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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

NAP 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.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.

NAP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I agree not to become pregnant or breastfeed during the study.

NAP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

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

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 more

NAP 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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor

1,611 Previous Clinical Trials

3,304,510 Total Patients Enrolled

26 Trials studying Insomnia

3,423 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there several clinics running this clinical trial in the city?

"There are 35 sites associated with this trial, which can be found in Salisbury, Birmingham and West Haven among other locations. Selecting the site closest to you may reduce travel burdens if you enroll in the study."

Answered by AI

How many individuals are being asked to take part in this experiment?

"In order to have this clinical trial run as planned, 1224 participants that fit the bill are necessary. These individuals can choose to be involved at different sites, such as Salisbury W.G. (Bill) Hefner VA Medical Center in Salisbury, North carolina and Birmingham VA Medical Center in Birmingham, Alabama."

Answered by AI

Do doctors believe that Eszopiclone is safe for their patients to take?

"Eszopiclone is considered safe according to our team's evaluation because it has reached Phase 3 clinical trials. This milestone is only achieved when a medication demonstrates some efficacy and multiple rounds of data supporting safety."

Answered by AI

Could you list the prerequisites for joining this particular medical study?

"This trial is looking for 1224 patients with sleeplessness between the ages of 18 and 75 who meet the following criteria: Ability to comprehend and provision of signed and dated informed consent form, Individuals, between the ages of 18 and 75 years, Allow digital recording of phone interviews, PTSD related to military service, ISI >15, Screening clinical laboratory tests without clinically significant abnormalities that would make study participation inappropriate, as determined by the site investigator with input, if needed, from the study chair. Total CAPS-5 score 26 , Electrocardiogram (ECG) at baseline without clinically significant abnormalities that would make study participation inappropriate ,"

Answered by AI

What are the primary medical reasons that Eszopiclone is prescribed?

"Eszopiclone is frequently used to help those with eating disorders but it can also be prescribed to patients suffering from neuralgia, pain, or major depressive disorder."

Answered by AI

Is this research project still accepting new participants?

"That is correct. The information available from clinicaltrials.gov suggests that this trial is actively recruiting patients at 35 different sites. To date, 1224 individuals have been enrolled in the study."

Answered by AI

Are Eszopiclone's clinical trials unique in comparison to other drugs?

"At the moment, there are 36 ongoing trials studying Eszopiclone with 12 of those in Phase 3. Most investigations into Eszopiclone are taking place in Columbus, Ohio; however, 95 different locations around the world are running similar studies."

Answered by AI

Who else is applying?

What state do they live in?

California

New York

Texas

Other

What site did they apply to?

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

South Texas Health Care System, San Antonio, TX

VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Other

What portion of applicants met pre-screening criteria?

Met criteria

Did not meet criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

I generally prefer to do thing that are not in the norm and have wanted to check out the remote one for a long time.

PatientReceived no prior treatments

I've suffered from insomnia for many years. Ambien and Lunesta made me do very strange things. So I've resorted to taking Melatonin which my insomnia laughs at or Unisom which might allow me to fall asleep for 2 hours after which I'm wide awake for the remainder of the night.

PatientReceived 1 prior treatment

I have tried 2 drugs in the past. I have no total relief. It's like I'm never really fully asleep when I do fall asleep. I have dreams and talk in my sleep. And if you just call my name, I wake up and can tell them exactly what I was dreaming about. So I have quite an active nightlife going on when I fall asleep in a low-level sleep realm.

PatientReceived 1 prior treatment