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.
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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A previous registration of this study was withdrawn.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
Dosing
Integration
Therapeutic Protocol
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)
- Ibogainevia Oral• orally
- 5-MeO-DMTvia 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)
- Ibogainevia Oral• orally
- 5-MeO-DMTvia Inhalation
- Compound
Unmatched intervention: Physiological Supplementation
Participants
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
- StatusActive not recruiting
- PhasePhase NA
- Typeobservational
- DesignNon-randomized
- Target Enrollment52 participants
- TimelineStart: 2022-08-01End: 2026-11-01
- Compounds
- Topic
Locations
Recent activity
- StartedTrifecta Research Study (Axial) (NCT07717866, ibogaine)
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