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Suvorexant + Therapy for PTSD and Insomnia

SS
BS
Overseen ByBella S Benzaken, MA
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Northern California Institute of Research and Education
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for Veterans and military personnel who have PTSD and trouble sleeping, with or without mild-to-moderate traumatic brain injury. Participants should be able to attend weekly therapy sessions and take medication nightly for 8 weeks.

Inclusion Criteria

Women of childbearing potential: negative urine pregnancy test at screening; agree to use a medically acceptable contraception method during treatment
I have been in stable supportive therapy for at least 6 weeks, without PTSD or CBT-I therapy.
I have had PTSD for more than 3 months and my symptoms are significant.
See 4 more

Exclusion Criteria

Previous adverse reaction to a hypnotic
Night shift work or extreme morning or evening tendencies
Severe cognitive impairment as assessed by the MoCA or alternative validated threshold per site SOP
See 10 more

What Are the Treatments Tested in This Trial?

Interventions

  • Prolonged Exposure Therapy for Primary Care (PE-PC)
  • Suvorexant

Trial Overview

The study compares two groups: one receives a sleep medicine called suvorexant plus brief exposure therapy (PE-PC), while the other gets placebo pills plus the same therapy. The goal is to see if adding suvorexant helps more with PTSD symptoms, sleep, and daily functioning.

How Is the Trial Designed?

2

Treatment groups

Active Control

Placebo Group

Group I: PE-PC + SuvorexantActive Control2 Interventions
Group II: PE-PC + PlaceboPlacebo Group2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northern California Institute of Research and Education

Lead Sponsor

Trials
30
Recruited
10,400+

Lowcountry Center for Veterans Research

Collaborator

Trials
1
Recruited
300+

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