Prazosin for Alcohol Use Disorder With Withdrawal Symptoms

Alcohol Withdrawal Clinical Trial

Official title: Prazosin Treatment for Alcohol Use Disorder With Alcohol Withdrawal Symptoms

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Alcohol Withdrawal
• Alcoholism
• Substance Withdrawal Syndrome

• NCT number: NCT04793685
• Study type: Interventional
• Source: Yale University
• Contact: RAJITA SINHA, PhD
• Phone: 12038592840
• Email: rajita.sinha@yale.edu
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: July 1, 2021
• Completion date: June 30, 2027