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The Effects of Orexin Antagonism on Fear Extinction in PTSD

StatusNot Yet Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Start date: May 1, 2026 to Jun 1, 2026v6
  2. Start date: Mar 1, 2026 to May 1, 2026 Site contacts updated at 1 of 2 sitesv5 Show 1 more changeShow less
    • Site contacts updated at 1 of 2 sites
  3. Start date: Jan 1, 2026 to Mar 1, 2026 Site contacts updated at 1 of 2 sitesv4 Show 1 more changeShow less
    • Site contacts updated at 1 of 2 sites
  4. Start date: Oct 1, 2025 to Jan 1, 2026 Site contacts updated at 1 of 2 sitesv3 Show 1 more changeShow less
    • Site contacts updated at 1 of 2 sites
  5. Re-verified, no change to tracked fieldsv2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
PTSD affects approximately 22% of Veterans who have served in Iraq and Afghanistan. Symptoms of PTSD may include re-experiencing, avoidance of trauma reminders, negative thoughts or feelings, and hyperarousal, such as increased startle reactivity and disturbed sleep. Treatments for PTSD are based on fear extinction principles in which individuals are repeatedly exposed a feared cue in the absence of danger, resulting in diminishing physiological reactions, a process believed to underlie recovery from PTSD. Studies suggest that orexin, a wake-promoting neuropeptide, may enhance fear extinction. This study will examine whether suvorexant, a selective orexin-receptor antagonist, will enhance fear extinction in Veterans with PTSD and insomnia. Finding a role for orexins in fear extinction will support the rationale for its further evaluation in the treatment of PTSD. Suvorexant is an accessible, safe medication that has been well-established in treating insomnia. It has outstanding promise for treating common and distressing symptoms in Veterans with PTSD.
Trial Details
NCT Number NCT06788522
Lead Sponsor VA Office of Research and Development
Conditions Insomnia, PTSD
Enrollment 40,120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov