Testing Doxazosin to Treat Stress Mechanisms in Alcoholism

NCT02989493 | Completed Phase 2 Results FDA Drug

• 5 other identifiers: 2015-1009R01AA024388A487400L&S\PSYCHOLOGY\PSYCHOLOGYProtocol Version 11/7/2019
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alcoholism

Keywords

Alcoholism; Stress; Norepinephrine; Doxazosin; Anxiety; Startle Potentiation; Relapse; Adrenergic Antagonists; Surrogate Endpoint

Outcome Measures

Primary Outcomes (2)

• Startle Potentiation During Stress Reactivity Task

  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.

  4 weeks

• Number of Participants Reporting Any Heavy Drinking Days

  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

  8 weeks

Study Arms (2)

Doxazosin

EXPERIMENTAL

Participants receive 8 weeks of doxazosin (8mg target dose).

Drug: Doxazosin

Placebo

PLACEBO COMPARATOR

Participants will receive 8 weeks of matched placebo.

Other: Placebo

Interventions

Doxazosin DRUG

Doxazosin

Doxazosin

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

You may not qualify if:

• 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 \[Clinical Institute Withdrawal Assessment for Alcohol, revised (CIWA-Ar) Score \> 10, or positive for any 'visual, auditory or tactile disturbances,' or for 'orientation and clouding of sensorium'\]

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53706, United States

Location

Related Links

• Dr. John Curtin's Addiction Research Center

MeSH Terms

Conditions

Alcoholism; Anxiety Disorders; Recurrence

Interventions

Doxazosin

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prazosin; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: John Curtin
• Organization: University of Wisconsin

jjcurtin@wisc.edu

608-262-0387

Study Officials

• John J Curtin, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2016
• First Posted: December 12, 2016
• Study Start: April 12, 2017
• Primary Completion: March 13, 2020
• Study Completion: March 13, 2020
• Last Updated: March 18, 2021
• Results First Posted: March 18, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)