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RECRUITING
NCT04793685
PHASE2

Prazosin for Alcohol Use Disorder With Withdrawal Symptoms

Sponsor: Yale University

View on ClinicalTrials.gov

Summary

This is a Phase 2 single site randomized clinical trial (RCT) to be supported by a new NIH-NIAAA grant, R01-AA029113-01, to assess the efficacy of Prazosin (16mg/day) versus Placebo over a 12 week treatment period, followed by a 1- and 3- month assessments post-treatment for individuals with Alcohol Use Disorder (AUD) and history of past or current evidence of alcohol withdrawal symptoms. If medical detoxification is required for any patient, patients would be enrolled after medical detoxification. for those not requiring detoxification, they will be enrolled directly without any requirement of alcohol abstinence. All patients will be provided behavioral counseling weekly with a trained counselor to support recovery during the trial. Primary outcome will be percent of any heavy drinking days and secondary drinking outcomes will be percent of subjects with no heavy drinking days (PSNHDD), avg drinks per drinking day and %of any drinking drinking days as well as additional secondary outcomes of craving, mood and anxiety problems.

Official title: Prazosin Treatment for Alcohol Use Disorder With Alcohol Withdrawal Symptoms

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2021-07-01

Completion Date

2027-06-30

Last Updated

2025-12-11

Healthy Volunteers

No

Interventions

DRUG

Prazosin

Prazosin (16mg/day) versus Placebo comparator, with a 2 week titration period, 9 weeks at full dose and a 5-day taper in week 12.

BEHAVIORAL

12-Step Facilitation with Relapse Prevention and Contingency Management

12-Step Facilitation and relapse prevention weekly support and Contingency Management for each weekly appointment to support treatment attendance for all subjects.

Locations (2)

The Yale Stress Center: Yale University

New Haven, Connecticut, United States

The Yale Stress Center: Yale University

New Haven, Connecticut, United States