RecruitingPhase 4interventionalRules rewrite

Phase 4: testing Suvorexant for Insomnia

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.

Official registry: https://clinicaltrials.gov/study/NCT06788522 · VA Office of Research and Development · enrollment listed as 40,120

What this phase means

Phase 4: the treatment is already approved. This study asks new questions — longer-term effects, other diseases, or how it compares in everyday care.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Suvorexant, or Placebo. The registry lists allocation as randomized. PTSD affects approximately 22% of Veterans who have served in Iraq and Afghanistan.

They plan to enroll about 40,120 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

The Effects of Orexin Antagonism on Fear Extinction in PTSD

Interventions: Suvorexant, Placebo

Primary outcome (registry wording): Enrollment

Who it is for (from inclusion criteria)

Ages 18 Years to 75 Years
(same for Phase 1 and Phase 2):
a history of US military service
capable of reading and understanding English
Criterion A event meets DSM-5 criteria and occurred during military service, including combat and military sexual trauma
Chronic full PTSD diagnosis \>3 months duration as indexed by CAPS-5 at screening, and CAPS-5 score \> 30
Insomnia indicated by insomnia severity index (ISI) score \> 14
Subjects on non-exclusionary medications, and must be on a stable dose for at least 4 weeks prior to randomization, including Selective Serotonin Reuptake Inhibitors (SSRIs, e.g.,):

Who the registry excludes

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
Lifetime bipolar disorder I or II, schizophrenia, schizoaffective disorder, obsessive-compulsive disorder, or major depressive disorder with psychotic features
Exposure to trauma in the last 3 months
Use of exclusionary antidepressant (trazodone, mirtazapine, doxepin, tricyclics), mood stabilizers (e.g., lithium), antipsychotic medication

Public study contact (from the registry)

Sabra S Inslicht, PhD

(415) 221-4810

sabra.inslicht@va.gov

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

2 listed

San Francisco VA Medical Center, San Francisco, CA — San Francisco, California (recruiting)
Ralph H. Johnson VA Medical Center, Charleston, SC — Charleston, South Carolina (not_yet_recruiting)

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FAQ about this NCT record

Is NCT06788522 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06788522?

Phase 4. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06788522?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary