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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03588754
Other study ID # 2000022090
Secondary ID R01AA022285U54AA
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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