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NOT YET RECRUITING

NCT07686731

PHASE4

Suvorexant 3 - PE-PC

Sponsor: Northern California Institute of Research and Education

View on ClinicalTrials.gov

Summary

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.

Official title: Suvorexant: Targeting Orexin to Augment Exposure Therapy in Veterans With PTSD and Insomnia

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

142

Start Date

2026-09-01

Completion Date

2029-08-30

Last Updated

2026-07-07

Healthy Volunteers

Conditions

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

Interventions

DRUG

Suvorexant

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.

DRUG

Placebo

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.

BEHAVIORAL

Prolonged Exposure Therapy for Primary Care (PE-PC)

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).

Inclusion Criteria: 1. Adults 18-75 years who are U.S. military Veterans; able to read/understand English and provide written informed consent; 2. Exposure to a DSM-5 Criterion A traumatic event; 3. Current PTSD, duration \> 3 months, CAPS-5 total score ≥ 12 4. Insomnia diagnosis indicated by ISI score \>14 5. If taking non-exclusionary psychotropics (e.g., SSRI/SNRI, tetracyclic antidepressants, tricyclics, antipsychotics, and mood stabilizers, insomnia medication, neuroleptics, anti-psychotics) must be on a dose stable ≥ 4 weeks before randomization. 6. If in supportive psychotherapy, stable ≥ 6 weeks before randomization (no concurrent exposure-based PTSD or CBT-I). 7. Women of childbearing potential: negative urine pregnancy test at screening; agree to use a medically acceptable contraception method during treatment. Exclusion Criteria: 1. DSM-5 alcohol, marijuana, and/or other substance use disorder in the last 3 months. Mild alcohol and marijuana use not meeting criteria for disorder permissible; 2. Lifetime bipolar disorder I or II, schizophrenia, schizoaffective disorder, obsessive-compulsive disorder, or major depressive disorder with psychotic features; 3. Exposure to trauma in the last 3 months; 4. Prominent suicidal or homicidal ideation, any suicidal behavior in the past 3 months on the Columbia Suicide Severity Rating Scale (C-SSRS)83, or increased risk of suicide that necessitates additional therapy or inpatient treatment; 5. Pre-existing sleep apnea by type III device with AHI \>15 in the absence of adherence to effective treatment (such as CPAP or oral device); 6. Night shift work or extreme morning or evening tendencies; 7. Neurologic disorder or systemic illness affecting CNS function; 8. Chronic or unstable medical illness (i.e., angina, myocardial infarction within the past 6 months, congestive heart failure, preexisting hypotension or orthostatic hypotension, heart block or arrhythmia, chronic renal or hepatic failure, pancreatitis, and severe chronic obstructive pulmonary disease); 9. Severe cognitive impairment as assessed by the MoCA (or alternative validated threshold per site SOP) 10. Pregnancy or breastfeeding, or unwillingness to use effective contraception (women of childbearing potential). 11. Previous adverse reaction to a hypnotic; 12. Current use of sedative-hypnotics, benzodiazepines, moderate or strong CYP3A inhibitors, or strong CYP3A inducers or Digoxin; 13. Current participation in exposure-based PTSD or behavioral insomnia treatments.

Locations (1)

San Francisco VA Health Care System

San Francisco, California, United States