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NCT05656534 · ClinicalTrials.gov registry record · Early Phase 1

Orexin Receptor Antagonists as Modulators of Threat Sensitivity in Individuals With Alcohol Use Disorder

A Early Phase 1 study of Alcohol Use Disorder, sponsored by Ohio State University.

Completed
Registry status
Early Phase 1
Development phase
81
Enrollment target
1
Study location

NCT05656534 is a Early Phase 1 study of Alcohol Use Disorder that has completed, run by Ohio State University. The registered enrollment target is 81 participants, below the 328-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (75% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT05656534, a Early Phase 1 study of Alcohol Use Disorder, has completed, sponsored by Ohio State University.

COMPLETED
Registry status
Early Phase 1
Development phase
81 participants
Enrollment target
1
Study location

Study Summary

The goal of this double-blind clinical trial is to further explore if, how, and for whom orexin antagonism modifies brain-behavior stress targets in moderate to severe alcohol use disorder (AUD). The main questions it aims to answer are: * Does an acute dose of suvorexant (SUV) and/or daily use of SUV modify brain-behavior targets of AUD dysfunction? * Does daily SUV use change alcohol behavior and if so, is this change in behavior linked to brain-behavior change? Participants will be randomized to a treatment group (SUV or placebo) and protocol arm, electromyography (EMG) only or EMG+functional magnetic resonance imaging (fMRI). Participants will be asked to complete the following: * Baseline lab visit(s) that include the psychophysiological stress paradigm (EMG only or EMG+fMRI, dependent upon randomization). * Acute drug challenge where the participant will return to the lab to repeat the stress paradigm following administration of a single dose of either 10mg SUV or placebo. * Medication trial where participants will be instructed to take 10mg capsules of SUV or placebo orally each night before bedtime for 4-weeks. * Daily reports of medication adherence, side-effects, sleep, alcohol use, and mood will be collected via smartphones during the 4-week medication trial. * Post-treatment lab visit(s) where participants will return to the lab at the end of the medication trial and complete the same stress paradigm from baseline (EMG only or EMG+fMRI, dependent upon randomization).

Conditions Studied

Alcohol Use Disorder

Interventions

  • OTHER Placebo
  • DRUG Suvorexant

Study Locations (1)

Ohio

  • The Ohio State University - Columbus

Trial Details

FieldValue
Enrollment Target 81 participants
Start Date 2022-11-29
Est. Completion 2024-08-01
Phase Early Phase 1

Sponsor

Ohio State University

552 total trials

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What the Registry Record Tells You About NCT05656534

The ClinicalTrials.gov registry entry for NCT05656534 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 81 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 328-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (75% lower). The listed sponsor is Ohio State University, which has 552 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Alcohol Use Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT05656534 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.

Frequently Asked Questions

What is clinical trial NCT05656534 about?

NCT05656534 is a clinical study titled "Orexin Receptor Antagonists as Modulators of Threat Sensitivity in Individuals With Alcohol Use Disorder". The goal of this double-blind clinical trial is to further explore if, how, and for whom orexin antagonism modifies brain-behavior stress targets in moderate to severe alcohol use disorder (AUD). The main questions it aims to answer are: * Does an acute dose of suvorexant (SUV) and/or daily use of ...

What is the current status of trial NCT05656534?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 81 participants. The study started on 2022-11-29. Estimated completion is 2024-08-01.

What conditions does trial NCT05656534 study?

This clinical trial studies the following conditions: Alcohol Use Disorder.

What interventions are being tested in trial NCT05656534?

The interventions under investigation include: Placebo (OTHER), Suvorexant (DRUG).

Who is sponsoring clinical trial NCT05656534?

This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05656534 being conducted?

This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.