Suvorexant for alcohol use disorder and post-traumatic stress disorder: study protocol for a phase II randomized clinical trial

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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. Trial registration: ClinicalTrials.gov NCT06679062 “Suvorexant for Treatment of AUD and PTSD (SUV).” Registered on November 12, 2024.
Funding Information
  • Congressionally Directed Medical Research Programs (W81XWH-22-2-0081)

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