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NCT Number: NCT04135846

Alpha-1 Blockade for Alcohol Use Disorder (AUD)

The goal of this research is to replicate findings previously conducted in a pilot trial and to understand, mechanistically, the role of stress in the development of AUD pharmacotherapies that target noradrenergic blockade.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Brown University

Providence, Rhode Island, 20923, United States

Location status: Recruiting

Location contact

Zoe Brown

CONTACT

401-863-6646

About this study

16 week, between-subject, double-blind, randomized clinical trial (RCT) with doxazosin (16 mg, or maximum tolerated dose, MTD) compared to placebo in 184 treatment seeking individuals with AUD

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female, 18 years of age
  • Meet the DSM-5 criteria for AUD
  • Desire to reduce or quit alcohol drinking
  • Breath alcohol (BrAC) = 0.00 at each visit
  • In good health as confirmed by medical history, physical examination and lab tests
  • Willing to adhere to the study procedures
  • Understand informed consent and questionnaires in English at an 8th grade level

Exclusion criteria

  • Women who are breastfeeding or /positive urine test for pregnancy
  • CrCl<60mL/min
  • Suicide attempt in the last three months
  • Current diagnosis of other substance disorder other than nicotine as assessed by self-report and urine toxicology screen at baseline
  • Current use of medication that may interact with doxazosin and/or yohimbine
  • History of allergy to any alpha receptor blockers
  • Clinical Institute Withdrawal Assessment for Alcohol revised (CIWA-Ar) score ≥ 8
  • Treatment with disulfiram, naltrexone, acamprosate, topiramate within 1 month prior to screening
  • Treatment with any alpha-blocker
  • Individuals with cardiac heat failure (CHF), as assessed by the medical history, the physical exam and the ECG.
  • Baseline hypotension defined as BP reading lower than 90/60 mmHg
  • Use of phosphodiesterase inhibitors (PDE5) erectile dysfunction medication

Treatment and study plan

Doxazosin

Drug

16 mg or maximum tolerated dose (MTD)

Other names: Cardura

Placebo

Drug

Matching placebo

Primary outcomes

  1. Alcohol consumption

    Time frame: 6 weeks

    Number of drinks per week (DPW) in naturalistic condition as measured by the timeline follow-back (TLFB)

Secondary outcomes

  1. Alcohol craving

    Time frame: one day

    We will measure alcohol craving using the Alcohol Craving Questionnaire (ACQ) after a cue-reactivity

  2. Alcohol craving

    Time frame: six weeks

    Alcohol craving in naturalistic condition will be measured using craving the Obsessive Compulsive Drinking Scale (OCDS)

Study contacts

Contact information is provided by the study sponsor or research team.

Zoe L Brown, BA

CONTACT

[email protected]

401-863-6646

Sponsors and collaborators

Lead sponsor

Brown University

Other

Registry information

Official study title

A Focus on Alpha-1 Blockade as a Novel Pharmacological Treatment for AUD

Acronym: DOXY

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Oct 23, 2019
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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