Prazosin for Alcohol Use Disorder with Withdrawal Symptoms

Phase 2

Recruiting

• Conditions: Alcohol Withdrawal
• Interventions: Drug: Prazosin; Behavioral: 12-Step Facilitation with Relapse Prevention and Contingency Management

• Registration Number: NCT04793685
• Lead Sponsor: Yale University

Brief 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 outcomes will be percent of subjects no heavy drinking days (PSNHDD) and %of any drinking and heavy drinking days as well as secondary outcomes of craving, mood, anxiety and sleep problems.

Detailed Description

In this Phase 2 single site RCT, individuals with moderate to severe alcohol use disorder (AUD) and presenc eof alcohol withdrawal symptoms (greater than 3 symptoms or more) will be enrolled in a 12 week trial with a 1- and 3- month follow up assessment. Subjects will be randomized to 16 mh /day Prazosin (PR) or Placebo (PBO) with a 2 week titration period and week 12 taper. All subjects will be assessed 2X weekly and also provided weekly behavioral counseling to support recovery.

Study Timeline

• Study First Submitted: 2021-03-03
• Study First Submitted QC: 2021-03-09
• Study First Posted: 2021-03-11
• Study Start: 2021-07-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-21
• Primary Completion: 2026-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Alcohol Withdrawal (AW) scores of 3 or more on the CIWA-Ar at treatment entry and regular weekly use of alcohol at least 3X weekly or more 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 Criteria

• Meet current criteria for moderate to severe substance use disorders from use of any another psychoactive substance, excluding nicotine;
• Current use of opioids or past history of opioid use disorder;
• Regular use of anticonvulsants, sedatives/hypnotics, oral prescription analgesics (other than noon-steroidal antiinflammatory drugs), other antihypertensives, anti-arrythmics, antiretroviral medications, tricyclic antidepressants, acamprosate, naltrexone, antabuse, topiramate, gabapentin, baclofen, varenicline;
• 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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Drug	12-Step Facilitation with Relapse Prevention and Contingency Management	Prazosin (16mg/day) versus Placebo comparator, administered in t.i.d schedule, in capsules, over a 12 week period, with 2 weeks titration in weeks 1-2 and a 5-day taper in week 12.
Placebo Drug	12-Step Facilitation with Relapse Prevention and Contingency Management	Placebo for 12 weeks.
Active Drug	Prazosin	Prazosin (16mg/day) versus Placebo comparator, administered in t.i.d schedule, in capsules, over a 12 week period, with 2 weeks titration in weeks 1-2 and a 5-day taper in week 12.

Primary Outcome Measures

Name	Time	Method
Percent of Subjects with no Heavy Drinking Days	up to 12 weeks	Prazosin versus Placebo treated subjects will be compared on any days of heavy drinking which is defined by 5 or more drinks per day in men and 4 or more drinks/day in women. This will be measured by the Percent of Subjects with no Heavy Drinking Days (PSNHDD) over a 12 week period.

Secondary Outcome Measures

Name	Time	Method
Percent Heavy Drinking Days	up to 12 weeks	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).
Percent Any Drinking Days	up to 12 weeks	Percent of any drinking days over a 12 week period.
Average Drinks per Day	up to 12 weeks	The average number of drinks consumed per day assessed weekly over the treatment period.

Trial Locations

Locations (1)

The Yale Stress Center: Yale University; 🇺🇸 New Haven, Connecticut, United States