NCT02989493

Testing Doxazosin to Treat Stress Mechanisms in Alcoholism

Completed Phase 2 Results posted Last updated 18 March 2021

What this trial tests

Phase 2 trial testing Doxazosin in Alcoholism in 61 participants. Completed in 13 March 2020.

Timeline

12 April 2017

Primary endpoint
13 March 2020

13 March 2020

Quick facts

Lead sponsor	University of Wisconsin, Madison
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	61
Start date	12 April 2017
Primary completion	13 March 2020
Estimated completion	13 March 2020
Sites	1 location across United States

Drugs / interventions tested

• Doxazosin (DOXAZOSIN) — full drug profile →
• Placebo

Conditions studied

• Alcoholism — all drugs for Alcoholism →

Sponsor

University of Wisconsin, Madison

Who can join

Adults 18 to 65, any sex, with Alcoholism. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Startle Potentiation During Stress Reactivity Task Primary · 4 weeks

Startle potentiation is used to study anxiety and fear with No-shock, Predictable-shock, Unpredictable-shock (NPU) task; a common, well-validated laboratory stressor task. In the Predictable condition of the NPU task, shocks are 100 percent predictable and occur at a consistent, known time. In the Unpredictable condition of the NPU task, shocks are fully unpredictable. A higher score on startle potentiation means a higher stress reactivity response for the given condition.

Unpredictable startle potentiation

Group	Value	95% CI
Doxazosin	22.25	± 20.18
Placebo	20.76	± 23.21

Predictable startle potentiation

Group	Value	95% CI
Doxazosin	26.22	± 30.90
Placebo	22.21	± 35.93

Number of Participants Reporting Any Heavy Drinking Days Primary · 8 weeks

Timeline-followback (TLFB) was administered twice at 4 weeks and 8 weeks. Participants reported the number of drinks per day for each previous 30 day period. Any heavy drinking was scored "yes" if participant reported any days of heavy drinking (\> 4/3 standard drinks for men/women) during the total 8 week assessment period; "no" if no heavy drinking was reported

Group	Value	95% CI
Doxazosin	17
Placebo	21

Adverse events — posted to ClinicalTrials.gov

Time frame: 8 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Doxazosin

Serious: 0/29 (0%)

Deaths: 0/29

Placebo

Serious: 0/32 (0%)

Deaths: 0/32

Other adverse events (15 terms — click to expand)

Reaction	System	Doxazosin	Placebo
Fatigue	General disorders	—	—
Orthostatic hypertension	Vascular disorders	—	—
Rhinitis	General disorders	—	—
Headache	General disorders	—	—
Dry mouth	General disorders	—	—
Dizziness	Ear and labyrinth disorders	—	—
Nausea or diarrhea	Gastrointestinal disorders	—	—
Cardiac arrhythmia	Cardiac disorders	—	—
General symptoms, nonspecific	General disorders	—	—
Dyspnea	Respiratory, thoracic and mediastinal disorders	—	—
Blurry vision	Eye disorders	—	—
Polyurea	Renal and urinary disorders	—	—
Edema	Cardiac disorders	—	—
Chest pains	Cardiac disorders	—	—
Priapism	Reproductive system and breast disorders	—	—

Data from ClinicalTrials.gov NCT02989493 adverse events section.

Sponsor's own description

Double-blind, placebo controlled, randomized controlled trial (RCT) for Alcohol Use Disorder examining the effects of doxazosin, a norepinephrine alpha1 receptor antagonist, on stress reactivity and clinical outcomes.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Noradrenergic targets for the treatment of alcohol use disorder.
   Haass-Koffler CL, Swift RM, Leggio L. · · 2018 · cited 61× · PMID 29460163 · DOI 10.1007/s00213-018-4843-6