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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: Completed Early Phase 1 study of Alcohol Use Disorder, sponsored by Ohio State University.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Startle EMG responses were collected during the well-validated No-Predictable-Unpredictable threat paradigm. The task includes within-subjects conditions and raw EMG responses were averaged for each condition. To quantify the difference between threat and no-threat periods, we calculated a standardized residual score for unpredictable threat (U-threat) by saving the variance leftover (i.e., the amount of variability in a dependent variable \[DV\] that is not explained by an independent variable
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Suvorexant
Study Locations (1)
Ohio
- The Ohio State University - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2022-11-29 |
| Est. Completion | 2024-08-01 |
| Phase | Early Phase 1 |
What the finished NCT05656534 record still lists
NCT05656534 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, below the 328-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (75% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Alcohol Use Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05656534's enrollment target sits among peer trials
81 99th of 184 higher than 86 of 184 other Alcohol Use Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alcohol Use Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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