PTSD - Post Traumatic Stress DisorderPhase 4NCT07686731
Suvorexant 3 - PE-PC
A Phase 4 study testing Suvorexant and Prolonged Exposure Therapy for Primary Care (PE-PC) in people with PTSD - Post Traumatic Stress Disorder and Insomnia, run by Northern California Institute of Research and Education at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- PTSD - Post Traumatic Stress Disorder, Insomnia, TBI (Traumatic Brain Injury)
- What is being tested?
- Suvorexant and Prolonged Exposure Therapy for Primary Care (PE-PC)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 142 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 30 Aug 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 18-75 years who are U.S. military Veterans; able to read/understand English and provide written informed consent;
- Exposure to a DSM-5 Criterion A traumatic event;
- Current PTSD, duration > 3 months, CAPS-5 total score ≥ 12
- Insomnia diagnosis indicated by ISI score >14
- 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.
- If in supportive psychotherapy, stable ≥ 6 weeks before randomization (no concurrent exposure-based PTSD or CBT-I).
- Women of childbearing potential: negative urine pregnancy test at screening; agree to use a medically acceptable contraception method during treatment.
Who cannot join
- 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;
- Lifetime bipolar disorder I or II, schizophrenia, schizoaffective disorder, obsessive-compulsive disorder, or major depressive disorder with psychotic features;
- Exposure to trauma in the last 3 months;
- 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;
- 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);
- Night shift work or extreme morning or evening tendencies;
Show all 13Show fewer
- Neurologic disorder or systemic illness affecting CNS function;
- 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);
- Severe cognitive impairment as assessed by the MoCA (or alternative validated threshold per site SOP)
- Pregnancy or breastfeeding, or unwillingness to use effective contraception (women of childbearing potential).
- Previous adverse reaction to a hypnotic;
- Current use of sedative-hypnotics, benzodiazepines, moderate or strong CYP3A inhibitors, or strong CYP3A inducers or Digoxin;
- Current participation in exposure-based PTSD or behavioral insomnia treatments.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
San Francisco VA Health Care System
San Francisco, California, 94121-1545
Sabra Inslicht, PhD, 415-221-4810 ext. 3341, Sabra.Inslicht@va.gov
About this study
Official title: Suvorexant: Targeting Orexin to Augment Exposure Therapy in Veterans With PTSD and Insomnia
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?
Read more
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.
Read the detailed description
Insomnia is the most prevalent symptom endorsed by PTSD patients and is highly prevalent in TBI, resulting in impairments in many domains of overall health and functioning. Prolonged exposure for primary care (PE-PC) is a shorter version of traditional PE that has demonstrated efficacy in the treatment of PTSD, related conditions (e.g., insomnia, depression), and improving functioning when compared to treatment as usual (e.g., PE, cognitive behavioral therapy for insomnia) in Veterans. However, challenges for PTSD interventions remain as some symptoms, particularly arousal and sleep-related difficulties, often fail to remit, with only 40-60% of Veterans showing clinically significant improvements following treatment, in addition to high attrition rates from these interventions. An integrated treatment that incorporates a pharmacological intervention that improves sleep during PE-PC may provide the greatest opportunity to facilitate recovery, by both increasing Veterans' engagement in treatment and supporting the extinction learning and consolidation mechanisms that promote recovery.
Hypothesis/Objective(s): The investigators aim to test whether integrating PE-PC with suvorexant, FDA-approved for the treatment of insomnia, will 1) promote the efficacy of PE-PC in improving sleep and PTSD symptoms in Veterans and military personnel with insomnia and posttraumatic stress disorder (PTSD) with and without mild-to-moderate traumatic brain injury (TBI); and 2) improve psychosocial and physical functioning.
Specific Aims: 1) To examine whether suvorexant facilitates PE-PC, seen as a greater reduction of PTSD symptoms over the course of treatment. 2) To examine whether suvorexant facilitates greater improvement in psychosocial and physical functioning compared to placebo over the course of treatment.
Study Design: The investigators propose an 8-week randomized, double-blind, placebo-controlled Phase IV clinical trial to examine the efficacy of augmenting PE-PC with suvorexant (10-20 mg) for the treatment of PTSD symptoms and improvement of functioning in Veterans with PTSD, insomnia, with and without TBI. The study design (N = 142) will involve repeated measures with two intervention arms, both of which include a standard course of weekly PE-PC therapy: 1) PE-PC+suvorexant (n = 71) compared to 2) PE-PC+placebo (n = 71).
Clinical Impact: This work aligns with the FY24 TBIPHRP CTA Research Level 2, Focus Area to Treat by examining repurposed interventions to improve outcomes of psychological health conditions and/or TBI through treatment and rehabilitation. The proposed intervention could promote sustained functional recovery following insomnia, PTSD, and TBI, as well as increased treatment engagement, retention, and success in those Veterans who would have otherwise not responded to treatment.
Relevance to Military Health: PTSD affects one in four treatment-seeking U.S. Veterans returning from Iraq and Afghanistan and one in 10 VA healthcare users. Sleep disturbance was the most frequently reported symptom in Veterans with PTSD, with the prevalence of insomnia or nonrestorative sleep estimated between 60%-90% and up to 97.4% of combat Veterans with TBI. However, effective and readily available treatments for co-occurring PTSD, insomnia, and TBI are not readily available or successful outside of PTSD specialty clinics, leading to unmet healthcare needs and/or treatment dropout/non-response. The ultimate goal of this work is to improve treatment availability and options for Veterans and military personnel affected by PTSD and TBI. Increased effectiveness of PTSD treatment in Veterans has the potential to: 1) optimize performance; 2) preserve health across the full deployment life cycle; and 3) improve long-term physical, social, and occupational functioning.
- Being tested
- Suvorexant, Placebo, Prolonged Exposure Therapy for Primary Care (PE-PC)
- Keywords
- PTSD, Insomnia, Sleep, Veterans, TBI, Prolonged Exposure Therapy for Primary Care (PE-PC), Stress Disorders, Post-Traumatic, suvorexant, Sleep Initiation and Maintenance Disorders, Orexin Receptor Antagonists, Dual Orexin Receptor Antagonists (DORA)
- Medical subject headings
- Combat Disorders, Sleep Initiation and Maintenance Disorders, Brain Injuries, Traumatic, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SuvorexantDrug
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.
PlaceboDrug
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.
Prolonged Exposure Therapy for Primary Care (PE-PC)Behavioural
Also called 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).
| Study group | Role | What they receive |
|---|---|---|
| PE-PC + Suvorexant | Active comparator | PE-PC with suvorexant Receives: Drug: Suvorexant; Behavioral: Prolonged Exposure Therapy for Primary Care (PE-PC) |
| PE-PC + Placebo | Placebo comparator | PE-PC with placebo Receives: Drug: Placebo; Behavioral: Prolonged Exposure Therapy for Primary Care (PE-PC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in PTSD Symptom Severity as Assessed by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) at Week 4, Week 8, and 6 Months
The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a 30-item clinician-administered interview measuring the frequency and intensity of PTSD symptoms. Total scores range from 0 to 80, with higher scores indicating greater PTSD symptom severity.
Measured: Baseline (Week 0), Week 4 (Mid-Treatment), Week 8 (End of Treatment), and 6 months post-treatment; up to 32 weeks.
Change from Baseline in Overall Functioning as Assessed by the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) at Week 4, Week 8, and 6 Months
The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) is a 36-item self-administered measure assessing functional ability across six domains. Summary scores range from 0 to 100, with higher scores indicating greater disability.
Measured: Baseline (Week 0), Week 4 (Mid-Treatment), Week 8 (End of Treatment), and 6 months post-treatment; up to 32 weeks
Secondary outcomes (6)
Change from Baseline in Insomnia Severity as Assessed by the Insomnia Severity Index (ISI) at Week 4, Week 8, and 6 Months
The Insomnia Severity Index (ISI) is a 7-item self-report measure of insomnia severity. Total scores range from 0 to 28, with higher scores indicating greater insomnia severity.
Measured: Baseline (Week 0), Week 4 (Mid-Treatment), Week 8 (End of Treatment), and 6 months post-treatment; up to 32 weeks
Change from Baseline in Objective Sleep Efficiency as Assessed by Wrist Actigraphy at Week 2, Week 4, Week 8, and 6 Months
Objective sleep efficiency will be assessed via wrist actigraphy worn continuously throughout the study. Sleep efficiency is calculated as the percentage of time in bed spent asleep, ranging from 0% to 100%, with higher values indicating better sleep efficiency. Sleep efficiency, sleep maintenance, total sleep time, and wake after sleep onset will be examined as secondary measures of sleep.
Measured: Baseline (Week 0), Week 4 (Mid-Treatment), Week 8 (End of Treatment), and 6 months post-treatment; up to 32 weeks
Change from Baseline in Subjective Sleep Efficiency as Assessed by Daily Sleep Diary at Week 2, Week 4, Week 8, and 6 Months
Subjective sleep efficiency will be assessed via daily self-reported sleep diary. Sleep efficiency is calculated as the percentage of time in bed spent asleep, ranging from 0% to 100%, with higher values indicating better sleep efficiency.
Measured: Baseline (Week 0), Week 4 (Mid-Treatment), Week 8 (End of Treatment), and 6 months post-treatment; up to 32 weeks
Change from Baseline in Psychosocial Functioning as Assessed by the Brief Inventory of Psychosocial Functioning (B-IPF) at Week 4, Week 8, and 6 Months
The B-IPF (Brief Inventory of Psychosocial Functioning) is a 7-item self-report measure assessing PTSD-related functional impairment in the past 30 days across seven functional domains, including romantic relationships, family relationships, work, friendships and socializing, parenting, education, and self-care.
Measured: Baseline (Week 0), Week 4 (Mid-Treatment), Week 8 (End of Treatment), and 6 months post-treatment; up to 32 weeks
Change from Baseline in Quality of Life as Assessed by the World Health Organization Quality of Life Assessment Brief Version (WHOQOL-BREF) at Week 4, Week 8, and 6 Months
The World Health Organization Quality of Life Assessment Brief Version (WHOQOL-BREF) is a 26-item instrument assessing quality of life across four domains: physical health, psychological health, social relationships, and environmental health. Items are scored 1-5 and transformed to a standardized scale of 0-100, with higher scores indicating better quality of life.
Measured: Baseline (Week 0), Week 4 (Mid-Treatment), Week 8 (End of Treatment), and 6 months post-treatment; up to 32 weeks
Change from Baseline in Engagement in Meaningful Activities as Assessed by the Engagement in Meaningful Activities Survey (EMAS) at Week 4, Week 8, and 6 Months
The Engagement in Meaningful Activities Survey (EMAS) is a 12-item scale assessing meaningful activity participation. Total scores range from 12 to 48, with higher scores indicating greater engagement in meaningful activities.
Measured: Baseline (Week 0), Week 4 (Mid-Treatment), Week 8 (End of Treatment), and 6 months post-treatment; up to 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Mar 2029 (estimated)
- Study completion30 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for PTSD - Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northern California Institute of Research and Education
- Sponsor type
- University, hospital or other
- Collaborators
- Lowcountry Center for Veterans Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07686731
- Sponsor's protocol ID
- 1874261
- Other IDs
- HT94252510779
- Status last verified
- Jun 2026
- First submitted
- 1 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie the results reported in publications will be shared, including data on primary and secondary outcome measures (PTSD symptom severity, psychosocial and physical functioning, sleep outcomes, and quality of life). Data will be de-identified prior to sharing to protect participant confidentiality. Demographic and clinical characteristics used to describe the study sample will also be made available.
Publications
Herring WJ, Connor KM, Ivgy-May N, Snyder E, Liu K, Snavely DB, Krystal AD, Walsh JK, Benca RM, Rosenberg R, Sangal RB, Budd K, Hutzelmann J, Leibensperger H, Froman S, Lines C, Roth T, Michelson D. Suvorexant in Patients With Insomnia: Results From Two 3-Month Randomized Controlled Clinical Trials. Biol Psychiatry. 2016 Jan 15;79(2):136-48. doi: 10.1016/j.biopsych.2014.10.003. Epub 2014 Oct 23.
PubMed 25526970Kobayashi I, Mellman TA, Cannon A, Brown I, Boadi L, Howell MK, Lavela P, Sandhu I. Blocking the orexin system following therapeutic exposure promoted between session habituation, but not PTSD symptom reduction. J Psychiatr Res. 2022 Jan;145:222-229. doi: 10.1016/j.jpsychires.2021.12.027. Epub 2021 Dec 14.
PubMed 34933185Rauch SAM, Kim HM, Acierno R, Ragin C, Wangelin B, Blitch K, Muzzy W, Hart S, Zivin K. Improving function through primary care treatment of posttraumatic stress disorder study outcomes: A randomized controlled trial of prolonged exposure for primary care in veterans. Fam Syst Health. 2023 Dec;41(4):502-513. doi: 10.1037/fsh0000823. Epub 2023 Aug 31.
PubMed 37650808Gilbert KS, Kark SM, Gehrman P, Bogdanova Y. Sleep disturbances, TBI and PTSD: Implications for treatment and recovery. Clin Psychol Rev. 2015 Aug;40:195-212. doi: 10.1016/j.cpr.2015.05.008. Epub 2015 Jun 3.
PubMed 26164549Wisco BE, Nomamiukor FO, Marx BP, Krystal JH, Southwick SM, Pietrzak RH. Posttraumatic Stress Disorder in US Military Veterans: Results From the 2019-2020 National Health and Resilience in Veterans Study. J Clin Psychiatry. 2022 Feb 22;83(2):20m14029. doi: 10.4088/JCP.20m14029.
PubMed 35192748Neylan TC, Marmar CR, Metzler TJ, Weiss DS, Zatzick DF, Delucchi KL, Wu RM, Schoenfeld FB. Sleep disturbances in the Vietnam generation: findings from a nationally representative sample of male Vietnam veterans. Am J Psychiatry. 1998 Jul;155(7):929-33. doi: 10.1176/ajp.155.7.929.
PubMed 9659859
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suvorexant: Targeting Orexin to Augment Exposure Therapy in Veterans With PTSD and Insomnia
- ClinicalTrials.gov ID
- NCT07686731
- Acronym / sponsor ID
- 1874261
- Keywords
- PTSD, Insomnia, Sleep, Veterans, TBI, Prolonged Exposure Therapy for Primary Care (PE-PC), Stress Disorders, Post-Traumatic, suvorexant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Northern California Institute of Research and EducationUniversity, hospital or other
- Collaborators
- Lowcountry Center for Veterans Research
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Mar 2029 (estimated)
- Study completion
- 30 Aug 2029 (estimated)
- First posted
- 7 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Insomnia is the most prevalent symptom endorsed by PTSD patients and is highly prevalent in TBI, resulting in impairments in many domains of overall health and functioning. Prolonged exposure for primary care (PE-PC) is a shorter version of traditional PE that has demonstrated efficacy in the treatment of PTSD, related conditions (e.g., insomnia, depression), and improving functioning when compared to treatment as usual (e.g., PE, cognitive behavioral therapy for insomnia) in Veterans. However, challenges for PTSD interventions remain as some symptoms, particularly arousal and sleep-related difficulties, often fail to remit, with only 40-60% of Veterans showing clinically significant improvements following treatment, in addition to high attrition rates from these interventions. An integrated treatment that incorporates a pharmacological intervention that improves sleep during PE-PC may provide the greatest opportunity to facilitate recovery, by both increasing Veterans' engagement in treatment and supporting the extinction learning and consolidation mechanisms that promote recovery.
Hypothesis/Objective(s): The investigators aim to test whether integrating PE-PC with suvorexant, FDA-approved for the treatment of insomnia, will 1) promote the efficacy of PE-PC in improving sleep and PTSD symptoms in Veterans and military personnel with insomnia and posttraumatic stress disorder (PTSD) with and without mild-to-moderate traumatic brain injury (TBI); and 2) improve psychosocial and physical functioning.
Specific Aims: 1) To examine whether suvorexant facilitates PE-PC, seen as a greater reduction of PTSD symptoms over the course of treatment. 2) To examine whether suvorexant facilitates greater improvement in psychosocial and physical functioning compared to placebo over the course of treatment.
Study Design: The investigators propose an 8-week randomized, double-blind, placebo-controlled Phase IV clinical trial to examine the efficacy of augmenting PE-PC with suvorexant (10-20 mg) for the treatment of PTSD symptoms and improvement of functioning in Veterans with PTSD, insomnia, with and without TBI. The study design (N = 142) will involve repeated measures with two intervention arms, both of which include a standard course of weekly PE-PC therapy: 1) PE-PC+suvorexant (n = 71) compared to 2) PE-PC+placebo (n = 71).
Clinical Impact: This work aligns with the FY24 TBIPHRP CTA Research Level 2, Focus Area to Treat by examining repurposed interventions to improve outcomes of psychological health conditions and/or TBI through treatment and rehabilitation. The proposed intervention could promote sustained functional recovery following insomnia, PTSD, and TBI, as well as increased treatment engagement, retention, and success in those Veterans who would have otherwise not responded to treatment.
Relevance to Military Health: PTSD affects one in four treatment-seeking U.S. Veterans returning from Iraq and Afghanistan and one in 10 VA healthcare users. Sleep disturbance was the most frequently reported symptom in Veterans with PTSD, with the prevalence of insomnia or nonrestorative sleep estimated between 60%-90% and up to 97.4% of combat Veterans with TBI. However, effective and readily available treatments for co-occurring PTSD, insomnia, and TBI are not readily available or successful outside of PTSD specialty clinics, leading to unmet healthcare needs and/or treatment dropout/non-response. The ultimate goal of this work is to improve treatment availability and options for Veterans and military personnel affected by PTSD and TBI. Increased effectiveness of PTSD treatment in Veterans has the potential to: 1) optimize performance; 2) preserve health across the full deployment life cycle; and 3) improve long-term physical, social, and occupational functioning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PE-PC + Suvorexant | Active comparator | Drug: Suvorexant, Behavioral: Prolonged Exposure Therapy for Primary Care (PE-PC)PE-PC with suvorexant |
| PE-PC + Placebo | Placebo comparator | Drug: Placebo, Behavioral: Prolonged Exposure Therapy for Primary Care (PE-PC)PE-PC with placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults 18-75 years who are U.S. military Veterans; able to read/understand English and provide written informed consent;
- Exposure to a DSM-5 Criterion A traumatic event;
- Current PTSD, duration > 3 months, CAPS-5 total score ≥ 12
- Insomnia diagnosis indicated by ISI score >14
- 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.
Key exclusion criteria (13 listed)
- 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;
- Lifetime bipolar disorder I or II, schizophrenia, schizoaffective disorder, obsessive-compulsive disorder, or major depressive disorder with psychotic features;
- Exposure to trauma in the last 3 months;
- 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;
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SuvorexantSuvorexant (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 | PE-PC + Suvorexant |
| PlaceboA 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. | Drug | PE-PC + Placebo |
| Prolonged Exposure Therapy for Primary Care (PE-PC)Also: PE-PCProlonged 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). | Behavioural | PE-PC + Placebo, PE-PC + Suvorexant |
Primary outcome
Change from Baseline in PTSD Symptom Severity as Assessed by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) at Week 4, Week 8, and 6 Months
Time frame: Baseline (Week 0), Week 4 (Mid-Treatment), Week 8 (End of Treatment), and 6 months post-treatment; up to 32 weeks.
The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a 30-item clinician-administered interview measuring the frequency and intensity of PTSD symptoms. Total scores range from 0 to 80, with higher scores indicating greater PTSD symptom severity.
Change from Baseline in Overall Functioning as Assessed by the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) at Week 4, Week 8, and 6 Months
Time frame: Baseline (Week 0), Week 4 (Mid-Treatment), Week 8 (End of Treatment), and 6 months post-treatment; up to 32 weeks
The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) is a 36-item self-administered measure assessing functional ability across six domains. Summary scores range from 0 to 100, with higher scores indicating greater disability.
6 secondary outcomes
Change from Baseline in Insomnia Severity as Assessed by the Insomnia Severity Index (ISI) at Week 4, Week 8, and 6 Months
Time frame: Baseline (Week 0), Week 4 (Mid-Treatment), Week 8 (End of Treatment), and 6 months post-treatment; up to 32 weeks
Change from Baseline in Objective Sleep Efficiency as Assessed by Wrist Actigraphy at Week 2, Week 4, Week 8, and 6 Months
Time frame: Baseline (Week 0), Week 4 (Mid-Treatment), Week 8 (End of Treatment), and 6 months post-treatment; up to 32 weeks
Change from Baseline in Subjective Sleep Efficiency as Assessed by Daily Sleep Diary at Week 2, Week 4, Week 8, and 6 Months
Time frame: Baseline (Week 0), Week 4 (Mid-Treatment), Week 8 (End of Treatment), and 6 months post-treatment; up to 32 weeks
Change from Baseline in Psychosocial Functioning as Assessed by the Brief Inventory of Psychosocial Functioning (B-IPF) at Week 4, Week 8, and 6 Months
Time frame: Baseline (Week 0), Week 4 (Mid-Treatment), Week 8 (End of Treatment), and 6 months post-treatment; up to 32 weeks
Change from Baseline in Quality of Life as Assessed by the World Health Organization Quality of Life Assessment Brief Version (WHOQOL-BREF) at Week 4, Week 8, and 6 Months
Time frame: Baseline (Week 0), Week 4 (Mid-Treatment), Week 8 (End of Treatment), and 6 months post-treatment; up to 32 weeks
Change from Baseline in Engagement in Meaningful Activities as Assessed by the Engagement in Meaningful Activities Survey (EMAS) at Week 4, Week 8, and 6 Months
Time frame: Baseline (Week 0), Week 4 (Mid-Treatment), Week 8 (End of Treatment), and 6 months post-treatment; up to 32 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Background: PubMed 25526970Herring WJ, Connor KM, Ivgy-May N, Snyder E, Liu K, Snavely DB, Krystal AD, Walsh JK, Benca RM, Rosenberg R, Sangal RB, Budd K, Hutzelmann J, Leibensperger H, Froman S, Lines C, Roth T, Michelson D. Suvorexant in Patients With Insomnia: Results From Two 3-Month Randomized Controlled Clinical Trials. Biol Psychiatry. 2016 Jan 15;79(2):136-48. doi: 10.1016/j.biopsych.2014.10.003. Epub 2014 Oct 23.
- Background: PubMed 34933185Kobayashi I, Mellman TA, Cannon A, Brown I, Boadi L, Howell MK, Lavela P, Sandhu I. Blocking the orexin system following therapeutic exposure promoted between session habituation, but not PTSD symptom reduction. J Psychiatr Res. 2022 Jan;145:222-229. doi: 10.1016/j.jpsychires.2021.12.027. Epub 2021 Dec 14.
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- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie the results reported in publications will be shared, including data on primary and secondary outcome measures (PTSD symptom severity, psychosocial and physical functioning, sleep outcomes, and quality of life). Data will be de-identified prior to sharing to protect participant confidentiality. Demographic and clinical characteristics used to describe the study sample will also be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Suvorexant and Prolonged Exposure Therapy for Primary Care (PE-PC) in people with PTSD - Post Traumatic Stress Disorder and Insomnia, run by Northern California Institute of Research and Education at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sabra S Inslicht, PhD (415-221-4810 ext. 2-3341, sabra.inslicht@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in PTSD Symptom Severity as Assessed by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) at Week 4, Week 8, and 6 Months (time frame: Baseline (Week 0), Week 4 (Mid-Treatment), Week 8 (End of Treatment), and 6 months post-treatment; up to 32 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07686731, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.