Alcohol Drinking
Conditions
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.
Interventions
DRUGPropranolol
Propranolol Extended Release (160mg/day).
DRUGPlacebo
Placebo pill administered orally.
Sponsors
Yale University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSherry McKee, PhD
Professor
Outcome results
None listed