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Combined Behavioral and Pharmacologic Therapy for Insomnia (PRECEPT-D Trial)

Phase 4

Waitlist Available

Led By Ali A El-Solh, MD MPH

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

Diagnosis of PTSD as determined by the intake conducted through the PTSD Clinic or the Mental Health Clinic

Age >18 years and <65 years old

Must not have

Treatment for seizure disorders

History of clinically significant hepatic impairment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up repeated measures between baseline and 6 months post randomization

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial is testing whether adding a sleep medication to cognitive behavioral therapy for insomnia will help improve sleep quality, PTSD severity, and CPAP adherence in veterans with both PTSD and obstructive sleep apnea.

Who is the study for?

This trial is for Veterans with PTSD, aged 18-65, who have both obstructive sleep apnea and chronic insomnia. They must be stable on psychotherapeutic treatments and not adherent to CPAP therapy. Exclusions include significant liver issues, eszopiclone sensitivity, pain-related insomnia, alcohol overuse, certain psychiatric or substance abuse disorders.

What is being tested?

The study tests if combining cognitive behavioral therapy (CBT) for insomnia with a sleeping pill called eszopiclone improves sleep quality, PTSD severity, and adherence to CPAP treatment in Veterans compared to CBT alone.

What are the potential side effects?

Eszopiclone may cause drowsiness during the day, headaches, dizziness; rare side effects include complex nocturnal behaviors like sleepwalking. Behavioral therapy typically has no direct physical side effects.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with PTSD by a specialized clinic.

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I am between 18 and 65 years old.

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I understand the study and can agree to participate.

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I have been experiencing insomnia for more than 3 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am receiving treatment for seizures.

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I have a history of serious liver problems.

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My insomnia is caused by pain.

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I have been diagnosed with schizophrenia or schizoaffective disorder.

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I have been diagnosed with bipolar disorder.

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I am taking strong medications that I cannot or should not stop.

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I have had complex behaviors at night while on eszopiclone.

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I am not willing to use CPAP.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ repeated measures between baseline and 6 months post randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~repeated measures between baseline and 6 months post randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and repeated measures between baseline and 6 months post randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Pittsburgh Sleep Quality Index (PSQI) (32)

Secondary study objectives

Change in Beck Depression Inventory-II (BDI-II)

Change in Insomnia Severity Index (ISI)

Change in PTSD checklist-5 (PCL-5)

Other study objectives

CPAP adherence

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

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

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: BBTI plus eszopicloneExperimental Treatment2 Interventions

participants randomized to the combination therapy will receive eszopiclone 2 mg orally at bedtime or placebo starting with the BBTI sessions for a period of 2 weeks in combination with 4 sessions of BBTI over 4 weeks.

Group II: BBTIActive Control1 Intervention

participants randomized to BBTI will receive 4 sessions of BBTI over 4 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

eszopiclone

2006

Completed Phase 4

~1630

0 / 12Eligibility criteria met