The Effects of Orexin Antagonism on Fear Extinction in PTSD

Part of paid clinical trials in San Francisco, California.

Sponsor
VA Office of Research and Development
Study ID
NCT06788522
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Suvorexant — DRUG
    Suvorexant pills (10-20 mg)
  • Placebo — DRUG
    Matching placebo pills

Study Details

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.

Key Dates

Start date
Jun 1, 2026
Status verified
May 2026
Primary completion
Mar 1, 2032
Completion
Jun 30, 2032

Study Design

Enrollment
40,120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Suvorexant
    Suvorexant pills (10-20 mg)
  • Placebo Comparator: Placebo
    Matching placebo pills

Primary Outcome Measure

enrollment [ Time Frame: Month 4-23 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
San Francisco VA Medical Center, San Francisco, CASan FranciscoCalifornia94121-1563
Sabra S Inslicht, PhD
[email protected]
(415) 221-4810
Sabra S Inslicht, PhD (PRINCIPAL_INVESTIGATOR)
Ralph H. Johnson VA Medical Center, Charleston, SCCharlestonSouth Carolina29401-5703
Lisa McTeague, PhD
[email protected]

Find similar trials in San Francisco, CA

By condition
InsomniaPTSD (post-traumatic stress disorder)
By specialty
Mental healthSleep medicinePsychiatryBehavioral health
By research site
San Francisco VA Medical Center, San Francisco, CA· San Francisco, CARalph H. Johnson VA Medical Center, Charleston, SC· Charleston, SC

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