MedTrace Logo

National Adaptive Trial for PTSD Related Insomnia

NCT03668041 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 673

Last updated 2026-04-02

No results posted yet for this 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.

Conditions

Interventions

DRUG

Trazodone

Trazodone is approved by the Food and Drug Administration (FDA) for treating major depression in adults but not for PTSD. Although trazodone has not been approved by the FDA to treat insomnia or PTSD, some doctors have tried it for these purposes. The doses in this study will be lower than the doses used to treat depression.

DRUG

Eszopiclone

Eszopiclone is approved by the FDA for treating insomnia, but it's unknown if eszopiclone can help treat insomnia when it's related to PTSD. Some doctors have tried it for this purpose. The doses in this study will be the same as the doses used to treat insomnia. A small study found it to be helpful for treating patients with PTSD.

OTHER

Placebo

The active study medications listed above will be compared with a placebo, which is a pill that looks like a study medication but has no medication in it.

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • John H. Krystal, MD · VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-25
Primary Completion
2026-03-30
Completion
2026-03-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03668041 on ClinicalTrials.gov