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Prazosin in Veterans with Mild Traumatic Brain Injury

Start: December 2016
End: June 30, 2025
Enrollment: 120

What Is This Study About?

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. 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 Alzheimer's disease. This study will test prazosin in veterans who have experienced mild TBIs to explore whether it may be a possible preventive treatment. Participants will take a pill of either prazosin or a placebo three times a day for 10 weeks.

Do I Qualify To Participate in This Study?

Minimum Age: 21 Years

Maximum Age: N/A

Must have:

  • 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

Must NOT have:

  • 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

If I Qualify, Who Do I Contact?

Contact study personnel listed either under the general study contact or the location nearest you.

 

Need Help?

Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.

Where Is This Study Located?

Who Sponsors This Study?

Lead: VA Office of Research and Development

Source: ClinicalTrials.gov ID: NCT03221751