Study Summary
This trial is testing if taking medications for insomnia can help decrease symptoms of PTSD.
Eligible Conditions
- Insomnia
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
1 Primary · 8 Secondary · Reporting Duration: 12 weeks
12 weeks
Clinician Administered PTSD Scale for DSM-5
Generalized Anxiety Disorder-7 Scale
PTSD Checklist
Patient Health Questionnaire-9
Pittsburgh Sleep Quality Index Scale-Addendum for PTSD
Service Utilization and Resources Form
The World Health Organization Quality of Life
Treatment Satisfaction Questionnaire for Medication-9
Baseline to 12 weeks
Insomnia Severity Index
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
4 Treatment Groups
Gabapentin
1 of 4
Trazodone
1 of 4
Eszopiclone
1 of 4
Placebo
1 of 4
Active Control
Non-Treatment Group
1224 Total Participants · 4 Treatment Groups
Primary Treatment: Gabapentin · Has Placebo Group · Phase 3
Gabapentin
Drug
ActiveComparator Group · 1 Intervention: Gabapentin · Intervention Types: DrugTrazodone
Drug
ActiveComparator Group · 1 Intervention: Trazodone · Intervention Types: DrugEszopiclone
Drug
ActiveComparator Group · 1 Intervention: Eszopiclone · Intervention Types: DrugPlacebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: OtherTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 weeks
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,485 Previous Clinical Trials
2,740,995 Total Patients Enrolled
25 Trials studying Insomnia
3,559 Patients Enrolled for Insomnia
John H. Krystal, MDStudy ChairVA Connecticut Healthcare System West Haven Campus, West Haven, CT
1 Previous Clinical Trials
163 Total Patients Enrolled
Eligibility Criteria
Age 18 - 75 · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are between the ages of 18 and 75 years.
You have a total CAPS-5 score of 26 or higher.
You are willing to comply with all study procedures and are available for the duration of the study.
You have a primary diagnosis of PTSD, assessed by structured interview using the CAPS-5.
Who else is applying?
What state do they live in?
| Oklahoma | 66.7% |
| California | 33.3% |
What site did they apply to?
| VA Long Beach Healthcare System, Long Beach, CA | 50.0% |
| VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX | 50.0% |
What portion of applicants met pre-screening criteria?
| Did not meet criteria | 33.3% |
| Met criteria | 66.7% |
References
- Krystal, John H., Bruce Chow, Jennifer Vessicchio, Adam M. Henrie, Thomas C. Neylan, Andrew D. Krystal, Brian P. Marx, et al.. 2021. “Design of the National Adaptive Trial for Ptsd-related Insomnia (NAP Study), VA Cooperative Study Program (CSP) #2016”. Contemporary Clinical Trials. Elsevier BV. doi:10.1016/j.cct.2021.106540.
- Krystal, John H., Bruce Chow, Jennifer Vessicchio, Adam M. Henrie, Thomas C. Neylan, Andrew D. Krystal, Brian P. Marx, et al.. 2021. “Design of the National Adaptive Trial for Ptsd-related Insomnia (NAP Study), VA Cooperative Study Program (CSP) #2016”. Contemporary Clinical Trials. Elsevier BV. doi:10.1016/j.cct.2021.106540.
- 2021. "National Adaptive Trial for PTSD Related Insomnia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03668041.
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Conditions
Cancer Related
Treatments