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Alpha-1 Blocker

Doxazosin for Alcohol Use Disorder (DOXY Trial)

Phase 2
Recruiting
Led By Carolina L Haass-Koffler, PHARMD
Research Sponsored by Brown University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female, 18 to 70 (inclusive) years of age
Be older than 18 years old
Must not have
Individuals with cardiac heat failure (CHF), as assessed by the medical history, the physical exam and the ECG
Use of phosphodiesterase inhibitors (PDE5) erectile dysfunction medication
Timeline
Screening 3 weeks
Treatment Varies
Follow Up six weeks

Summary

This trial is looking to see if a certain drug can help people with Alcohol Use Disorder, by reducing stress.

Who is the study for?
This trial is for men and women aged 18-70 who have been diagnosed with Alcohol Use Disorder (AUD) according to DSM-5, want to cut down or stop drinking alcohol, are in good health based on medical checks, and can understand English at an 8th grade level. Pregnant or breastfeeding women, individuals with certain health conditions like kidney problems or heart failure, those who've attempted suicide recently, or people taking conflicting medications cannot participate.
What is being tested?
The study is testing the effectiveness of Doxazosin (an alpha-1 blocker) compared to a placebo in treating AUD. It aims to confirm previous pilot results and explore how stress affects the development of treatments that target specific nervous system pathways involved in AUD.
What are the potential side effects?
Doxazosin may cause side effects such as low blood pressure, dizziness, fatigue, headache and possibly fainting. Since it's being tested against a placebo which has no active ingredients, any additional side effects would be identified during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 70 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with heart failure.
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I am currently using medication for erectile dysfunction.
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My kidney function is reduced.
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I am currently taking medication that relaxes my blood vessels.
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I am currently breastfeeding or have tested positive for pregnancy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 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
Alcohol consumption
Secondary study objectives
Alcohol craving

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: doxazosinExperimental Treatment1 Intervention
16 mg, or maximum tolerated dose (MTD)
Group II: placeboPlacebo Group1 Intervention
matching placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Doxazosin
1995
Completed Phase 4
~42280

Find a Location

Who is running the clinical trial?

Brown UniversityLead Sponsor
466 Previous Clinical Trials
698,886 Total Patients Enrolled
34 Trials studying Alcoholism
7,540 Patients Enrolled for Alcoholism
Carolina L Haass-Koffler, PHARMDPrincipal InvestigatorBrown University
1 Previous Clinical Trials
34 Total Patients Enrolled
1 Trials studying Alcoholism
34 Patients Enrolled for Alcoholism
Carolina L Haass-Koffler, PHARMD, PHDPrincipal InvestigatorBrown University

Media Library

Doxazosin (Alpha-1 Blocker) Clinical Trial Eligibility Overview. Trial Name: NCT04135846 — Phase 2
Alcoholism Research Study Groups: placebo, doxazosin
Alcoholism Clinical Trial 2023: Doxazosin Highlights & Side Effects. Trial Name: NCT04135846 — Phase 2
Doxazosin (Alpha-1 Blocker) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04135846 — Phase 2
~33 spots leftby Dec 2025
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