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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up six weeks

Awards & highlights

DOXY Trial 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.Check my eligibility

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.See study design

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.

DOXY Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 70 years old.

DOXY Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Alcohol consumption

Secondary outcome measures

Alcohol craving

DOXY 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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Brown UniversityLead Sponsor

456 Previous Clinical Trials

562,897 Total Patients Enrolled

29 Trials studying Alcoholism

5,331 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

Frequently Asked Questions

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

What safety measures should be taken when utilizing Doxazosin?

"There is some evidence of Doxazosin's safety, so it was assigned a rating 2 on our scale. Unfortunately, there are no studies that demonstrate its efficacy yet."

Answered by AI

How many individuals are participating in this research?

"Affirmative, the clinical trial is looking for enrollees. The study was first posted on December 19th 2019 and its progress was last updated eighteen days ago - July 18th 2022. 184 patients are needed to be recruited from a single location."

Answered by AI

Am I an eligible candidate to join this research endeavor?

"This clinical trial is looking for 184 people living with alcohol dependency, ranging between 18 and 70 years old. Ideal candidates should be able to comprehend English on an 8th grade level, satisfy the DSM-5 criteria for AUD (Alcohol Use Disorder), have a breath alcohol concentration of 0.00 at each visit, remain in good physical health as certified by medical tests, agree to adhere to study protocols, and desire to reduce or stop drinking altogether."

Answered by AI

Is recruitment still open for this clinical experiment?

"Per the information on clinicaltrials.gov, enrolment for this investigation is still open. This experiment was inaugurated on December 19th 2019 and its particulars were last updated on July 18th 2022."

Answered by AI

Is there precedent for research involving Doxazosin?

"Presently, there are seven active medical trials that investigate Doxazosin with two of them in their final phase. Oklahoma City is the primary hub for these studies; however, 36 other locations have administrative roles as well."

Answered by AI

Does the trial require applicants to be over 25 years of age?

"Patients eligible to take part in this trial must be between 18 and 70 years old. Separately, there are 34 clinical trials for minors aged below 18, as well as 255 studies available for older persons above 65."

Answered by AI