Clinical Trial: Repurposing alpha1 Noradrenergic Antagonists for Alcoholism Treatment

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Repurposing alpha1 Noradrenergic Antagonists for Alcoholism Treatment

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.

Detailed Summary:

OBJECTIVES

The first objective of the current study is to examine norepinephrine alpha1 (NE-alpha1) receptor involvement in reactivity to unpredictable stressors in humans, by using the NPU stress task in conjunction with an alpha1-blocker, prazosin. The second objective of the study is to provide preliminary evidence that prazosin is effective at reducing stress-reactivity in alcoholics in early abstinence.

PARTICIPANTS

Sixty-four healthy adult participants and sixty-four participants with an Alcohol Use Disorder in early abstinence.

STUDY OVERVIEW

Sixty-four healthy adult participants (32 males & 32 females) will be recruited to participate in a double-blind, placebo-controlled, cross-over design study examining the effects of a NE-alpha1 antagonist (prazosin) on the defensive (physiological and self-report affect) response to stressors using a well-validated animal-human translational stressor task. Participants will complete two overnight study visits where 2 mg prazosin and placebo are administered on separate visits separated by approximately 7 days. Drug order is randomly assigned and counterbalanced across participants (double-blind; study visits 1-2). On each of these two study visits, participants will complete the No Shock, Predictable Shock, Unpredictable Shock (NPU) task 90 minutes after drug administration. The NPU task is designed to examine stress reactivity to predictable and unpredictable stressors (i.e., electric shock). These two visits provide for a within-subject evaluation of the effect of acute antagonism of alpha1-NE receptors (via prazosin) to investigate the role of this NE mechanism in unpredictable (vs. predictable) stressor response.

Sponsor: University of Wisconsin, Madison

Current Primary Outcome: Startle potentiation during stress reactivity task. [ Time Frame: 7 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Self-reported anxiety during stress reactivity task. [ Time Frame: 7 days ]

Original Secondary Outcome: Same as current

Information By: University of Wisconsin, Madison

Dates:
Date Received: November 15, 2016
Date Started: November 2016
Date Completion: December 2019
Last Updated: November 29, 2016
Last Verified: November 2016