Orexin Receptor Antagonists as Modulators of Threat Sensitivity in Individuals With Alcohol Use Disorder
Status:
Recruiting
Trial end date:
2024-12-01
Target enrollment:
Participant gender:
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).