Clinical TrialPTSDIbogaine5-MeO-DMTIbogaine5-MeO-DMTWithdrawn

Trifecta Research Study

Non-randomised, parallel interventional study (n=40) testing sequences of HRT, MeRT, ibogaine and 5‑MeO‑DMT in Special Operations Forces veterans with PTSD and cognitive difficulties following TBI.

Target Enrollment
40 participants
Study Type
Phase II interventional
Design
Non-randomized

Detailed Description

This interventional programme enrolls 40 SOF veterans with combat deployments, PTSD and cognitive symptoms related to TBI to evaluate sequences of Hormone Replacement Therapy, Magnetic e‑resonance Therapy (MeRT), ibogaine and 5‑MeO‑DMT.

Participants are assigned to one of two parallel sequences delivered by SOC‑F contracted providers; outcomes include changes in PTSD symptoms, cognitive function, objective cognitive tasks and safety/adverse events up to 3‑month follow‑up.

An observational study will run in parallel by the Johns Hopkins Center for Psychedelic and Consciousness Research to further evaluate effectiveness and safety signals.

Study Protocol

Preparation

sessions

Dosing

sessions

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

Sequence A

experimental

HRT → Ibogaine + 5‑MeO‑DMT → MeRT sequence delivered by SOC‑F contracted providers.

Interventions

  • Compound
    via Other• multiple sessions

    Hormone Replacement Therapy (HRT) as clinically indicated.

  • Compound
    via Other• multiple sessions

    Magnetic e‑resonance therapy (MeRT), EEG‑guided rTMS modality.

  • Ibogaine
    via Other• single or limited dosing sessions

    Ibogaine with magnesium treatment; dosing per protocol (not specified in registry fragment).

  • 5-MeO-DMT
    via Other• single or limited dosing sessions

    5‑MeO‑DMT administered per protocol (dose not specified).

Sequence B

active comparator

HRT → MeRT → Ibogaine + 5‑MeO‑DMT sequence delivered by SOC‑F contracted providers.

Interventions

  • Compound
    via Other• multiple sessions

    Hormone Replacement Therapy (HRT) as clinically indicated.

  • Compound
    via Other• multiple sessions

    Magnetic e‑resonance therapy (MeRT), EEG‑guided rTMS modality.

  • Ibogaine
    via Other• single or limited dosing sessions

    Ibogaine with magnesium treatment; dosing per protocol (not specified).

  • 5-MeO-DMT
    via Other• single or limited dosing sessions

    5‑MeO‑DMT administered per protocol (dose not specified).

Participants

Ages
18 – 99
Sexes
Male & Female

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

Study Details

  • Status
    Withdrawn
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment40 participants
  • Timeline
    Start: 2025-03-01
    End: 2027-03-01
  • Compounds
    Ibogaine5-MeO-DMTIbogaine5-MeO-DMT
  • Topic
    PTSD

Locations

Johns Hopkins Center for Psychedelic and Consciousness Research — Baltimore, Maryland, United States

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