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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

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 weeks

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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have a severe mental health condition that needs specific treatment or medication.

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My sitting blood pressure is below 100/50 mmHg.

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I am currently using opioids or have a history of opioid addiction.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percent of Subjects with no Heavy Drinking Days

Secondary study objectives

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%

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

~1450

0 / 3Eligibility criteria met