National Adaptive Trial for PTSD Related Insomnia

PHASE3RecruitingINTERVENTIONAL
Enrollment

774

Participants

Timeline

Start Date

February 25, 2021

Primary Completion Date

February 28, 2026

Study Completion Date

February 28, 2026

Conditions
Insomnia
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.

Trial Locations (35)

15240

RECRUITING

VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA, Pittsburgh

19104

RECRUITING

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

24153

RECRUITING

Salem VA Medical Center, Salem, VA, Salem

28144

ACTIVE_NOT_RECRUITING

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

28805

RECRUITING

Asheville VA Medical Center, Asheville, NC, Asheville

30033

RECRUITING

Atlanta VA Medical and Rehab Center, Decatur, GA, Decatur

35233

RECRUITING

Birmingham VA Medical Center, Birmingham, AL, Birmingham

35404

RECRUITING

Tuscaloosa VA Medical Center, Tuscaloosa, AL, Tuscaloosa

44106

RECRUITING

Louis Stokes VA Medical Center, Cleveland, OH, Cleveland

53705

RECRUITING

William S. Middleton Memorial Veterans Hospital, Madison, WI, Madison

55417

RECRUITING

Minneapolis VA Health Care System, Minneapolis, MN, Minneapolis

71101

RECRUITING

Overton Brooks VA Medical Center, Shreveport, LA, Shreveport

78229

RECRUITING

South Texas Health Care System, San Antonio, TX, San Antonio

84148

RECRUITING

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

85012

RECRUITING

Phoenix VA Health Care System, Phoenix, AZ, Phoenix

90822

RECRUITING

VA Long Beach Healthcare System, Long Beach, CA, Long Beach

92161

RECRUITING

VA San Diego Healthcare System, San Diego, CA, San Diego

98108

RECRUITING

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

92357-1000

TERMINATED

VA Loma Linda Healthcare System, Loma Linda, CA, Loma Linda

94304-1207

TERMINATED

VA Palo Alto Health Care System, Palo Alto, CA, Palo Alto

94121-1563

TERMINATED

San Francisco VA Medical Center, San Francisco, CA, San Francisco

06516-2770

RECRUITING

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

06516

RECRUITING

CERC (VISN1, West Haven, CT), West Haven

33744-0000

TERMINATED

Bay Pines VA Healthcare System, Pay Pines, FL, Bay Pines

60141-3030

TERMINATED

Edward Hines Jr. VA Hospital, Hines, IL, Hines

02130-4817

TERMINATED

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

87108-5153

RECRUITING

New Mexico VA Health Care System, Albuquerque, NM, Albuquerque

27705-3875

TERMINATED

Durham VA Medical Center, Durham, NC, Durham

45220-2213

TERMINATED

Cincinnati VA Medical Center, Cincinnati, OH, Cincinnati

02908

RECRUITING

Providence VA Medical Center, Providence, RI, Providence

29401-5799

RECRUITING

Ralph H. Johnson VA Medical Center, Charleston, SC, Charleston

75216-7167

TERMINATED

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

77030-4211

ACTIVE_NOT_RECRUITING

Michael E. DeBakey VA Medical Center, Houston, TX, Houston

05009-0001

RECRUITING

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

53295-0001

TERMINATED

Clement J. Zablocki VA Medical Center, Milwaukee, WI, Milwaukee

All Listed Sponsors
lead

VA Office of Research and Development

FED