Clinical Trial

Suvorexant 3 - PE-PC

Not Yet Recruiting Phase 4
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Summary
The goal of this clinical trial is to learn if combining suvorexant (a sleep medication) with a shorter form of prolonged exposure therapy called PE-PC works to treat PTSD symptoms and improve sleep in Veterans and military personnel with PTSD and insomnia, with and without mild-to-moderate traumatic brain injury (TBI). The main questions it aims to answer are: Does suvorexant, when combined with PE-PC therapy, reduce PTSD symptoms more than PE-PC with a placebo (a look-alike substance that contains no drug)? Does suvorexant, when combined with PE-PC therapy, improve psychosocial and physical functioning more than PE-PC with a placebo? Researchers will compare PE-PC combined with suvorexant to PE-PC combined with a placebo to see if adding suvorexant improves PTSD symptoms, sleep, and overall functioning in Veterans. Participants will: Receive weekly PE-PC therapy sessions for 8 weeks Take suvorexant (10-20 mg) or a placebo each night during the 8-week treatment period. Complete repeated assessments of PTSD symptoms, sleep, and psychosocial and physical functioning throughout the study.
Trial Details
NCT Number NCT07686731
Lead Sponsor Northern California Institute of Research and Education
Collaborators: Lowcountry Center for Veterans Research
Conditions PTSD - Post Traumatic Stress Disorder, Insomnia, TBI (Traumatic Brain Injury)
Enrollment 142 participants
Start Date 2026-09-01
Primary Completion 2029-03-01 (estimated)
Study Completion 2029-08-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-07