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NCT07717866·Not applicable·OBSERVATIONAL

Trifecta Research Study

IpamorelinBrain healthActive, not recruiting

Status

Active, not recruiting

Phase

Not applicable

Enrollment

52

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full detailed description

Approximately forty participants took part in a program of experimental interventions and therapies that was created to improve psychological and cognitive health outcomes in a population with severe, treatment-resistant conditions. Participants were obtained from a cohort of SOF veterans who were already seeking these therapies through the Special Operations Care-Fund (SOC-F) and chose to volunteer for the study. Participants were assigned by SOC-F to one of two sequences of interventions through SOC-F's care providers. One group received PS, then MeRT, then IM and 5-MeO-DMT. The other group received PS, then IM and 5-MeO-DMT, then MeRT. PS preceded the other interventions in each condition. The study design includes self-report and informant-report questionnaires and cognitive task assessments, all of which monitor the interventions' impact on health outcomes. The general purpose is to explore the potential for this combination of treatments to improve mental health and cognitive function. A collection of subjective and objective data will allow a comprehensive assessment of therapeutic impact, with the ultimate goal of informing future clinical trials and veteran treatment services. This project was formerly registered on clinicaltrials.gov (NCT06810765). Aims and Hypotheses: Aim 1: Investigate the impact of all interventions on PTSD symptoms and cognitive function in SOF veterans with PTSD and cognitive difficulties. H1.1. Collectively, program interventions will be associated with reduced self-reported PTSD symptoms at 3-month follow-up (3MFU). H1.2. Collectively, program interventions will be associated with improved self-reported cognitive functioning at 3MFU. H1.3. Collectively, program interventions will be associated with improved cognitive inhibition, indexed by the Stroop Squared Task, at Post-treatment. H1.4. Collectively, program interventions will be associated with improved negative emotional memory, indexed by a higher proportion of recalled positive words (see V1.1 in Dependent Variable section) in the Externalizing Free Recall with Emotional Words Task, at Post-treatment. H1.5. Collectively, program interventions will be associated with improved positive emotional memory, indexed by a higher proportion of recalled positive words (V1.2) in the Externalizing Free Recall with Emotional Words Task, at Post-treatment. H1.6. Collectively, program interventions will be associated with improved negative emotional memory, indexed by a higher proportion of negative recall intrusions (V2.1) in the Externalizing Free Recall with Emotional Words Task, at Post-treatment. Aim 2: Investigate the incremental impact of IM and 5-Meo-DMT on PTSD symptoms and cognitive functioning relative to initial intervention with PS and MeRT in SOF veterans with PTSD and cognitive difficulties. H2.1. IM/5-Meo-DMT will be associated with an incremental reduction in self-reported PTSD symptoms at 3MFU, relative to the previous effects of PS and MeRT (measured at Pre-IM/5Meo timepoint). H2.2. IM/5-Meo-DMT will be associated with an incremental improvement in self-reported cognitive functioning at 3MFU, relative to the previous effects of PS and MeRT (measured at Pre-IM/5Meo timepoint). H2.3. IM/5-Meo-DMT will be associated with an incremental improvement in cognitive inhibition at Post-treatment, indexed by the Stroop Squared Task, relative to the previous effects of PS and MeRT (measured at Pre-IM/5Meo timepoint). Aim 3: Investigate whether the sequence of interventions differentially impacts PTSD and cognitive functioning at 3MFU in SOF veterans. No formal hypotheses. Aim 4: Investigate adverse events related to each of the interventions. No formal hypotheses.

Interventions

Treatment arms and agents.

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.

Timeline

From registration to results.

  1. First posted

    Jul 21, 2026

  2. Study start

    Aug 1, 2022

  3. Primary completion

    Feb 1, 2026

  4. Study completion

    Nov 2026

  5. Results posted

    Not reported

  6. Registry updated

    Jul 21, 2026

Outcomes

What the study measures.

Primary outcomes

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

Time frame · Up to 12 months follow up

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.

Medical Outcomes Study Cognitive Functioning Scale (MOS-CF)

Time frame · Up to 12 months follow up

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

Stroop Squared Task

Time frame · Up to 12 months follow-up

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.

Externalized Free Recall with Emotional Words Task

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

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.

Secondary outcomes

Depressive Symptom Index-Suicidality Subscale (DSI-SS)

Time frame · Up to 12 month follow-up

The DSI-SS assesses the severity of suicide ideation. The measure consists of 4 items, each with a Likert-type scale (0-4) indicating the frequency and severity of different aspects of suicidal ideation (e.g., planfulness, control, impulse). Higher scores indicate greater levels of suicidal ideation. 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.

Adverse Events

Time frame · Up to 3-month follow-up

Adverse event questions are administered at post-treatment and follow-up. Worsening suicidality (as indexed by the DSI-SS) following the first intervention will be logged as an adverse event.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
Yes

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 locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Axial Therapeutic Research

Northridge, California, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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