ACTIVE_NOT_RECRUITING

National Adaptive Trial for PTSD Related Insomnia

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

CSP #2016 - National Adaptive Trial for PTSD Related Insomnia

Quick Facts

Study Start:2021-02-25

Study Completion:2026-02-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03668041

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Ability to comprehend and provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study (approximately 17 weeks from the date of being randomized) 3. Individuals, between the ages of 18 and 75 years 4. Allow digital recording of phone interviews 5. PTSD related to military service 6. Primary DSM-5 diagnosis of PTSD, assessed by structured interview using the CAPS-5 7. Total CAPS-5 score 23 8. ISI \>15 9. 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 10. Electrocardiogram (ECG) at baseline without clinically significant abnormalities that would make study participation inappropriate, as determined by the site investigator with input, if needed, from the study chair and/or contingent upon approval by consulting medical physician. 11. Females of childbearing potential: 1. Must have a negative pregnancy test during screening 2. Must agree not to become pregnant or breastfeed during the course of the study 3. Must be willing to use a reliable form of contraception for 16 weeks (during study treatment and for 2 weeks after taking the last dose) which includes: barrier contraceptives (male or female condoms with or without a spermicide, diaphragm or cervical cap with spermicide, or intrauterine device) and hormone-based therapy (contraceptive pills, intrauterine devices, or Depo-Provera®) 4. Birth control for female participants is not necessary if surgically sterile or if with a partner with whom they are not capable of conceiving children (defined as a surgically sterile female by hysterectomy, bilateral oophorectomy, or bilateral tubal ligation; surgically sterile male who has undergone a complete orchiectomy or successful vasectomy; or a same sex partner) 12. Agree to secure firearms while receiving study treatment 13. If individuals are undergoing evidence-based psychotherapy (EBT), which includes cognitive behavioral therapy (CBT), cognitive processing therapy (CPT), prolonged exposure therapy (PE), and/or stress inoculation therapy (SIT), they must have started these therapies at least 60 days prior to starting screening. If screening is started, and it is then discovered that EBT was started within 60 days prior to screening, participants must wait at least 60 days since staring the new EBT before they can complete the screening ISI, the screening PCL, and the Phone Assessment. (Supportive individual and group therapy is allowed) 14. Agreement to adhere to Lifestyle Considerations (see Section 5.3) throughout study participation 15. Clinical evidence of adequately treated sleep apnea or absence of sleep apnea having a severity that would make study participation problematic, established by meeting one of the criteria below: 1. Clinical evidence of adequately treated sleep apnea with a continuous positive airway pressure (CPAP) or alternative treatment device (as defined in Section 8.1) (Participants can be reevaluated at least 30 days after screen failure.) 2. If clinically tested, sleep study negative for sleep apnea or results indicating an Apnea-Hypopnea Index (AHI) \< 23 within the past 6 months 3. If tested for study eligibility, ApneaLink (or equivalent alternative device) result or other sleep study shows AHI \< 23.	1. Currently enrolled in any other interventional study unless prior approval is provided by the study team (It is a CSP policy that exemptions will be assessed for individual patients on a case-by-case basis. Exemptions require the agreement in writing of the following individuals or groups: (1) the SIs of both studies; (2) the Study Chairs of the involved studies; (3) the appropriate CSP Center Director(s); and (4) the VA Central IRB.) 2. Allergy and/or history of intolerance to trazodone hydrochloride and/or eszopiclone, or history of experiencing complex sleep behaviors (i.e., sleep walking, sleep driving, and/or engaging in other activities while not fully awake) while taking any sleep medication 3. A comorbid current or lifetime diagnosis of bipolar I disorder, bipolar II disorder, schizoaffective disorder, schizophrenia or delusional disorder, or current comorbid diagnosis of schizophreniform disorder, brief psychotic disorder, psychotic disorder due to a general medical condition, substance-induced psychotic disorder or psychotic disorder not otherwise specified (NOS) according to Structured Clinical Interview for DSM-5 (SCID)-I-RV/P 4. History of moderate or severe traumatic brain injury (TBI) or history of gross structural damage as shown on MRI. 5. Positive urine test for an illicit substance, excluding cannabis, within the past 90 days prior to screening 6. Substance use meeting DSM-5 criteria for moderate or severe dependence (excluding nicotine) within the past 12 months prior to screening. (Note: Current mild dependence for alcohol and cannabis use is acceptable, but current mild dependence of any other substances is exclusionary.) 7. Inpatient psychiatric hospitalization within 30 days prior to screening 8. Suicidal or homicidal ideation with intent or plan to harm themselves or others within 90 days prior to screening 9. Chronic liver disease with two or more of the following occurring within the past six months: international normalized ratio (INR) greater than or equal to 1.7 (not on warfarin therapy), bilirubin greater than or equal to 2 mg/dL, serum albumin less than or equal to 3.5 g/dL, ascites, or encephalopathy (Participants can be reevaluated in 30 days) 10. Clinical and laboratory evidence of untreated hypothyroidism or hyperthyroidism 11. A corrected QT (QTc) interval greater than 470 ms 12. Unstable, serious medical condition or one requiring acute medical treatment, or planned hospitalization for extended care 13. Dementia, epilepsy, stroke, or current treatment with warfarin for anticoagulation 14. Taking any of the exclusionary medications listed in Appendix A. Note- an individual taking one of these medications for the sole purpose of improving sleep that elects to undergo an adequate wash-out period of at least 5 half-lives of the parent compound or active metabolite (e.g., for medications like diazepam), under the care of the individual's clinical provider, would not be excluded by this criterion. 15. Under criminal investigation or pending legal charges with potential incarceration 16. Individuals who lack stable contact information (including lack of a telephone number) 17. Participants who anticipate working during the hours of midnight to 6am during the course of study trial 18. Participants with narcolepsy

Inclusion Criteria

Exclusion Criteria

1. Ability to comprehend and provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study (approximately 17 weeks from the date of being randomized)
3. Individuals, between the ages of 18 and 75 years
4. Allow digital recording of phone interviews
5. PTSD related to military service
6. Primary DSM-5 diagnosis of PTSD, assessed by structured interview using the CAPS-5
7. Total CAPS-5 score 23
8. ISI \>15
9. 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
10. Electrocardiogram (ECG) at baseline without clinically significant abnormalities that would make study participation inappropriate, as determined by the site investigator with input, if needed, from the study chair and/or contingent upon approval by consulting medical physician.
11. Females of childbearing potential:
1. Must have a negative pregnancy test during screening
2. Must agree not to become pregnant or breastfeed during the course of the study
3. Must be willing to use a reliable form of contraception for 16 weeks (during study treatment and for 2 weeks after taking the last dose) which includes: barrier contraceptives (male or female condoms with or without a spermicide, diaphragm or cervical cap with spermicide, or intrauterine device) and hormone-based therapy (contraceptive pills, intrauterine devices, or Depo-Provera®)
4. Birth control for female participants is not necessary if surgically sterile or if with a partner with whom they are not capable of conceiving children (defined as a surgically sterile female by hysterectomy, bilateral oophorectomy, or bilateral tubal ligation; surgically sterile male who has undergone a complete orchiectomy or successful vasectomy; or a same sex partner)
12. Agree to secure firearms while receiving study treatment
13. If individuals are undergoing evidence-based psychotherapy (EBT), which includes cognitive behavioral therapy (CBT), cognitive processing therapy (CPT), prolonged exposure therapy (PE), and/or stress inoculation therapy (SIT), they must have started these therapies at least 60 days prior to starting screening. If screening is started, and it is then discovered that EBT was started within 60 days prior to screening, participants must wait at least 60 days since staring the new EBT before they can complete the screening ISI, the screening PCL, and the Phone Assessment. (Supportive individual and group therapy is allowed)
14. Agreement to adhere to Lifestyle Considerations (see Section 5.3) throughout study participation
15. Clinical evidence of adequately treated sleep apnea or absence of sleep apnea having a severity that would make study participation problematic, established by meeting one of the criteria below:
1. Clinical evidence of adequately treated sleep apnea with a continuous positive airway pressure (CPAP) or alternative treatment device (as defined in Section 8.1) (Participants can be reevaluated at least 30 days after screen failure.)
2. If clinically tested, sleep study negative for sleep apnea or results indicating an Apnea-Hypopnea Index (AHI) \< 23 within the past 6 months
3. If tested for study eligibility, ApneaLink (or equivalent alternative device) result or other sleep study shows AHI \< 23.

1. Currently enrolled in any other interventional study unless prior approval is provided by the study team (It is a CSP policy that exemptions will be assessed for individual patients on a case-by-case basis. Exemptions require the agreement in writing of the following individuals or groups: (1) the SIs of both studies; (2) the Study Chairs of the involved studies; (3) the appropriate CSP Center Director(s); and (4) the VA Central IRB.)
2. Allergy and/or history of intolerance to trazodone hydrochloride and/or eszopiclone, or history of experiencing complex sleep behaviors (i.e., sleep walking, sleep driving, and/or engaging in other activities while not fully awake) while taking any sleep medication
3. A comorbid current or lifetime diagnosis of bipolar I disorder, bipolar II disorder, schizoaffective disorder, schizophrenia or delusional disorder, or current comorbid diagnosis of schizophreniform disorder, brief psychotic disorder, psychotic disorder due to a general medical condition, substance-induced psychotic disorder or psychotic disorder not otherwise specified (NOS) according to Structured Clinical Interview for DSM-5 (SCID)-I-RV/P
4. History of moderate or severe traumatic brain injury (TBI) or history of gross structural damage as shown on MRI.
5. Positive urine test for an illicit substance, excluding cannabis, within the past 90 days prior to screening
6. Substance use meeting DSM-5 criteria for moderate or severe dependence (excluding nicotine) within the past 12 months prior to screening. (Note: Current mild dependence for alcohol and cannabis use is acceptable, but current mild dependence of any other substances is exclusionary.)
7. Inpatient psychiatric hospitalization within 30 days prior to screening
8. Suicidal or homicidal ideation with intent or plan to harm themselves or others within 90 days prior to screening
9. Chronic liver disease with two or more of the following occurring within the past six months: international normalized ratio (INR) greater than or equal to 1.7 (not on warfarin therapy), bilirubin greater than or equal to 2 mg/dL, serum albumin less than or equal to 3.5 g/dL, ascites, or encephalopathy (Participants can be reevaluated in 30 days)
10. Clinical and laboratory evidence of untreated hypothyroidism or hyperthyroidism
11. A corrected QT (QTc) interval greater than 470 ms
12. Unstable, serious medical condition or one requiring acute medical treatment, or planned hospitalization for extended care
13. Dementia, epilepsy, stroke, or current treatment with warfarin for anticoagulation
14. Taking any of the exclusionary medications listed in Appendix A. Note- an individual taking one of these medications for the sole purpose of improving sleep that elects to undergo an adequate wash-out period of at least 5 half-lives of the parent compound or active metabolite (e.g., for medications like diazepam), under the care of the individual's clinical provider, would not be excluded by this criterion.
15. Under criminal investigation or pending legal charges with potential incarceration
16. Individuals who lack stable contact information (including lack of a telephone number)
17. Participants who anticipate working during the hours of midnight to 6am during the course of study trial
18. Participants with narcolepsy

Contacts and Locations

Principal Investigator

John H. Krystal, MD

STUDY_CHAIR

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

Study Locations (Sites)

Birmingham VA Medical Center, Birmingham, AL

Birmingham, Alabama, 35233

United States

Tuscaloosa VA Medical Center, Tuscaloosa, AL

Tuscaloosa, Alabama, 35404

United States

Phoenix VA Health Care System, Phoenix, AZ

Phoenix, Arizona, 85012

United States

VA Loma Linda Healthcare System, Loma Linda, CA

Loma Linda, California, 92357-1000

United States

VA Long Beach Healthcare System, Long Beach, CA

Long Beach, California, 90822

United States

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1207

United States

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161

United States

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, 94121-1563

United States

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

West Haven, Connecticut, 06516-2770

United States

CERC (VISN1, West Haven, CT)

West Haven, Connecticut, 06516

United States

Bay Pines VA Healthcare System, Pay Pines, FL

Bay Pines, Florida, 33744-0000

United States

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, 30033

United States

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, 60141-3030

United States

Overton Brooks VA Medical Center, Shreveport, LA

Shreveport, Louisiana, 71101

United States

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, 02130-4817

United States

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417

United States

New Mexico VA Health Care System, Albuquerque, NM

Albuquerque, New Mexico, 87108-5153

United States

Asheville VA Medical Center, Asheville, NC

Asheville, North Carolina, 28805

United States

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705-3875

United States

Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC

Salisbury, North Carolina, 28144

United States

Cincinnati VA Medical Center, Cincinnati, OH

Cincinnati, Ohio, 45220-2213

United States

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, 44106

United States

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Philadelphia, Pennsylvania, 19104

United States

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Pittsburgh, Pennsylvania, 15240

United States

Providence VA Medical Center, Providence, RI

Providence, Rhode Island, 02908

United States

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5799

United States

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

Dallas, Texas, 75216-7167

United States

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030-4211

United States

South Texas Health Care System, San Antonio, TX

San Antonio, Texas, 78229

United States

VA Salt Lake City Health Care System, Salt Lake City, UT

Salt Lake City, Utah, 84148

United States

White River Junction VA Medical Center, White River Junction, VT

White River Junction, Vermont, 05009-0001

United States

Salem VA Medical Center, Salem, VA

Salem, Virginia, 24153

United States

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108

United States

William S. Middleton Memorial Veterans Hospital, Madison, WI

Madison, Wisconsin, 53705

United States

Clement J. Zablocki VA Medical Center, Milwaukee, WI

Milwaukee, Wisconsin, 53295-0001

United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-02-25

Study Completion Date2026-02-28

Study Record Updates

Study Start Date2021-02-25

Study Completion Date2026-02-28

Terms related to this study

Additional Relevant MeSH Terms

Insomnia