RECRUITING

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

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Conditions

Sleep Initiation and Maintenance DisordersStress Disorders, PosttraumaticSuvorexantVeterans

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2019-08-30
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03642028

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Men and Women, age range of 18 to 75, with a history of US military service, capable of reading and understanding English, and able to provide written informed consent
  2. * Criterion A event meets DSM-5 criteria
  3. * PTSD symptoms \>3 months duration as indexed by a CAPS-5 12 and a partial PTSD diagnosis at screening
  4. * Insomnia indicated by an ISI score \> 14
  5. * Subjects on non-exclusionary medications must be on a stable dose for at least 4 weeks prior to randomization, which includes the Selective Serotonin Reuptake Inhibitors (SSRIs) e.g.:
  6. * Sertraline
  7. * Paroxetine
  8. * Fluoxetine
  9. * Fluvoxamine
  10. * Citalopram
  11. * Escitalopram
  12. * Serotonin-norepinephrine reuptake inhibitors (SNRIs), e.g.:
  13. * Desvenlafaxine
  14. * Duloxetine
  15. * Levomilnacipran
  16. * Venlafaxine
  17. * For subjects who are in psychotherapy, treatment must be stable for 6 weeks
  18. * Women of child-bearing potential must not be pregnant or have plans for pregnancy or breastfeeding during the study and must use a medically acceptable method of birth control, e.g.:
  19. * oral
  20. * implantable
  21. * injectable
  22. * transdermal contraceptive
  23. * intrauterine device
  24. * double-barrier method
  25. * Sleep apnea score \<30; if screening indicates mild or moderate sleep apnea (score between 5 and 30), referral will be provided
  1. * DSM-5 alcohol, marijuana, and/or other drug use disorder in the last 3 months
  2. * Mild alcohol use not meeting criteria for moderate or severe use disorder may be allowed on a case-by-case basis
  3. * Mild or moderate marijuana use disorder may be allowed on a on a case-by-case basis
  4. * Manic or psychotic episode in the last 5 years
  5. * Exposure to trauma in the last 3 months
  6. * Prominent suicidal or homicidal ideation or any suicidal behavior in the past 3 months on the Columbia Suicide Severity Rating Scale (C-SSRS) or increased risk of suicide that necessitates additional therapy or inpatient treatment
  7. * Pre-existing severe sleep apnea (score \>30) in the absence of adherence to effective treatment (such as CPAP or oral device) or positive screen for severe sleep apnea by type III device (score \> 30)
  8. * Neurologic disorder or systemic illness affecting CNS function
  9. * Chronic or unstable medical illness including:
  10. * unstable angina
  11. * myocardial infarction within the past 6 months
  12. * congestive heart failure
  13. * preexisting hypotension or orthostatic hypotension
  14. * heart block or arrhythmia
  15. * chronic renal or hepatic failure
  16. * pancreatitis
  17. * severe chronic obstructive pulmonary disease
  18. * History of severe traumatic brain injury
  19. * Mild cognitive impairment assessed by the Montreal Cognitive Assessment
  20. * Pregnancy, breastfeeding and/or refusal to use effective birth control (for women)
  21. * Narcolepsy
  22. * Previous adverse reaction to a hypnotic
  23. * Current use of benzodiazepines, strong CYP3A inhibitors, or Digoxin
  24. * benzodiazepines
  25. * strong CYP3A inhibitors
  26. * Digoxin
  27. * Furthermore, CNS depressants (e.g., benzodiazepines, opioids, alcohol) increase the risk of CNS depression when co-administered with suvorexant and will not be allowed for safety reasons.
  28. * Since metabolism by CYP3A is the major elimination pathway for suvorexant, concomitant use of suvorexant with strong inhibitors of CYP3A (e.g., ketoconazole, itraconazole, posaconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, boceprevir, telaprevir, telithromycin and conivaptan), moderate CYP3A inhibitors (e.g., amprenavir, aprepitant, atazanavir, ciprofloxacin, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, imatinib, verapamil), or strong CYP3A inducers (e.g., rifampin, carbamazepine and phenytoin) will not be allowed.
  29. * All concomitant medication use will be monitored and documented

Contacts and Locations

Study Contact

Sabra S Inslicht, PhD
CONTACT
(415) 221-4810
sabra.inslicht@va.gov

Principal Investigator

Sabra S Inslicht, PhD
PRINCIPAL_INVESTIGATOR
San Francisco VA Medical Center, San Francisco, CA

Study Locations (Sites)

VA Long Beach Healthcare System, Long Beach, CA
Long Beach, California, 90822
United States
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, 94121-1563
United States
Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC
Salisbury, North Carolina, 28144
United States
Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, 29401-5703
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Sabra S Inslicht, PhD, PRINCIPAL_INVESTIGATOR, San Francisco VA Medical Center, San Francisco, CA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-08-30
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2019-08-30
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • Sleep Initiation and Maintenance Disorders
  • Stress Disorders, Posttraumatic
  • Suvorexant
  • Veterans

Additional Relevant MeSH Terms

  • Sleep Initiation and Maintenance Disorders
  • Stress Disorders, Posttraumatic