Alpha-1 Blockade for Alcohol Use Disorder (AUD)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

184 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-19

Study Completion Date

2025-12-20

Brief Summary

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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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Detailed Description

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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

Conditions

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Alcohol Use Disorder (AUD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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doxazosin

16 mg, or maximum tolerated dose (MTD)

Group Type EXPERIMENTAL

Doxazosin

Intervention Type DRUG

16 mg or maximum tolerated dose (MTD)

placebo

matching placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo

Interventions

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Doxazosin

16 mg or maximum tolerated dose (MTD)

Intervention Type DRUG

Placebo

Matching placebo

Intervention Type DRUG

Other Intervention Names

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Cardura

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No