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

Yale University

Status and phase: Active, not recruiting; Phase 2

Conditions: Alcohol Drinking

Treatments: Drug: Propranolol; Drug: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03588754

2000022090

R01AA022285 (U.S. NIH Grant/Contract)

1U54AA027989-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups, including a placebo group

Propranolol

Experimental group

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.

Treatment:

Drug: Propranolol

Placebo

Placebo Comparator group

Description:

Administered orally once daily at 10:00PM

Treatment:

Drug: Placebo