Alpha-1 Blockade for Alcohol Use Disorder (AUD)

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04135846

Acronym

DOXY

Enrollment

184

Registered

2019-10-23

Start date

2019-08-19

Completion date

2026-12-31

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Use Disorder (AUD)

Keywords

Alcohol use disorder, stress

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.

Detailed description

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

Interventions

DRUGDoxazosin

16 mg or maximum tolerated dose (MTD)

DRUGPlacebo

Matching placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Alcohol consumption	6 weeks	Number of drinks per week (DPW) in naturalistic condition as measured by the timeline follow-back (TLFB)

Secondary

Measure	Time frame	Description
Alcohol craving	one day	We will measure alcohol craving using the Alcohol Craving Questionnaire (ACQ) after a cue-reactivity

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORCarolina L Haass-Koffler, PHARMD, PHD

Brown University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 15, 2026