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Prazosin for Alcohol Use Disorder With Withdrawal Symptoms
Sponsor: Yale University
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
Conditions
Interventions
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.
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