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Hypnotic

Medications for PTSD-Related Insomnia (NAP Trial)

Phase 3
Recruiting
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Females of childbearing potential must agree not to become pregnant or breastfeed during the course of the study
Be older than 18 years old
Must not have
Allergy and/or history of intolerance to trazodone hydrochloride and/or eszopiclone, or history of experiencing complex sleep behaviors while taking any sleep medication
Inpatient psychiatric hospitalization within 30 days prior to screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Pivotal Trial

Summary

This trial is testing if taking medications for insomnia can help decrease symptoms of PTSD.

Who is the study for?
This trial is for veterans aged 18-75 with PTSD-related insomnia, who have a significant level of sleep disturbance and PTSD symptoms. Participants must be able to give informed consent, adhere to lifestyle guidelines, and allow phone interview recordings. They should not have severe medical conditions or substance dependence, nor be involved in other clinical studies.
What is being tested?
The study tests if trazodone, eszopiclone, or gabapentin can improve sleep for those with PTSD-related insomnia. It's a comparison against a placebo over approximately 17 weeks. Patients are randomly assigned to one of the medications or placebo without knowing which they receive.
What are the potential side effects?
Potential side effects may include drowsiness, dizziness, nausea, headache and sometimes more complex sleep behaviors like sleepwalking. Each medication has its own profile of possible side effects that participants will be monitored for throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I agree not to become pregnant or breastfeed during the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am allergic or intolerant to trazodone or eszopiclone, or have had complex sleep behaviors with sleep meds.
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I have not been hospitalized for psychiatric reasons in the last 30 days.
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I have not had thoughts of harming myself or others in the last 3 months.
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I have untreated thyroid issues.
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I have dementia, epilepsy, stroke, or am on warfarin.
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I am not taking any medications listed in Appendix A.
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I do not have any serious, unstable medical conditions requiring immediate treatment.
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I have had liver disease for the past six months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Insomnia Severity Index
Secondary study objectives
Clinician Administered PTSD Scale for DSM-5
Generalized Anxiety Disorder-7 Scale
PTSD Checklist
+5 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: TrazodoneActive Control1 Intervention
Participants who are assigned to take trazodone, an active study medication.
Group II: EszopicloneActive Control1 Intervention
Participants who are assigned to take eszopiclone, an active study medication.
Group III: PlaceboPlacebo Group1 Intervention
Participants who are assigned to take a placebo, a non-active study medication.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,663 Previous Clinical Trials
3,426,514 Total Patients Enrolled
25 Trials studying Insomnia
3,442 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

Media Library

Eszopiclone (Hypnotic) Clinical Trial Eligibility Overview. Trial Name: NCT03668041 — Phase 3
Insomnia Research Study Groups: Trazodone, Eszopiclone, Placebo
Insomnia Clinical Trial 2023: Eszopiclone Highlights & Side Effects. Trial Name: NCT03668041 — Phase 3
Eszopiclone (Hypnotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03668041 — Phase 3
Insomnia Patient Testimony for trial: Trial Name: NCT03668041 — Phase 3
~193 spots leftby Feb 2026
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