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Can these pills help veterans with PTSD finally sleep?

NCT ID NCT03668041

Symptom relief Sponsor: VA Office of Research and Development Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested two sleep medications, trazodone and eszopiclone, in 673 veterans with PTSD-related insomnia. The goal was to see if these drugs could reduce insomnia symptoms over 12 weeks. Participants were adults aged 18-75 with military-related PTSD and insomnia. The study compared the drugs to a placebo to find a safe and effective sleep aid for this group.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

673 people

The number who actually took part.

Started

Feb 2021

Finished

Mar 2026

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Ability to comprehend and provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study (approximately 17 weeks from the date of being randomized) 3. Individuals, between the ages of 18 and 75 years 4. Allow digital recording of phone interviews 5. PTSD related to military service 6. Primary DSM-5 diagnosis of PTSD, assessed by structured interview using the CAPS-5 7. Total CAPS-5 score 23 8. ISI \>15 9. Screening clinical laboratory tests without clinically significant abnormalities that would make study participation inappropriate, as determined by the site investigator with input, if needed, from the study chair 10. Electrocardiogram (ECG) at baseline without clinically significant abnormalities that would make study participation inappropriate, as determined by the site investigator with input, if needed, from the study chair and/or contingent upon approval by consulting medical physician. 11. Females of childbearing potential: 1. Must have a negative pregnancy test during screening 2. Must agree not to become pregnant or breastfeed during the course of the study 3. Must be willing to use a reliable form of contraception for 16 weeks (during study treatment and for 2 weeks after taking the last dose) which includes: barrier contraceptives (male or female condoms with or without a spermicide, diaphragm or cervical cap with spermicide, or intrauterine device) and hormone-based therapy (contraceptive pills, intrauterine devices, or Depo-Provera®) 4. Birth control for female participants is not necessary if surgically sterile or if with a partner with whom they are not capable of conceiving children (defined as a surgically sterile female by hysterectomy, bilateral oophorectomy, or bilateral tubal ligation; surgically sterile male who has undergone a complete orchiectomy or successful vasectomy; or a same sex partner) 12. Agree to secure firearms while receiving study treatment 13. If individuals are undergoing evidence-based psychotherapy (EBT), which includes cognitive behavioral therapy (CBT), cognitive processing therapy (CPT), prolonged exposure therapy (PE), and/or stress inoculation therapy (SIT), they must have started these therapies at least 60 days prior to starting screening. If screening is started, and it is then discovered that EBT was started within 60 days prior to screening, participants must wait at least 60 days since staring the new EBT before they can complete the screening ISI, the screening PCL, and the Phone Assessment. (Supportive individual and group therapy is allowed) 14. Agreement to adhere to Lifestyle Considerations (see Section 5.3) throughout study participation 15. Clinical evidence of adequately treated sleep apnea or absence of sleep apnea having a severity that would make study participation problematic, established by meeting one of the criteria below: 1. Clinical evidence of adequately treated sleep apnea with a continuous positive airway pressure (CPAP) or alternative treatment device (as defined in Section 8.1) (Participants can be reevaluated at least 30 days after screen failure.) 2. If clinically tested, sleep study negative for sleep apnea or results indicating an Apnea-Hypopnea Index (AHI) \< 23 within the past 6 months 3. If tested for study eligibility, ApneaLink (or equivalent alternative device) result or other sleep study shows AHI \< 23. Exclusion Criteria: 1. Currently enrolled in any other interventional study unless prior approval is provided by the study team (It is a CSP policy that exemptions will be assessed for individual patients on a case-by-case basis. Exemptions require the agreement in writing of the following individuals or groups: (1) the SIs of both studies; (2) the Study Chairs of the involved studies; (3) the appropriate CSP Center Director(s); and (4) the VA Central IRB.) 2. Allergy and/or history of intolerance to trazodone hydrochloride and/or eszopiclone, or history of experiencing complex sleep behaviors (i.e., sleep walking, sleep driving, and/or engaging in other activities while not fully awake) while taking any sleep medication 3. A comorbid current or lifetime diagnosis of bipolar I disorder, bipolar II disorder, schizoaffective disorder, schizophrenia or delusional disorder, or current comorbid diagnosis of schizophreniform disorder, brief psychotic disorder, psychotic disorder due to a general medical condition, substance-induced psychotic disorder or psychotic disorder not otherwise specified (NOS) according to Structured Clinical Interview for DSM-5 (SCID)-I-RV/P 4. History of moderate or severe traumatic brain injury (TBI) or history of gross structural damage as shown on MRI. 5. Positive urine test for an illicit substance, excluding cannabis, within the past 90 days prior to screening 6. Substance use meeting DSM-5 criteria for moderate or severe dependence (excluding nicotine) within the past 12 months prior to screening. (Note: Current mild dependence for alcohol and cannabis use is acceptable, but current mild dependence of any other substances is exclusionary.) 7. Inpatient psychiatric hospitalization within 30 days prior to screening 8. Suicidal or homicidal ideation with intent or plan to harm themselves or others within 90 days prior to screening 9. Chronic liver disease with two or more of the following occurring within the past six months: international normalized ratio (INR) greater than or equal to 1.7 (not on warfarin therapy), bilirubin greater than or equal to 2 mg/dL, serum albumin less than or equal to 3.5 g/dL, ascites, or encephalopathy (Participants can be reevaluated in 30 days) 10. Clinical and laboratory evidence of untreated hypothyroidism or hyperthyroidism 11. A corrected QT (QTc) interval greater than 470 ms 12. Unstable, serious medical condition or one requiring acute medical treatment, or planned hospitalization for extended care 13. Dementia, epilepsy, stroke, or current treatment with warfarin for anticoagulation 14. Taking any of the exclusionary medications listed in Appendix A. Note- an individual taking one of these medications for the sole purpose of improving sleep that elects to undergo an adequate wash-out period of at least 5 half-lives of the parent compound or active metabolite (e.g., for medications like diazepam), under the care of the individual's clinical provider, would not be excluded by this criterion. 15. Under criminal investigation or pending legal charges with potential incarceration 16. Individuals who lack stable contact information (including lack of a telephone number) 17. Participants who anticipate working during the hours of midnight to 6am during the course of study trial 18. Participants with narcolepsy

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Conditions

The condition(s) this trial relates to.

insomnia post-traumatic stress disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Insomnia

Contacts and locations

Locations

  • Asheville VA Medical Center, Asheville, NC

    Asheville, North Carolina, 28805, United States

  • Atlanta VA Medical and Rehab Center, Decatur, GA

    Decatur, Georgia, 30033, United States

  • Bay Pines VA Healthcare System, Pay Pines, FL

    Bay Pines, Florida, 33744-0000, United States

  • Birmingham VA Medical Center, Birmingham, AL

    Birmingham, Alabama, 35233, United States

  • CERC (VISN1, West Haven, CT)

    West Haven, Connecticut, 06516, United States

  • Cincinnati VA Medical Center, Cincinnati, OH

    Cincinnati, Ohio, 45220-2213, United States

  • Clement J. Zablocki VA Medical Center, Milwaukee, WI

    Milwaukee, Wisconsin, 53295-0001, United States

  • Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

    Philadelphia, Pennsylvania, 19104, United States

  • Durham VA Medical Center, Durham, NC

    Durham, North Carolina, 27705-3875, United States

  • Edward Hines Jr. VA Hospital, Hines, IL

    Hines, Illinois, 60141-3030, United States

  • Louis Stokes VA Medical Center, Cleveland, OH

    Cleveland, Ohio, 44106, United States

  • Michael E. DeBakey VA Medical Center, Houston, TX

    Houston, Texas, 77030-4211, United States

  • Minneapolis VA Health Care System, Minneapolis, MN

    Minneapolis, Minnesota, 55417, United States

  • New Mexico VA Health Care System, Albuquerque, NM

    Albuquerque, New Mexico, 87108-5153, United States

  • Overton Brooks VA Medical Center, Shreveport, LA

    Shreveport, Louisiana, 71101, United States

  • Phoenix VA Health Care System, Phoenix, AZ

    Phoenix, Arizona, 85012, United States

  • Providence VA Medical Center, Providence, RI

    Providence, Rhode Island, 02908, United States

  • Ralph H. Johnson VA Medical Center, Charleston, SC

    Charleston, South Carolina, 29401-5799, United States

  • Salem VA Medical Center, Salem, VA

    Salem, Virginia, 24153, United States

  • Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC

    Salisbury, North Carolina, 28144, United States

  • San Francisco VA Medical Center, San Francisco, CA

    San Francisco, California, 94121-1563, United States

  • South Texas Health Care System, San Antonio, TX

    San Antonio, Texas, 78229, United States

  • Tuscaloosa VA Medical Center, Tuscaloosa, AL

    Tuscaloosa, Alabama, 35404, United States

  • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

    Boston, Massachusetts, 02130-4817, United States

  • VA Connecticut Healthcare System West Haven Campus, West Haven, CT

    West Haven, Connecticut, 06516-2770, United States

  • VA Loma Linda Healthcare System, Loma Linda, CA

    Loma Linda, California, 92357-1000, United States

  • VA Long Beach Healthcare System, Long Beach, CA

    Long Beach, California, 90822, United States

  • VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

    Dallas, Texas, 75216-7167, United States

  • VA Palo Alto Health Care System, Palo Alto, CA

    Palo Alto, California, 94304-1207, United States

  • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

    Pittsburgh, Pennsylvania, 15240, United States

  • VA Puget Sound Health Care System Seattle Division, Seattle, WA

    Seattle, Washington, 98108, United States

  • VA Salt Lake City Health Care System, Salt Lake City, UT

    Salt Lake City, Utah, 84148, United States

  • VA San Diego Healthcare System, San Diego, CA

    San Diego, California, 92161, United States

  • White River Junction VA Medical Center, White River Junction, VT

    White River Junction, Vermont, 05009-0001, United States

  • William S. Middleton Memorial Veterans Hospital, Madison, WI

    Madison, Wisconsin, 53705, United States

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