Clinical TrialSingle-armMajor Depressive Disorder (MDD)Ibogaine5-MeO-DMTActive not recruiting

Trifecta Research Study (Axial)

This observational study (n=52) will assess the impact of ibogaine-magnesium, 5-MeO-DMT, magnetic e-Resonance Therapy (MeRT), and physiological supplementation on post-traumatic stress disorder (PTSD), cognitive dysfunction, brain injury-related symptoms, depression, and suicidal ideation in Special Operations Forces combat veterans. It will examine whether these interventions, delivered in different sequences, are associated with improvements in PTSD symptoms and cognitive functioning over follow-up. Participants were assigned to one of two intervention sequences: physiological supplementation followed by MeRT and then ibogaine with magnesium and 5-MeO-DMT, or physiological supplementation followed by ibogaine with magnesium and 5-MeO-DMT and then MeRT. Ibogaine hydrochloride was given orally, with magnesium sulfate administered intravenously before ibogaine and orally each day; 5-MeO-DMT was inhaled as vapour using a pipe. Physiological supplementation could include synthetic testosterone, anastrozole, gonadorelin, vitamin and amino acid supplementation, fish oil, and ipamorelin. Outcomes included the PCL-5, Medical Outcomes Study Cognitive Functioning Scale, Stroop Squared Task, and an emotional free-recall task, with assessments reported up to 12 months and up to 15 weeks for the recall measure.

Target Enrollment
52 participants
Study Type
Phase NA observational
Design
Non-randomized

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Detailed Description

This observational study evaluates the impact of Ibogaine-Magnesium (IM), 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT), Magnetic e-Resonance Therapy (MeRT), and Physiological Supplementation (PS) on posttraumatic stress disorder (PTSD) and traumatic brain injury-related cognitive symptoms among Special Operations Forces (SOF) combat veterans.

A previous registration of this study was withdrawn.

Study Protocol

Preparation

sessions

Dosing

sessions

Integration

sessions

Therapeutic Protocol

unknown

Study Arms & Interventions

Physiological supplementation, then ibogaine/5-MeO-DMT, then MeRT

Individuals in this arm will undergo Physiological Supplementation, then Ibogaine and 5-MeO treatment, and then MeRT therapy.

Interventions

  • Compound

    Unmatched intervention: Magnetic e-Resonance Therapy (MeRT)

  • Ibogaine
    via Oralorally
  • 5-MeO-DMT
    via Inhalation
  • Compound

    Unmatched intervention: Physiological Supplementation

Physiological supplementation, then MeRT, then ibogaine/5-MeO-DMT

Individuals in this arm will undergo Physiological Supplementation, then MeRT therapy, and then Ibogaine and 5-MeO-DMT.

Interventions

  • Compound

    Unmatched intervention: Magnetic e-Resonance Therapy (MeRT)

  • Ibogaine
    via Oralorally
  • 5-MeO-DMT
    via Inhalation
  • Compound

    Unmatched intervention: Physiological Supplementation

Participants

Ages
18?
Sexes
Male & Female

Inclusion Criteria

  • At least 18 years of age
  • Sponsored by SOC-F Program

Exclusion Criteria

  • (evaluated by SOC-F, not Axial Therapeutic Research):
  • 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 Protocol, Arms & Participants

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Study Details

Locations

Axial Therapeutic ResearchNorthridge, California, United States

Recent activity

  • StartedTrifecta Research Study (Axial) (NCT07717866, ibogaine)

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