Suvorexant for Post-Traumatic Stress Disorder

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen bySabra S Inslicht, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: VA Office of Research and Development

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for Veterans with PTSD and insomnia, focusing on those who experience symptoms like re-experiencing trauma, avoidance, negative thoughts or feelings, and hyperarousal. The study seeks participants who have not found relief through standard treatments.

Inclusion Criteria

Capable of reading and understanding English

Insomnia indicated by insomnia severity index (ISI) score > 14

Able to provide written informed consent

+6 more

Exclusion Criteria

Pre-existing moderate sleep apnea or positive screen for sleep apnea by type III device (AHI>15) in the absence of adherence to effective treatment (such as CPAP or oral device)

Exposure to trauma in the last 3 months

I have a brain condition or illness affecting my nervous system.

+13 more

Participant Groups

The study tests if Suvorexant (a medication that blocks a brain chemical promoting wakefulness) can help reduce PTSD symptoms by enhancing fear extinction—a process where repeated exposure to feared cues without danger lessens physiological reactions.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: SuvorexantExperimental Treatment1 Intervention

Suvorexant pills (10-20 mg)

Group II: PlaceboPlacebo Group1 Intervention

Matching placebo pills