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Trifecta Research Study

Launched by JOHNS HOPKINS UNIVERSITY · Feb 4, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Ptsd Military Veteran Cognitive Functioning Traumatic Brain Injury (Tbi) Psychedelics Transcranial Magnetic Stimulation (Tms)

ClinConnect Summary

The Trifecta Research Study is looking into new treatments for veterans who have experienced combat and are dealing with conditions like Post-Traumatic Stress Disorder (PTSD), cognitive difficulties, or brain injuries. Sponsored by the Special Operations Care-Fund, this study will test four different treatments: hormone replacement, magnetic brain stimulation, ibogaine, and 5-Meo-DMT. The goal is to see how well these treatments work and how safe they are by observing changes in PTSD symptoms and cognitive abilities after the treatments.

To participate in this study, you need to be at least 18 years old and a veteran supported by the SOC-F Program. However, certain medical conditions could exclude you from participating, such as severe mental health disorders like schizophrenia or bipolar disorder, serious heart issues, or other significant health problems. If you join the study, you'll receive one of the four treatments and be monitored closely to assess how it affects your mental health and thinking abilities. The study is not currently recruiting participants, but it hopes to help improve the lives of veterans facing these challenges.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • At least 18 years of age
  • Sponsored by SOC-F Program
  • Exclusion Criteria:
  • Diagnosis of Schizophrenia, Bipolar I or II disorder for which patient has been hospitalized or medicated, Depersonalization and/or Derealization Disorder
  • Cerebellar dysfunction, Epilepsy, Psychosis or acute confusional state, Dementia
  • Prolonged corrected QT interval (QTc) Interval (450ms in males; 470ms in females)
  • History of heart failure or hypertrophic heart
  • Active blood clots (e.g., Pulmonary embolism, Deep vein thrombosis)
  • Major respiratory conditions (e.g., Emphysema, Cystic fibrosis)
  • Severe chronic gastrointestinal issues (e.g., bleeding ulcer, leaky gut syndrome)
  • Within 6 months of surgeries
  • Abnormal blood test results (e.g., potassium or magnesium outside normal range)
  • Impaired kidney or liver function
  • Refusal to taper off of selective serotonin reuptake inhibitor (SSRI) medication

About Johns Hopkins University

Johns Hopkins University, a prestigious research institution located in Baltimore, Maryland, is renowned for its commitment to advancing medical science and public health through innovative clinical trials. With a rich history of groundbreaking research and a multidisciplinary approach, the university's clinical trial initiatives focus on translating scientific discoveries into effective treatments and interventions. Leveraging state-of-the-art facilities and a collaborative network of experts, Johns Hopkins University conducts rigorous clinical studies that aim to improve patient outcomes and address critical health challenges. Its dedication to ethical standards and participant safety underscores its role as a leader in clinical research.

Locations

Baltimore, Maryland, United States

Patients applied

0 patients applied

Trial Officials

Sandeep Nayak, MD

Principal Investigator

Johns Hopkins University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported