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Prazosin in Veterans with Mild Traumatic Brain Injury

Recruiting

Mild traumatic brain injury (TBI) from explosions is a common injury of veterans, and multiple mild TBIs can lead to chronic traumatic encephalopathy (CTE) and Alzheimer's disease years later. This study will test the approved drug prazosin in veterans who have experienced mild TBIs to explore its effects on biomarkers of these diseases. 

Minimum Age Maximum Age Gender Healthy Volunteers
21 Years N/A All No
December 2016
June 30, 2024
120

  • Ability to complete psychometric and other assessments in English
  • No significant abnormal results of laboratory tests at screening
  • Platelet count greater than 100,000/mm2 within 2 weeks of lumbar puncture
  • Body mass index of 18 to 36
  • If female and of childbearing potential, must abstain from sexual relations that could result in pregnancy or use birth control
  • History of mild or moderate TBI or diagnosis of post-traumatic stress disorder related to combat trauma

  • History of severe TBI
  • Acute or unstable chronic medical illness, including unstable angina, heart attack within past 6 months, congestive heart failure, preexisting hypotension or orthostatic hypotension, autoimmune disorders, insulin-dependent diabetes, chronic kidney or liver failure, acute pancreatitis, vertigo, narcolepsy, or untreated sleep apnea 
  • Inability to undergo lumbar puncture due to spinal cord injury, use of anticoagulant medications, infection in previous 4 weeks, or other reason
  • Pregnant or lactating
  • Schizophrenia, schizoaffective disorder, other psychotic disorder, delirium, or any cognitive disorder
  • Substance use disorder other than in remission for at least 3 months 
  • Use of drugs illegal under Washington state law
  • Severe psychiatric instability or situational life crises or any behavior that poses an immediate danger
  • Use of prazosin or other alpha-1 antagonist or trazodone within past 3 months
  • Allergy or previous adverse reaction to prazosin or other alpha-1 antagonist
  • Use of exclusionary medications in the 4 weeks prior to screening: antipsychotics, anti-Parkinson's disease medications, central nervous system stimulants, Coumadin (warfarin) or other medications affecting coagulation and/or inflammation (low-dose aspirin and NSAIDs are allowed), potent immune-modulating medications (e.g., hydrocortisone or methotrexate), and anti-HIV medications
  • Use of certain erectile dysfunction medications during study dose titration period (will be allowed at one-half the usual starting dose following dose titration)
  • Use of stimulants or nitrates, or of alternative medications or supplements with stimulant properties (e.g., ephedra) or vasodilatory properties (e.g., nitrate-containing supplements)
  • Trauma- or sleep-focused psychotherapy within 4 weeks of first baseline assessment
  • Receiving another study medication

Prazosin is a drug approved to treat several conditions, including high blood pressure and sleep problems associated with post-traumatic stress disorder. Researchers believe the drug may also be used to decrease the accumulation of proteins in the brain associated with CTE and Alzheimers disease. Participants will take a pill of either prazosin or a placebo three times a day for 10 weeks. Researchers will measure whether prazosin reduces the amount of tau and beta-amyloid (proteins found in the brain of people with Alzheimer's) in the spinal fluid that surrounds the brain to determine if prazosin could be a possible preventive treatment for CTE and Alzheimer's disease in future studies.

Name City State Zip Status Primary Contact
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle Washington 98108 Recruiting Murray A Raskind, MD
206-764-2702
murray.raskind@va.gov

VA Office of Research and Development

Name Role Affiliation
Murray A. Raskind, MD Principal Investigator VA Puget Sound Health Care System Seattle Division

Name Phone Email
Murray A. Raskind, MD 206-764-2702 murray.raskind@va.gov
Hollie A. Holmes 206-277-6207 hollie.holmes@va.gov

NCT03221751

Prazosin and CSF Biomarkers in mTBI