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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
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.Check my eligibility
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.See study design
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 belowSelect...
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:Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Insomnia Severity Index
Secondary outcome measures
Clinician Administered PTSD Scale for DSM-5
Generalized Anxiety Disorder-7 Scale
PTSD Checklist
+5 moreTrial 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.
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,628 Previous Clinical Trials
3,325,205 Total Patients Enrolled
26 Trials studying Insomnia
3,512 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You agree to follow specific lifestyle guidelines during the study (see Section 5.3).My sleep apnea is under control with treatment.I have not had thoughts of harming myself or others in the last 3 months.I have untreated thyroid issues.I have dementia, epilepsy, stroke, or am on warfarin.I am not taking any medications listed in Appendix A.I started my evidence-based psychotherapy at least 60 days before screening.My sleep apnea is well-managed or I don't have severe sleep apnea.I am allergic or intolerant to trazodone or eszopiclone, or have had complex sleep behaviors with sleep meds.I have not been hospitalized for psychiatric reasons in the last 30 days.I plan to work during the study period.I agree not to become pregnant or breastfeed during the study.I am willing to use effective birth control for 16 weeks during and after the study.I do not have any serious, unstable medical conditions requiring immediate treatment.I started my therapy for mental health over 60 days ago.I have had liver disease for the past six months.I am between 18 and 75 years old.I am of childbearing age and my pregnancy test was negative.I am willing and available to follow the study rules for about 17 weeks.Your total CAPS-5 score is 26 or higher.
Research Study Groups:
This trial has the following groups:- Group 1: Trazodone
- Group 2: Eszopiclone
- Group 3: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Insomnia Patient Testimony for trial: Trial Name: NCT03668041 — Phase 3
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