The Effects of Orexin Antagonism on Fear Extinction in PTSD

ConditionsInsomniaPTSD
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorVA Office of Research and Development

About 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

Qualifiers

men and women

a history of US military service

capable of reading and understanding English

able to provide written informed consent

Disqualifiers

Moderate or severe DSM-5 alcohol or cannabis use disorder in the last 3 months

Mild alcohol use disorder with abstinence of 30 days will be allowed

Mild marijuana use disorder will be allowed with abstinence for one week prior to participation

Any other DSM-5 drug use disorder in the last 3 months will be excluded

Trial design

Treatments tested in this trial

  • Suvorexant
  • Placebo

Treatment groups

40,120 Participants
are divided into 2 treatment groups

Locations

2
San Francisco VA Medical Center, San Francisco, CA94121-1563, San FranciscoCalifornia, United States
Ralph H. Johnson VA Medical Center, Charleston, SC29401-5703, CharlestonSouth Carolina, United States

Sponsors and collaborators

VA Office of Research and Development

Lead sponsor