Recruiting
Phase 2

Alpha-1 Blockade

Sponsor:

Brown University

Code:

NCT04135846

Conditions

Alcohol Use Disorder (AUD)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Doxazosin

Placebo

Study Details

Brief summary:

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.

Conditions

Alcohol Use Disorder (AUD)

Study ID

NCT04135846

Start date

Dec 19, 2019

Status verified date

Sep, 2025

Completion date

Aug 31, 2026

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

184 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: doxazosin

16 mg, or maximum tolerated dose (MTD)

placebo comparator: placebo

matching placebo

Interventions

Doxazosin

16 mg or maximum tolerated dose (MTD)

Placebo

Matching placebo

Primary outcome measure

  • Alcohol consumption [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Zoe L Brown, BA

401-863-6646alcohol.stress.study@brown.edu

Locations

Brown University

Recruiting

Providence, Rhode Island, United States, 20923

Contacts

Zoe Brown

401-863-6646

More Information

Sponsor

Brown University

Last update posted

Mar 20, 2026

Last verified

Sep, 2025

Keywords

  • Alcohol use disorder, stress

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brown University on 2026-03-20.