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Alpha-1 Adrenergic Receptor Antagonist

Prazosin for Alcohol Withdrawal

Phase 1 & 2
Recruiting
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 weeks
Awards & highlights

Study Summary

This trial is testing if prazosin, a medication typically used to treat high blood pressure, is effective in treating alcohol withdrawal symptoms and helping people with alcohol use disorder abstain from drinking. Patients will be randomly assigned to either take prazosin or a placebo pill for 12 weeks, and then will be monitored for 1- and 3-months after treatment. The primary outcome measures are the percentage of subjects who have no heavy drinking days, and the percentage of any drinking and heavy drinking days.

Who is the study for?
This trial is for individuals with moderate to severe Alcohol Use Disorder who experience withdrawal symptoms. Participants must be able to read English, have no other substance use disorders (except nicotine), and not be using certain medications like opioids or antihypertensives. They should not have severe psychiatric conditions or significant medical issues that could interfere with the study.Check my eligibility
What is being tested?
The trial tests Prazosin (16mg/day) against a placebo over 12 weeks in patients with Alcohol Use Disorder and withdrawal symptoms. It includes weekly behavioral counseling sessions. The main focus is on reducing heavy drinking days, along with monitoring craving, mood, anxiety, and sleep problems.See study design
What are the potential side effects?
Prazosin may cause side effects such as dizziness due to low blood pressure, especially when standing up quickly from sitting or lying down; it can also lead to drowsiness or headaches.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percent of Subjects with no Heavy Drinking Days
Secondary outcome measures
Average Drinks per Day
Percent Any Drinking Days
Percent Heavy Drinking Days

Side effects data

From 2017 Phase 4 trial • 20 Patients • NCT02199652
20%
fainting
10%
psychiatric hospitalization
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Prazosin

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active DrugExperimental Treatment2 Interventions
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.
Group II: Placebo DrugPlacebo Group1 Intervention
Placebo for 12 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prazosin
2010
Completed Phase 4
~1590

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,864 Previous Clinical Trials
2,742,115 Total Patients Enrolled
Gretchen Hermes, MDStudy DirectorYale University
David Fiellin, MDStudy DirectorYale University
7 Previous Clinical Trials
8,287 Total Patients Enrolled

Media Library

Prazosin (Alpha-1 Adrenergic Receptor Antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT04793685 — Phase 1 & 2
Alcohol Withdrawal Syndrome Research Study Groups: Active Drug, Placebo Drug
Alcohol Withdrawal Syndrome Clinical Trial 2023: Prazosin Highlights & Side Effects. Trial Name: NCT04793685 — Phase 1 & 2
Prazosin (Alpha-1 Adrenergic Receptor Antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04793685 — Phase 1 & 2
~61 spots leftby Jun 2026
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