Suvorexant and Sleep's Benefits to Therapeutic Exposure for Posttraumatic Stress Disorder

• Status: Completed
• Trial end date: 2021-05-19
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to examine effects of blocking the orexin system with suvorexant after exposure-based intervention for posttraumatic stress disorder (PTSD) on sleep, PTSD symptoms, and intersession habituation.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Howard University
• Collaborators: Georgetown-Howard Universities Center for Clinical and Translational Science; National Institute of Mental Health (NIMH)
• Treatments: Suvorexant

Criteria

Inclusion Criteria:

• Adult men and women (age 18 or older) who meet the Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5) criteria for PTSD.

Exclusion Criteria:

• Medical or psychiatric conditions that require consistent use of medication that affects sleep or psychiatric symptoms, except for hormonal contraceptives

• Any persistent medical condition that affects sleep

• Inability to remember most details of the index event

• Diagnosis of a sleep disorder other than insomnia including polysomnography findings of apnea/hypopnea index > 10/hour

• Consumption of more caffeine than 5 cups of coffee/day equivalent

• Smoking > 20 cigarettes/day

• Habitual bedtimes after 3AM, habitual rise times after 10AM, or average napping > 2 hour/day in a given week

• Moderate or severe alcohol use disorder within the past 6 months or moderate or severe drug use disorder within the past year

• Positive urine toxicology for illicit drugs including cannabis

• A history of psychotic disorders or bipolar disorder

• Current depression with history of recurrent depression that precedes exposure to a traumatic event

• Suicidal ideation with intent to act or with specific plan and intent in the past 6 months [Type 4 - 5 ideation on the Columbia Suicide Severity Rating Scale (C-SSRS)] or history of a suicide attempt

• Completion of exposure-based therapy targeting the index trauma

• Pregnancy or breast feeding

• Known sensitivity or allergy to an orexin receptor antagonist

• Limited ability to read or write English.