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NCT03668041 · ClinicalTrials.gov registry record · Phase 3
National Adaptive Trial for PTSD Related Insomnia
A Phase 3 study of Insomnia, sponsored by VA Office of Research and Development.
- Active
- Registry status
- Phase 3
- Development phase
- 673
- Enrollment target
- 20
- Study locations
NCT03668041: Active Phase 3 study of Insomnia, sponsored by VA Office of Research and Development.
NCT03668041 is a Phase 3 study of Insomnia that is active but no longer recruiting, run by VA Office of Research and Development. The registered enrollment target is 673 participants, above the 166-participant average among 151 other Insomnia trials with a reported enrollment target (305% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03668041, a Phase 3 study of Insomnia, is active but no longer recruiting, sponsored by VA Office of Research and Development.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 673 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Change in the Insomnia Severity Index score from baseline to the 12-week follow-up will serve as the primary outcome. Possible range for ISI 0-28. Higher score indicates more severe insomnia problem(s). 0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe)
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 |
What the registry record for NCT03668041 still lists
NCT03668041 is an interventional study that assigns participants to a tested intervention. The registered 673 participants enrollment target is mid-sized for trials with a published cap, above the 166-participant average among 151 other Insomnia trials with a reported enrollment target (305% higher).
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.
NCT03668041 names 20 study sites across 12 states, led by California, North Carolina, Alabama.
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.
What interventions are being tested in trial NCT03668041?
The interventions under investigation include: Placebo (OTHER), Trazodone (DRUG), Eszopiclone (DRUG).
Who is sponsoring clinical trial NCT03668041?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Insomnia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03668041's enrollment target sits among peer trials
673 7th of 151 higher than 145 of 151 other Insomnia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Insomnia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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