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WithdrawnPhase 2

Trifecta Research Study

NCT06810765 · Johns Hopkins University

Closed to entry
Status
Not accepting participants
Phase 2
Phase
—
Target enrolment
1
Study sites
1 US states

What it is testing

Summary

The Special Operations Care-Fund (SOC-F) will sponsor the application of four treatments - hormone replacement, magnetic resonance brain stimulation, ibogaine, and 5-Meo-DMT - to Special Operations Forces veterans with a history of combat deployments, traumatic brain injury, and problems with mental health and cognitive functioning. An observational study will be conducted in parallel by the Johns Hopkins Center for Psychedelic and Consciousness Research to determine the effectiveness and safety of each treatment, primarily through measuring post-treatment changes in PTSD symptoms and cognitive functioning.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • PTSD Checklist for Diagnostic and Statistical Manual (DSM)-5 (PCL - 5)

    Measured over Up to 12 months follow up

  • Medical Outcomes Study Cognitive Functioning Scale (MOS-CF)

    Measured over UP to 12 months follow up

  • Externalized Free Recall with Emotional Words

    Measured over Up to 12 months follow up

  • Incidence of Adverse Events

    Measured over Up to 3-months follow-up

  • Depressive Symptom Index-Suicidality Subscale (DSI-SS)

    Measured over Up to 12 months follow up

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years
Ages
All
Sex
Not accepted
Healthy volunteers
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

Where

1 study site

FacilityCityRegionCountry
Johns Hopkins Center for Psychedelic and Consciousness ResearchBaltimoreMarylandUnited States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT06810765 on ClinicalTrials.gov →

Last updated in the registry 2025-08-22. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits

Substance

Recruiting in

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