Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID04135846

A Focus on Alpha-1 Blockade as a Novel Pharmacological Treatment for Alcohol Use Disorder

Led by Brown University · Updated on 2026-03-20

184

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the role of stress in the development of treatments for Alcohol Use Disorder (AUD) by studying the effects of alpha-1 receptor blockade. This research aims to replicate findings from an earlier pilot trial and focuses on doxazosin as a potential pharmacological treatment. The trial is a Phase 2, randomized, double-blind clinical study involving 184 individuals seeking treatment for AUD. Participants will be randomly assigned to receive either doxazosin at 16 mg or the maximum tolerated dose, or a matching placebo, over a 16-week period. The study uses a quadruple-blind design to compare the effects of the drug to placebo. The dosing is carefully monitored to ensure safety and adherence. During the study, participants will have regular visits to assess alcohol consumption, craving, and other health factors. The primary outcome measure is alcohol consumption at 6 weeks, while secondary measures include alcohol craving assessed both one day and six weeks after treatment begins. Safety and adherence are monitored through medical history, physical exams, lab tests, and breath alcohol checks. The total participation duration is 16 weeks, with thorough follow-up throughout the trial.

CONDITIONS

Brief Title

Alpha-1 Blockade for Alcohol Use Disorder (AUD)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female, 18 years of age or older
  • Meet the DSM-5 criteria for Alcohol Use Disorder
  • Desire to reduce or quit alcohol drinking
  • Breath alcohol concentration (BrAC) of 0.00 at each visit
  • In good health confirmed by medical history, physical exam, and lab tests
  • Willing to follow all study procedures
  • Understand informed consent and questionnaires in English at an 8th grade level
Not Eligible

You will not qualify if you...

  • Women who are breastfeeding or have a positive urine pregnancy test
  • Creatinine clearance (CrCl) less than 60 mL/min
  • Suicide attempt in the last three months
  • Current diagnosis of any substance disorder other than nicotine
  • Current use of medications that may interact with doxazosin or yohimbine
  • History of allergy to any alpha receptor blockers
  • Clinical Institute Withdrawal Assessment for Alcohol revised (CIWA-Ar) score 8 or higher
  • Treatment with disulfiram, naltrexone, acamprosate, topiramate within 1 month prior to screening
  • Treatment with any alpha-blocker
  • History of cardiac heart failure
  • Baseline hypotension defined as blood pressure lower than 90/60 mmHg
  • Use of phosphodiesterase inhibitors for erectile dysfunction

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 16 weeks

Participants receive doxazosin or placebo medication for Alcohol Use Disorder.

Weekly visits for up to 16 weeks

Trial Site Locations

Total: 1 location

1

Brown University

Providence, Rhode Island, United States, 20923

Actively Recruiting

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Research Team

Z

Zoe L Brown, BA

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Higher pretreatment blood pressure is associated with greater alcohol drinking reduction in alcohol-dependent individuals treated with doxazosin.

Carolina L Haass-Koffler, Kimberly Goodyear, William H Zywiak...

https://pubmed.ncbi.nlm.nih.gov/28551590