Trifecta Research Study

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

Interventions

DEVICE

Magnetic e-Resonance Therapy (MeRT)

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.

DRUG

Ibogaine Hydrochloride with Magnesium Sulfate

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.

DRUG

5-methoxy-N,N-dimethyltryptamine

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.

DRUG

Physiological Supplementation

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.

Sponsors & Collaborators

• Axial Therapeutic Research

  lead INDUSTRY

Principal Investigators

• I S Kroop · Axial Therapeutic Research

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-08-01

Primary Completion

2026-02-01

Completion

2026-11-30

FDA Device

Yes

Countries

• United States

Study Locations