Testing Doxazosin to Treat Stress Mechanisms in Alcoholism

Completed · Phase 2 · Has a placebo group

Conditions studied: Alcoholism

In brief

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.

Key facts

Study ID

NCT02989493

Run by

University of Wisconsin, Madison

People needed

61

Starts

2017-04-12

Expected to finish

2020-03-13

Last updated by the study team

2021-03-18

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnostic and Statistical Manual (DSM-5) diagnosis of Alcohol Use Disorder, Moderate-Severe
• Alcohol abstinent for 1 - 8 weeks
• Ages of 18 to 65
• Exclusion criteria are divided into three broad categories of Medical, Psychiatric/Behavioral, and Medications/Therapies.
• EXCLUSION CRITERIA: Medical
• Blood alcohol concentration above 0.00.
• Color blind.
• Heart rate >100 beats per minute after five minutes seated.
• Heart rate <55 beats per minute after five minutes seated.
• Systolic BP <100 after five minutes seated.
• Systolic BP drop >20mm Hg or diastolic BP drop >10mm Hg after two minutes standing.
• Dizziness, lightheadedness, unsteadiness or other problems (e.g, nausea, blurry vision) after two minutes standing.
• Uncorrected auditory/vision problems.
• Current treatment for chronic pain condition.
• Past or current coronary artery disease, cerebrovascular accident, congestive heart failure.
• Current chronic renal insufficiency, liver insufficiency or moderate hepatic impairment, pancreatitis, immunosuppressive therapy, or cancer with systemic effects or therapy.
• Benign positional vertigo, Meniere's disease, or narcolepsy.
• Previous allergic or adverse reaction to doxazosin or other alpha1 noradrenergic antagonist.
• Scheduled or reported plans for cataract surgery prior to study completion.
• Currently symptomatic of alcohol withdrawal [Clinical Institute Withdrawal Assessment for Alcohol, revised (CIWA-Ar) Score > 10, or positive for any 'visual, auditory or tactile disturbances,' or for 'orientation and clouding of sensorium']
• Discharged from inpatient treatment for Alcohol Use Disorder or alcohol detoxification within past 7 days.
• Currently medically unstable.
• Electrocardiogram (ECG) clinical over-read indicates concerns of cardiac function.
• Other self-reported acute or unstable illness that, in the opinion of the study team, would preclude a safe and reliable study participation
• EXCLUSION CRITERIA: Female Participants Only

Where it is running

• University of Wisconsin — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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