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NCT07686731 · ClinicalTrials.gov registry record · Phase 4
Suvorexant 3 - PE-PC
A Phase 4 study, sponsored by Northern California Institute of Research and Education.
- Not yet
- Registry status
- Phase 4
- Development phase
- 142
- Enrollment target
NCT07686731: Clinical Trial Phase 4 study, sponsored by Northern California Institute of Research and Education.
NCT07686731 is a Phase 4 study that has not yet begun recruiting, run by Northern California Institute of Research and Education. The registered enrollment target is 142 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07686731, a Phase 4 study, has not yet begun recruiting, sponsored by Northern California Institute of Research and Education.
- NOT YET RECRUITING
- Registry status
- Phase 4
- Development phase
- 142 participants
- Enrollment target
Study Summary
The goal of this clinical trial is to learn if combining suvorexant (a sleep medication) with a shorter form of prolonged exposure therapy called PE-PC works to treat PTSD symptoms and improve sleep in Veterans and military personnel with PTSD and insomnia, with and without mild-to-moderate traumatic brain injury (TBI). The main questions it aims to answer are: Does suvorexant, when combined with PE-PC therapy, reduce PTSD symptoms more than PE-PC with a placebo (a look-alike substance that contains no drug)? Does suvorexant, when combined with PE-PC therapy, improve psychosocial and physical functioning more than PE-PC with a placebo? Researchers will compare PE-PC combined with suvorexant to PE-PC combined with a placebo to see if adding suvorexant improves PTSD symptoms, sleep, and overall functioning in Veterans. Participants will: Receive weekly PE-PC therapy sessions for 8 weeks Take suvorexant (10-20 mg) or a placebo each night during the 8-week treatment period. Complete repeated assessments of PTSD symptoms, sleep, and psychosocial and physical functioning throughout the study.
Primary Outcome
The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a 30-item clinician-administered interview measuring the frequency and intensity of PTSD symptoms. Total scores range from 0 to 80, with higher scores indicating greater PTSD symptom severity.
Interventions
- DRUG Placebo
- DRUG Suvorexant
- BEHAVIORAL Prolonged Exposure Therapy for Primary Care (PE-PC)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 142 participants |
| Start Date | 2026-09-01 |
| Est. Completion | 2029-08-30 |
| Phase | Phase 4 |
What is known before NCT07686731 opens enrollment
NCT07686731 is an interventional study that assigns participants to a tested intervention. The registered 142 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT07686731 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07686731 about?
NCT07686731 is a clinical study titled "Suvorexant 3 - PE-PC". The goal of this clinical trial is to learn if combining suvorexant (a sleep medication) with a shorter form of prolonged exposure therapy called PE-PC works to treat PTSD symptoms and improve sleep in Veterans and military personnel with PTSD and insomnia, with and without mild-to-moderate traumati...
What is the current status of trial NCT07686731?
This trial is currently not yet recruiting. It is a Phase 4 study. The enrollment target is 142 participants. The study started on 2026-09-01. Estimated completion is 2029-08-30.
What interventions are being tested in trial NCT07686731?
The interventions under investigation include: Placebo (DRUG), Suvorexant (DRUG), Prolonged Exposure Therapy for Primary Care (PE-PC) (BEHAVIORAL).
Who is sponsoring clinical trial NCT07686731?
This trial is sponsored by Northern California Institute of Research and Education, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07686731's enrollment target sits among peer trials
142 580th of 2000 higher than 1,421 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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