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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-15

Study Completion Date

2026-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Alcohol Drinking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Propranolol

Intervention Type DRUG

Propranolol Extended Release (160mg/day).

Placebo

Administered orally once daily at 10:00PM

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo pill administered orally.

Interventions

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Propranolol

Propranolol Extended Release (160mg/day).

Intervention Type DRUG

Placebo

Placebo pill administered orally.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes