NCT04793685

Prazosin for Alcohol Use Disorder With Withdrawal Symptoms

Prazosin Treatment for Alcohol Use Disorder With Alcohol Withdrawal Symptoms

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

In this Phase 2 single site RCT, individuals with moderate to severe alcohol use disorder (AUD) and presence of 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 mg /day Prazosin (PR) or Placebo (PBO) with a 2 week titration period and9-week full dose period and week 12 taper. All subjects will be assessed 2X weekly and also provided weekly behavioral counseling to support recovery.

Conditions

• Alcohol Withdrawal

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-07-01
• Primary completion: 2026-06-30
• Completion: 2027-06-30
• First posted: 2021-03-11
• Last updated: 2025-12-11

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study