Testing Doxazosin to Treat Stress Mechanisms in Alcoholism

• Status: Completed
• Trial end date: 2020-03-13
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Wisconsin, Madison
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Treatments: Doxazosin

Criteria

INCLUSION CRITERIA:

• 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

• Non-negative urine pregnancy test.

• Women of childbearing potential (see definition below) must agree to use one of the following forms of birth control until after study completion. Acceptable birth control is defined as the following methods of contraception: abstinence; hormonal contraceptives (e.g. combined oral contraceptives, patch, vaginal ring, injectables, and implants); intrauterine device (IUD) or intrauterine system (IUS); vasectomy of partner and tubal ligation; "single" barrier methods of contraception (e.g. male condom, female condom, cervical cap, diaphragm, contraceptive sponge) with use of spermicide; or "double barrier" method of contraception (e.g. male condom with diaphragm, male condom with cervical cap).

• Breastfeeding.

NOTE: Women of childbearing potential are females who have experienced menarche and do not meet the criteria for women not of childbearing potential. Women not of childbearing potential are females who are permanently sterile (e.g., hysterectomy, bilateral oophorectomy) or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause.

EXCLUSION CRITERIA: Psychological/Behavioral

• Self-reported lifetime diagnosis of schizophrenia, schizoaffective disorder, psychotic disorder not otherwise specified, bipolar disorder (with manic episode), borderline personality disorder, or any neurocognitive disorder that may impair a reliable, safe participation.

• Current suicidal ideation.

• Current active substance use disorder other than alcohol or tobacco.

EXCLUSION CRITERIA: Medications/Therapies

• Currently prescribed or used within past week: doxazosin or other alpha1 noradrenergic antagonist (e.g., prazosin, terazosin).

• Currently prescribed or used within past week: substances with stimulant properties (e.g., d-amphetamine, methylphenidate, ephedra, pseudoephedrine).

• Currently prescribed or used within past week: Sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra).

• Currently prescribed or used within past week: beta-blockers (e.g., propanolol), alpha2 agonists (e.g., clonidine, guanfacine, dexmedetomidine), and serotonin and norepinephrine reuptake inhibitors (SNRI) (e.g., venlafaxine, duloxetine, atomoxetine, viloxazine).

• Currently used daily or used within past week: alpha1 agonists (e.g., midodrine, metaraminol, oxymetazoline, phenylephrine).

• Currently used daily or used within past week: Benzodiazepines (e.g., diazepam, chlordiazepoxide, lorazepam, clonazepam, alprazolam), zolpidem (Ambien), zaleplon (Sonata), zopiclone (Imovane), eszopiclone (Lunesta), doxepin (Silenor).

• Currently prescribed and used daily or used within past 2 weeks: Trazodone.

• Currently prescribed or used within 2 weeks: Disulfiram (Antabuse).