Repurposing alpha1 Noradrenergic Antagonists for Alcoholism Treatment

NCT02966340 | Completed Phase 1 Results FDA Drug

• 3 other identifiers: 2014-0966F31AA022845-01Kaye2
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Double-blind, placebo-controlled, cross-over design study examining the effects of a norepinephrine alpha1 receptor antagonist (prazosin) on stress reactivity in a laboratory stressor task.

Conditions

Alcoholism

Keywords

Alcoholism; Prazosin; Startle Potentiation; Norepinephrine; Anxiety; Fear; Stress

Outcome Measures

Primary Outcomes (1)

• Startle Potentiation During Stress Reactivity Task.

  The unpredictable shock and predictable shock startle response potentiation (vs. no shock) during the administration of the NPU stressor task. Values represent point estimate of effect from unadjusted general linear model analyses with 95% confidence intervals

  7 days

Secondary Outcomes (1)

• Self-reported Anxiety Potentiation During Stress Reactivity Task.

  7 days

Study Arms (2)

Prazosin 1st visit, Placebo 2nd visit

EXPERIMENTAL

All participants receive 2mg prazosin and placebo in a cross-over design (e.g., one pill per visit). The order of prazosin vs placebo is counterbalanced between subjects (e.g., half participants receive prazosin at study visit 1 and half participants receive placebo at study visit 1).

Drug: Prazosin; Drug: Placebo

Placebo 1st visit, Prazosin 2nd visit

EXPERIMENTAL

All participants receive 2mg prazosin and placebo in a cross-over design (e.g., one pill per visit). The order of prazosin vs placebo is counterbalanced between subjects (e.g., half participants receive prazosin at study visit 1 and half participants receive placebo at study visit 1).

Drug: Prazosin; Drug: Placebo

Interventions

Prazosin DRUG

2mg Prazosin

Placebo 1st visit, Prazosin 2nd visit; Prazosin 1st visit, Placebo 2nd visit

Placebo DRUG

Placebo

Placebo 1st visit, Prazosin 2nd visit; Prazosin 1st visit, Placebo 2nd visit

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Can read and write in English.
• Ages of 18-50 years.
• No current or lifetime history of Substance Use Disorder (except tobacco).
• Current Alcohol Use Disorder with 1-8 weeks completely free from alcohol consumption.

You may not qualify if:

• Colorblind
• Blood alcohol concentration (BAC) \> 0.00
• Systolic BP \<100 after five minutes seated.
• Systolic BP drop \>20 mmHg after two minutes standing.
• Systolic BP drop \>10 mgHg AND report dizziness, lightheadedness, unsteadiness or other problems (e.g, nausea, blurry vision) after two minutes standing.
• Heart rate \>100 beats/ minute after two minutes seated.
• Heart rate \<60 beats/ minute after two minutes seated.
• Scheduled for cataract surgery prior to study completion.
• Past or current coronary artery disease, cerebrovascular accident, congestive heart failure.
• Current renal insufficiency, liver insufficiency, pancreatitis, immunosuppressive therapy, or cancer with systemic effects or therapy.
• Benign positional vertigo, Meniere's disease or narcolepsy
• Current diabetes or polyneuropathy
• Previous allergic or adverse reaction to prazosin or other alpha1 norepinephrine antagonist.
• Other self-reported acute or unstable illness that, in the opinion of the study team, would preclude a safe and reliable study participation.
• Non-negative urine pregnancy test.

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

Interventions

Prazosin

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: John J. Curtin
• Organization: UW Madison

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 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2016
• First Posted: November 17, 2016
• Study Start: November 1, 2016
• Primary Completion: March 12, 2018
• Study Completion: March 12, 2018
• Last Updated: May 28, 2019
• Results First Posted: May 28, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)