Suvorexant for Alcohol Use Disorder and Post-traumatic Stress Disorder: Study Protocol for a Phase II Randomized Clinical Trial

Authors

Lara A Ray
Steven J Nieto
Karen Miotto
Larissa Mooney
Richard LeBeau
Jin H Yoon
Joy M Schmitz
Ron Acierno
Nathaniel W Bailey
Jessica Jenkins
Jessica Vincent
Tracy Nolen
Shawn Hirsch
Alexis Williams
Scott D Lane

Language

English

Publication Date

2-3-2026

Journal

Trials

DOI

10.1186/s13063-026-09489-7

PMID

41630040

PMCID

PMC12958697

PubMedCentral® Posted Date

2-3-2026

PubMedCentral® Full Text Version

Author MSS

Abstract

Background: Alcohol use disorder (AUD) represents a highly prevalent, costly, and often untreated condition in the United States. Post-traumatic stress disorder (PTSD) represents a common comorbidity with AUD which worsens outcomes and decreases functional outcomes. Suvorexant (SUV) shows clear promise as a novel therapeutic candidate to treat AUD and PTSD.

Methods: This study features a promising compound (i.e., suvorexant), the application of a well-established human laboratory paradigm (i.e., alcohol cue reactivity), and a novel early efficacy laboratory model (i.e., practice quit attempt) to provide a cost/time-efficient evaluation of safety and initial efficacy of suvorexant for AUD with comorbid PTSD. Additionally, by collecting both objective and subjective sleep measures, the study provides an assessment of a putative mechanism through which suvorexant jointly addresses an intervening variable common to both AUD and PTSD.

Discussion: The combination of human laboratory modeling and real-world clinical outcomes provides a unique and synergistic set of data that can advance the development of suvorexant and identify its behavioral mechanisms of action. The recruitment of individuals with AUD and PTSD with sleep disturbances and who are intrinsically motivated to quit is a novel approach to screening pharmacotherapies by bridging the gap between experimental studies with non-treatment seekers and clinical trials with treatment-seeking individuals.

Keywords

Humans, Stress Disorders, Post-Traumatic, Triazoles, Alcoholism, Azepines, Randomized Controlled Trials as Topic, Treatment Outcome, Clinical Trials, Phase II as Topic, Orexin Receptor Antagonists, Sleep, Alcohol use disorder, Insomnia, Medication development, Post-traumatic stress disorder, Suvorexant

Comments

Trial registration: ClinicalTrials.gov NCT06679062 "Suvorexant for Treatment of AUD and PTSD (SUV)." Registered on November 12, 2024.

Published Open-Access

yes

Recommended Citation

Ray, Lara A; Nieto, Steven J; Miotto, Karen; et al., "Suvorexant for Alcohol Use Disorder and Post-traumatic Stress Disorder: Study Protocol for a Phase II Randomized Clinical Trial" (2026). Faculty, Staff and Student Publications. 6051.
https://digitalcommons.library.tmc.edu/uthgsbs_docs/6051