Trifecta Research Study

NCT07717866 | Active Not Recruiting FDA Device

• 1 other identifier: 65357
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

PTSD - Post Traumatic Stress Disorder; Cognitive Dysfunction; Brain Injury; Depression - Major Depressive Disorder; Suicidal Ideation

Keywords

ibogaine; psychedelic; MeRT; special operations; veteran; PTSD; depression; TBI; TMS; suicidal ideation; suicidality

Outcome Measures

Primary Outcomes (4)

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

  The PTSD Checklist for DSM-5 (PCL-5) is a self-report questionnaire designed to assess the severity of PTSD symptoms in alignment with the DSM-5 diagnostic criteria. A total symptom severity score (range - 0-80) will be obtained by summing the scores for each of the 20 items with higher scores indicating greater symptom severity. Data Collected: Group/Sequence A: Baseline, pre-PS, pre-IM/5Meo, pre-MeRT, mid-MeRT, Post-MeRT, 3 MFU, 6 MFU, 12 MFU; - Group/Sequence B: Baseline, pre-PS, pre-MeRT, mid-MeRT (week 3 MeRT), pre-IM/5Meo, post-IM/5Meo, 3 month follow up (MFU), 6MFU, 12MFU.

  Up to 12 months follow up

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

  The Medical Outcomes Study - Cognitive Functioning (MOS-CF) self-report scale consists of 6 items that are designed to measure perceived cognitive functioning. Each item is scored on a 6-point scale (1-6), with 1 being 'all of the time' and 6 being 'none of the time.' Higher scores indicate higher cognitive functioning and lower cognitive symptoms. Collected - Group/Sequence 1: Baseline, pre-HRT, pre-MeRT, mid-MeRT (week 3 MeRT), pre-Ibo/5Meo, post-Ibo/5Meo, 3 month follow up (MFU), 6 MFU, 12 MFU; Group/Sequence 2: Baseline, pre-HRT, pre-Ibo/5Meo, pre-MeRT, mid-MeRT, Post-MeRT, 3 MFU, 6 MFU, 12 MFU

  Up to 12 months follow up

• Stroop Squared Task

  In the Stroop Squared Task, participants will select words corresponding to the color of the stimulus word given. For example, participants will name the color of the ink a word is printed in while ignoring the word itself (e.g., the word "BLUE" printed in red ink). The task primarily measures cognitive inhibition. Each participant will receive one score indexing the delay in reaction time caused by the mismatch between word and color. Data Collected: Group/Sequence A: Baseline, pre-PS, pre-IM/5Meo, pre-MeRT, mid-MeRT, Post-MeRT, 3 MFU, 6 MFU, 12 MFU; - Group/Sequence B: Baseline, pre-PS, pre-MeRT, mid-MeRT (week 3 MeRT), pre-IM/5Meo, post-IM/5Meo, 3MFU, 6MFU, 12MFU.

  Up to 12 months follow-up

• Externalized Free Recall with Emotional Words Task

  In the Externalized Free Recall with Emotional Words Task, participants will be presented with a series of emotionally positive, negative, and neutral stimuli (e.g., words or images) and asked to recall the stimuli. The task captures how well individuals retain and recall emotional versus neutral content. Dependent variables include: V1. The proportion of total words correctly recalled of total words administered V1.1. The proportion of recalled negative words of all words recalled V1.2. The proportion of recalled positive words of all words recalled V1.3. The proportion of recalled neutral words of all words recalled V2. The absolute number of total recall intrusions V2.1. The proportion of intruding negative words of all intruding words V2.2. The proportion of intruding positive words of all intruding words V2.3. The proportion of intruding neutral words of all intruding words Data Collected: Group/Sequence A: pre-PS, Post-MeRT; Group/Sequence B: pre-PS, post-IM/5Meo.

  Up to 15 weeks (Post-MeRT for Group A, Post-IM/5MeO for Group B)

Secondary Outcomes (2)

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

  Up to 12 month follow-up

• Adverse Events

  Up to 3-month follow-up

Study Arms (2)

Intervention Sequence 1

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

Device: Magnetic e-Resonance Therapy (MeRT); Drug: Ibogaine Hydrochloride with Magnesium Sulfate; Drug: 5-methoxy-N,N-dimethyltryptamine; Drug: Physiological Supplementation

Intervention Sequence 2

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

Device: Magnetic e-Resonance Therapy (MeRT); Drug: Ibogaine Hydrochloride with Magnesium Sulfate; Drug: 5-methoxy-N,N-dimethyltryptamine; Drug: Physiological Supplementation

Interventions

5-methoxy-N,N-dimethyltryptamine DRUG

5-MeO-DMT is administered by using a pipe to inhale a vapor that is produced by heating a canister containing a powder form of the substance. 5-MeO-DMT is a 5-HT-1A and 5-HT-2A agonist compound that has shown early signs of effectiveness in treating depression. Inhaled 5-MeO-DMT has a short duration of action, producing an intense, time-limited psychoactive state.

Intervention Sequence 1; Intervention Sequence 2

Physiological Supplementation DRUG

Physiological Supplementation describes a treatment program aimed at restoring healthy endocrine functioning, using supplements such as the following: Synthetic testosterone, Anastrozole, Gonadorelin, Vitamin and amino acid supplementation, Fish oil, Ipamorelin.

Intervention Sequence 1; Intervention Sequence 2

Magnetic e-Resonance Therapy (MeRT) DEVICE

MeRT, an electroencephalography (EEG)-guided Repetitive Transcranial Magnetic Stimulation therapy, is a non-invasive treatment that uses magnetic pulses to modulate neural networks of the brain, guided by an individual's brain patterns. MeRT is a neuromodulatory tool that has shown therapeutic efficacy in relation to decreasing severity of PTSD symptoms. There is preliminary data showing MeRT's therapeutic impact on depression and TBI-related cognitive impairment through promoting cortical excitability, modulating neurotransmission, and restoring neuroplasticity.

Intervention Sequence 1; Intervention Sequence 2

Ibogaine Hydrochloride with Magnesium Sulfate DRUG

Ibogaine hydrochloride was administered orally. Ibogaine is an indole alkaloid that together with its metabolites interacts with mu opioid, kappa opioid, N-methyl-D-aspartate receptor (NMDA), and nicotinic acetylcholine receptors. Ibogaine has shown early signs of effectiveness as a rapid-acting treatment for a number of mental health disorders including PTSD and substance use disorder. Magnesium sulfate was administered intravenously prior to Ibogaine administration and orally each day.

Intervention Sequence 1; Intervention Sequence 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants were obtained from a cohort of treatment-seeking SOF veterans with problems in mental health including PTSD, cognitive symptoms related to traumatic brain injury, depression, and suicidality. Participants were selected and sponsored by SOC-F.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Axial Therapeutic Research: lead

Study Sites (1)

Axial Therapeutic Research

Northridge, California, 91325, United States

Location

MeSH Terms

Conditions

Combat Disorders; Cognitive Dysfunction; Brain Injuries; Suicidal Ideation; Stress Disorders, Post-Traumatic; Depression

Interventions

Magnesium Sulfate; Methoxydimethyltryptamines

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Cognition Disorders; Neurocognitive Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; N,N-Dimethyltryptamine; Tryptamines; Biogenic Monoamines; Biogenic Amines; Amines; Organic Chemicals; Bufotenin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Serotonin

Study Officials

• I S Kroop

  Axial Therapeutic Research

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 21, 2026
• Study Start: August 1, 2022
• Primary Completion: February 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: July 21, 2026

Record last verified: 2026-07

Locations

US (1)