CSP #2016 - National Adaptive Trial for PTSD Related Insomnia

Who is this study for? Patients with PTSD related insomnia
Status: Recruiting
Location: See all (35) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Ability to comprehend and provision of signed and dated informed consent form

• 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)

• Individuals, between the ages of 18 and 75 years

• Allow digital recording of phone interviews

• PTSD related to military service

• Primary DSM-5 diagnosis of PTSD, assessed by structured interview using the CAPS-5

• Total CAPS-5 score 23

• 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

⁃ 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.

⁃ Females of childbearing potential:

∙ Must have a negative pregnancy test during screening

‣ Must agree not to become pregnant or breastfeed during the course of the study

‣ 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®)

‣ 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)

⁃ Agree to secure firearms while receiving study treatment

⁃ 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)

⁃ Agreement to adhere to Lifestyle Considerations (see Section 5.3) throughout study participation

⁃ 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:

∙ 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.)

‣ If clinically tested, sleep study negative for sleep apnea or results indicating an Apnea-Hypopnea Index (AHI) \< 23 within the past 6 months

‣ If tested for study eligibility, ApneaLink (or equivalent alternative device) result or other sleep study shows AHI \< 23.

Locations
United States
Alabama
Birmingham VA Medical Center, Birmingham, AL
RECRUITING
Birmingham
Tuscaloosa VA Medical Center, Tuscaloosa, AL
RECRUITING
Tuscaloosa
Arizona
Phoenix VA Health Care System, Phoenix, AZ
RECRUITING
Phoenix
California
VA Loma Linda Healthcare System, Loma Linda, CA
TERMINATED
Loma Linda
VA Long Beach Healthcare System, Long Beach, CA
RECRUITING
Long Beach
VA Palo Alto Health Care System, Palo Alto, CA
TERMINATED
Palo Alto
VA San Diego Healthcare System, San Diego, CA
RECRUITING
San Diego
San Francisco VA Medical Center, San Francisco, CA
TERMINATED
San Francisco
Connecticut
CERC (VISN1, West Haven, CT)
RECRUITING
West Haven
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
RECRUITING
West Haven
Florida
Bay Pines VA Healthcare System, Pay Pines, FL
TERMINATED
Bay Pines
Georgia
Atlanta VA Medical and Rehab Center, Decatur, GA
RECRUITING
Decatur
Illinois
Edward Hines Jr. VA Hospital, Hines, IL
TERMINATED
Hines
Louisiana
Overton Brooks VA Medical Center, Shreveport, LA
RECRUITING
Shreveport
Massachusetts
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
TERMINATED
Boston
Minnesota
Minneapolis VA Health Care System, Minneapolis, MN
RECRUITING
Minneapolis
North Carolina
Asheville VA Medical Center, Asheville, NC
RECRUITING
Asheville
Durham VA Medical Center, Durham, NC
TERMINATED
Durham
Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC
ACTIVE_NOT_RECRUITING
Salisbury
New Mexico
New Mexico VA Health Care System, Albuquerque, NM
RECRUITING
Albuquerque
Ohio
Cincinnati VA Medical Center, Cincinnati, OH
TERMINATED
Cincinnati
Louis Stokes VA Medical Center, Cleveland, OH
RECRUITING
Cleveland
Pennsylvania
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
RECRUITING
Philadelphia
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
RECRUITING
Pittsburgh
Rhode Island
Providence VA Medical Center, Providence, RI
RECRUITING
Providence
South Carolina
Ralph H. Johnson VA Medical Center, Charleston, SC
RECRUITING
Charleston
Texas
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
TERMINATED
Dallas
Michael E. DeBakey VA Medical Center, Houston, TX
ACTIVE_NOT_RECRUITING
Houston
South Texas Health Care System, San Antonio, TX
RECRUITING
San Antonio
Utah
VA Salt Lake City Health Care System, Salt Lake City, UT
RECRUITING
Salt Lake City
Virginia
Salem VA Medical Center, Salem, VA
RECRUITING
Salem
Vermont
White River Junction VA Medical Center, White River Junction, VT
RECRUITING
White River Junction
Washington
VA Puget Sound Health Care System Seattle Division, Seattle, WA
RECRUITING
Seattle
Wisconsin
William S. Middleton Memorial Veterans Hospital, Madison, WI
RECRUITING
Madison
Clement J. Zablocki VA Medical Center, Milwaukee, WI
TERMINATED
Milwaukee
Contact Information
Primary
Beverly A Ventura
beverly.ventura@va.gov
(650) 493-5000
Time Frame
Start Date: 2021-02-25
Estimated Completion Date: 2026-02-28
Participants
Target number of participants: 774
Treatments
Active_comparator: Trazodone
Participants who are assigned to take trazodone, an active study medication.
Active_comparator: Eszopiclone
Participants who are assigned to take eszopiclone, an active study medication.
Placebo_comparator: Placebo
Participants who are assigned to take a placebo, a non-active study medication.
Sponsors
Leads: VA Office of Research and Development

This content was sourced from clinicaltrials.gov