NCT04135846

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
184

participants targeted

Target at P75+ for phase_2

Timeline
4mo left

Started Dec 2019

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Dec 2019Aug 2026

First Submitted

Initial submission to the registry

October 21, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 23, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

December 19, 2019

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

March 20, 2026

Status Verified

September 1, 2025

Enrollment Period

6.7 years

First QC Date

October 21, 2019

Last Update Submit

March 18, 2026

Conditions

Alcohol Use Disorder (AUD)

Keywords

Alcohol use disorder, stress

Outcome Measures

Primary Outcomes (1)

  • Alcohol consumption

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

    6 weeks

Secondary Outcomes (2)

  • Alcohol craving

    one day

  • Alcohol craving

    six weeks

Study Arms (2)

doxazosin

EXPERIMENTAL

16 mg, or maximum tolerated dose (MTD)

Drug: Doxazosin

placebo

PLACEBO COMPARATOR

matching placebo

Drug: Placebo

Interventions

DoxazosinDRUG

16 mg or maximum tolerated dose (MTD)

Also known as: Cardura
doxazosin
PlaceboDRUG

Matching placebo

placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brown University

Providence, Rhode Island, 20923, United States

RECRUITING

Related Publications (2)

  • Haass-Koffler CL, Goodyear K, Zywiak WH, Magill M, Eltinge SE, Wallace PM, Long VM, Jayaram-Lindstrom N, Swift RM, Kenna GA, Leggio L. Higher pretreatment blood pressure is associated with greater alcohol drinking reduction in alcohol-dependent individuals treated with doxazosin. Drug Alcohol Depend. 2017 Aug 1;177:23-28. doi: 10.1016/j.drugalcdep.2017.03.016. Epub 2017 May 16.

    PMID: 28551590RESULT

  • Kenna GA, Haass-Koffler CL, Zywiak WH, Edwards SM, Brickley MB, Swift RM, Leggio L. Role of the alpha1 blocker doxazosin in alcoholism: a proof-of-concept randomized controlled trial. Addict Biol. 2016 Jul;21(4):904-14. doi: 10.1111/adb.12275. Epub 2015 Jun 2.

    PMID: 26037245RESULT

MeSH Terms

Conditions

Alcoholism

Interventions

Doxazosin

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PrazosinQuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Carolina L Haass-Koffler, PHARMD, PHD

    Brown University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zoe L Brown, BA

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 21, 2019

First Posted

October 23, 2019

Study Start

December 19, 2019

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

March 20, 2026

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)