

Professor

Official's Role

Principal Investigator

Facility Information:

Facility Name

Yale University School of Medicine

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06519

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sabrina Coppola

Phone

203-737-2827

Email

sabrina.coppola@yale.edu

First Name & Middle Initial & Last Name & Degree

Paula Cunningham

Phone

203-785-3547

Email

paula.cunningham@yale.edu

12. IPD Sharing Statement

Plan to Share IPD

No

Learn more about this trial

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

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