Suvorexant 3 - PE-PC

Conditions

• Insomnia
• PTSD - Post Traumatic Stress Disorder
• TBI (Traumatic Brain Injury)

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Suvorexant — DRUG
  Suvorexant (10-20 mg) taken orally once nightly for 8 weeks, combined with weekly Prolonged Exposure for Primary Care (PE-PC) therapy sessions. Suvorexant is an FDA-approved orexin receptor antagonist indicated for the treatment of insomnia.
• Placebo — DRUG
  A placebo pill taken orally once nightly for 8 weeks, combined with weekly Prolonged Exposure for Primary Care (PE-PC) therapy sessions. The placebo is a look-alike substance that contains no active drug and is used as a comparator to evaluate the efficacy of suvorexant.
• Prolonged Exposure Therapy for Primary Care (PE-PC) — BEHAVIORAL
  Prolonged Exposure for Primary Care (PE-PC) is a briefer version of traditional Prolonged Exposure (PE) therapy, delivered in weekly sessions over 8 weeks. PE-PC is designed to treat PTSD symptoms and related conditions such as insomnia and depression. All study participants will receive PE-PC therapy regardless of their assigned intervention arm (suvorexant or placebo).

Study Details

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.

Key Dates

Start date

Sep 1, 2026

Status verified

Jun 2026

Primary completion

Mar 1, 2029

Completion

Aug 30, 2029

Study Design

Enrollment

142 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: PE-PC + Suvorexant
  PE-PC with suvorexant
• Placebo Comparator: PE-PC + Placebo
  PE-PC with placebo

Primary Outcome Measure

Change from Baseline in PTSD Symptom Severity as Assessed by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) at Week 4, Week 8, and 6 Months [ Time Frame: Baseline (Week 0), Week 4 (Mid-Treatment), Week 8 (End of Treatment), and 6 months post-treatment; up to 32 weeks. ]

Central Contacts

• Sabra S Inslicht, PhD
  415-221-4810
  [email protected]
• Bella S Benzaken, MA
  415-221-4810
  [email protected]

Locations (1)

Find similar trials in San Francisco, CA

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