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National Adaptive Trial for PTSD Related Insomnia
NCT03668041 · View on ClinicalTrials.gov ↗
Study Summary
Many Veterans with posttraumatic stress disorder (PTSD) have trouble sleeping or have frequent nightmares. So far, no medication has been approved for treatment of insomnia in PTSD. The purpose of this research study is to find out if taking medications called trazodone or eszopiclone can help decrease symptoms of insomnia in patients with PTSD. PTSD is a form of intense anxiety which sometimes results from severe trauma. Symptoms may include nightmares, flashbacks, troublesome memories, difficulty sleeping, poor concentration, irritability, anger, and emotional withdrawal. Insomnia is a disorder that can make it hard to fall sleep, stay asleep or cause a person to wake up too early and not be able to fall back to sleep.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Trazodone
- DRUG Eszopiclone
Study Locations (20)
California
- VA Loma Linda Healthcare System, Loma Linda, CA — Loma Linda
- VA Long Beach Healthcare System, Long Beach, CA — Long Beach
- VA Palo Alto Health Care System, Palo Alto, CA — Palo Alto
- VA San Diego Healthcare System, San Diego, CA — San Diego
- San Francisco VA Medical Center, San Francisco, CA — San Francisco
North Carolina
- Asheville VA Medical Center, Asheville, NC — Asheville
- Durham VA Medical Center, Durham, NC — Durham
- Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC — Salisbury
Alabama
- Birmingham VA Medical Center, Birmingham, AL — Birmingham
- Tuscaloosa VA Medical Center, Tuscaloosa, AL — Tuscaloosa
Connecticut
- VA Connecticut Healthcare System West Haven Campus, West Haven, CT — West Haven
- CERC (VISN1, West Haven, CT) — West Haven
Arizona
- Phoenix VA Health Care System, Phoenix, AZ — Phoenix
Florida
- Bay Pines VA Healthcare System, Pay Pines, FL — Bay Pines
Georgia
- Atlanta VA Medical and Rehab Center, Decatur, GA — Decatur
Illinois
- Edward Hines Jr. VA Hospital, Hines, IL — Hines
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 673 participants |
| Start Date | 2021-02-25 |
| Est. Completion | 2026-03-31 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03668041
The ClinicalTrials.gov registry entry for NCT03668041 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 673 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is VA Office of Research and Development, which has 1,863 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Insomnia appearing as the primary indexed condition, and to 3 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03668041 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, North Carolina, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03668041 about?
NCT03668041 is a clinical study titled "National Adaptive Trial for PTSD Related Insomnia". Many Veterans with posttraumatic stress disorder (PTSD) have trouble sleeping or have frequent nightmares. So far, no medication has been approved for treatment of insomnia in PTSD. The purpose of this research study is to find out if taking medications called trazodone or eszopiclone can help decre...
What is the current status of trial NCT03668041?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 673 participants. The study started on 2021-02-25. Estimated completion is 2026-03-31.
What conditions does trial NCT03668041 study?
This clinical trial studies the following conditions: Insomnia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03668041?
The interventions under investigation include: Placebo (OTHER), Trazodone (DRUG), Eszopiclone (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03668041?
This trial is sponsored by VA Office of Research and Development, which has 1,863 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03668041 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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