Alpha-1 Blockade for Alcohol Use Disorder (AUD) (DOXY)

July 7, 2023 updated by: Carolina Haass-Koffler, Brown University

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

184

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 20923
        • Recruiting
        • Brown University
        • Contact:
          • Zoe Brown
          • Phone Number: 401-863-6646

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
matching placebo
Drug: Placebo
Matching placebo
Experimental: doxazosin
16 mg, or maximum tolerated dose (MTD)
Drug: Doxazosin
16 mg or maximum tolerated dose (MTD)
Other Names:
  • Cardura

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alcohol craving
Time Frame: one day
We will measure alcohol craving using the Alcohol Craving Questionnaire (ACQ) after a cue-reactivity
one day
Alcohol craving
Time Frame: six weeks
Alcohol craving in naturalistic condition will be measured using craving the Obsessive Compulsive Drinking Scale (OCDS)
six weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brown University

Investigators

  • Principal Investigator: Carolina L Haass-Koffler, PHARMD, PHD, Brown University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2019

Primary Completion (Estimated)

December 20, 2024

Study Completion (Estimated)

December 20, 2024

Study Registration Dates

First Submitted

October 21, 2019

First Submitted That Met QC Criteria

October 21, 2019

First Posted (Actual)

October 23, 2019

Study Record Updates

Last Update Posted (Actual)

July 11, 2023

Last Update Submitted That Met QC Criteria

July 7, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1907002490

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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