Suvorexant: A Dual Orexin Receptor Antagonist for Treating Sleep Disturbance in Posttraumatic Stress

Part of paid clinical trials in Long Beach, California.

Sponsor
VA Office of Research and Development
Study ID
NCT03642028
Phase
PHASE4
Status
Recruiting
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Conditions

  • Sleep Initiation and Maintenance Disorders
  • Stress Disorders, Posttraumatic

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Suvorexant — DRUG
    Suvorexant, a dual orexin receptor antagonist, is the first in a new class of drugs with great promise of addressing insomnia in Veterans with PTSD. Suvorexant targets the orexin neuropeptide system and has been shown to be highly successful in treating insomnia.
  • Placebo — OTHER
    Visibly matched, equally weighted placebo tablets. In addition to matching in appearance and weight, they will have identical packaging and labeling as randomized, blinded study medication.

Study Details

Post-traumatic stress disorder (PTSD) is a common consequence of combat that can result in trauma-related hyperarousal and sleep disturbances. Poor sleep, one of the most common complaints in Veterans with PTSD, can be distressing, impair concentration and memory, and contribute to physical health conditions, such as metabolic syndrome, inflammation, and cardiovascular disease. The orexin neuropeptide system underlies both sleep and stress reactivity. Suvorexant, a drug that reduces orexin, improves sleep in civilians, but has not yet been tested in Veterans with PTSD. This study will test whether suvorexant can improve sleep disturbances and PTSD symptoms in Veterans. Suvorexant may benefit Veterans by improving sleep quickly while also reducing PTSD symptoms over the long term, and with fewer side effects that were common in previous medications used to treat these conditions. Improving Veterans' sleep and PTSD symptoms could lead to better emotional and physical well-being, quality of life, relationships, and functioning.

Key Dates

Start date
Aug 30, 2019
Status verified
Jul 2025
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
190 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Suvorexant
    Suvorexant is a dual orexin receptor antagonist that is FDA approved to treat insomnia.
  • Placebo Comparator: Identical Placebo
    Visibly matched, equally weighted placebo tablets. In addition to matching in appearance and weight, they will have identical packaging and labeling as randomized, blinded study medication.

Primary Outcome Measure

Insomnia Severity Index (ISI) [ Time Frame: Change from baseline to week 12 ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
VA Long Beach Healthcare System, Long Beach, CALong BeachCalifornia90822
Michael Hollifield, MD
[email protected]
562-967-0115
San Francisco VA Medical Center, San Francisco, CASan FranciscoCalifornia94121-1563
Sabra S Inslicht, PhD
[email protected]
415-221-4810
Sabra S Inslicht, PhD (PRINCIPAL_INVESTIGATOR)
Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NCSalisburyNorth Carolina28144
Robin Hurley, MD
[email protected]
704-638-9000
Amy Morris
[email protected]
7046389000
Ralph H. Johnson VA Medical Center, Charleston, SCCharlestonSouth Carolina29401-5703
Zhewu Wang, MD
[email protected]
843-252-3586
Lisa McTeague, PhD
[email protected]
8435775011

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By research site
VA Long Beach Healthcare System, Long Beach, CA· Long Beach, CASan Francisco VA Medical Center, San Francisco, CA· San Francisco, CASalisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC· Salisbury, NCRalph H. Johnson VA Medical Center, Charleston, SC· Charleston, SC

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