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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 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

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%

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor

1,848 Previous Clinical Trials

2,737,668 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an ongoing recruitment process for this trial?

"Affirmative. Clinicaltrials.gov stipulates that this clinical trial is actively searching for participants; it was initially posted on July 1st 2021 and revised most recently on January 13th 2022. It seeks to enrol a total of 150 individuals between one site."

Answered by AI

How many participants are currently involved in this clinical exploration?

"Yes, according to clinicaltrials.gov, this medical study is actively seeking participants since its posting on July 1st 2021 and most recent update on January 13th 2022. The research requires 150 people from a single site."

Answered by AI

What therapeutic purposes does Prazosin commonly serve?

"Prazosin has been used to treat the symptoms of post-traumatic stress disorder, hypertension, and nightmares."

Answered by AI

Are there any historical precedents for using Prazosin in therapeutic treatments?

"At present, 7 trials exploring Prazosin are ongoing. One of these is in its concluding Phase 3. Although most testing for this drug occurs in Seattle, Washington, 9 sites across the US are participating in research on it."

Answered by AI