RecruitingPhase 2NCT04793685

Prazosin for Alcohol Use Disorder With Withdrawal Symptoms

Prazosin Treatment for Alcohol Use Disorder With Alcohol Withdrawal Symptoms


Sponsor

Yale University

Enrollment

150 participants

Start Date

Jul 1, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a behavioral approach called 12-Step Facilitation with Relapse Prevention and Contingency Management and a drug called Prazosin for people with alcohol withdrawal. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years to 70 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPrazosin

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.

BEHAVIORAL12-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

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NCT04793685


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