Prazosin for Alcohol Use Disorder with Withdrawal Symptoms

This study is testing if a medication called Prazosin, along with weekly counseling and support, can help people with alcohol use disorder (AUD) who also experience alcohol withdrawal symptoms. You would either receive Prazosin (16mg/day) or a placebo (an inactive pill). All participants will also get weekly behavioral counseling, which includes 12-Step Facilitation, relapse prevention, and support for attending appointments. The main goal is to see if Prazosin helps reduce heavy drinking days over a 12-week period. You might be able to join if you are 18 to 70 years old, have moderate to severe AUD, and experience alcohol withdrawal symptoms. The current recruitment status is unclear.

Study design: This is a Phase 2 randomized clinical trial, meaning participants are randomly assigned to receive Prazosin or a placebo. It plans to enroll 150 participants.
What's involved: You would take Prazosin or placebo for 12 weeks, with a 2-week ramp-up, 9 weeks at full dose, and a 5-day taper. You would also have assessments twice a week and weekly behavioral counseling.
Compensation: Not stated in the trial record.
Follow-up: Participants will have follow-up assessments 1 month and 3 months after the 12-week treatment period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Prazosin for Alcohol Use Disorder With Withdrawal Symptoms

Recruiting

PHASE2Ages 18–70InterventionalTreatment

Yale University

~150 participants

Updated 2025-12-11 on ClinicalTrials.gov

What's tested:Prazosin12-Step Facilitation with Relapse Prevention and Contingency Management

At a glance

Recruiting sites

2 of 2 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Percent Heavy Drinking Days

Measured over weeks 3 - 12 of full dose treatment

Conditions

Alcohol Withdrawal

Where it's being run

2 sites across 1 states

Connecticut2

Study leadership

David Fiellin, MD · STUDY_DIRECTOR · Yale University
Gretchen Hermes, MD · STUDY_DIRECTOR · Yale University

Who to contact

RAJITA SINHA, PhD

[email protected]

12038592840

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Alcohol Withdrawal (AW) scores of 3 or more on the CIWA-Ar at treatment entry OR 2 or more Alcohol Withdrawal Syndrome (AWS) symptoms and regular weekly heavy drinking at treatment entry;

Must meet current DSM-5 criteria for moderate to severe Alcohol Use Disorder (AUD) using SCID-I for DSM-5;

No health conditions that would impact trial participation as verified by screening and physical examination;

Able to read English and complete study evaluations

Able to provide informed written and verbal consent.

Exclusion

Meet current criteria for moderate to severe substance use disorders from use of any another psychoactive substance, excluding nicotine, cocaine and cannabis;

Current use of illicit /non-prescribed opioids more than 2X/month;

Regular use of anticonvulsants, sedatives/hypnotics, oral prescription analgesics (other than non-steroidal anti-inflammatory drugs), antiretroviral medications, tricyclic antidepressants, topiramate, baclofen, and regular weekly use of benzodiazepines, as defined by use of three or more times per week;

Prescribed use of antihypertensive medications that duplicate the mechanism of action at the alpha1 receptor as prazosin or are contraindicated, such as those medications that are also alpha1-adrenergic antagonists (i.e., doxazosin, tamsulosin, terazosin) or are beta-blockers (e.g., propranolol); Potential participants who are prescribed cardiovascular/antihypertensive medications will undergo clinical review by the study PIs and team. Individuals who are prescribed anti-hypertensives that do not duplicate the action of prazosin and are not contraindicated, including ACE inhibitors, angiotensin receptor blockers (ARBs), diuretics, and calcium channel blockers, may be allowed to participate after review from the study physician and principal investigators, with careful monitoring of these individuals' blood pressure at all in-person appointments.

Psychotic or otherwise severely psychiatrically disabled (i.e., suicidal, homicidal, current mania);

Significant underlying medical conditions such as cerebral, renal, thyroid or cardiac pathology which in the opinion of study physician would preclude patient from fully cooperating or be of potential harm during the course of the study;

Any psychotic disorder or current Axis I psychiatric disorders requiring specific attention, including need for psychiatric medications;

Hypotensive individuals with sitting blood pressure below 100/50 mmHG;

Women who are pregnant, nursing or refuse to use a reliable form of birth control (as assessed by pregnancy tests during initial medical evaluation, and assessed every two weeks during the course of the study).

What this trial measures

Percent Heavy Drinking Daysweeks 3 - 12 of full dose treatment
Percent of overall days with heavy drinking days (defined by 5 or more drinks per day in men and 4 or more drinks/day in women) after achieving full treatment dose in week 3.

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