Multiple Treatments for Brain Injury

Overseen By Sandeep M Nayak, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Johns Hopkins University

Must not be taking: SSRIs

Disqualifiers: Schizophrenia, Bipolar, Epilepsy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

40 Participants Needed

Trial Summary

What is the purpose of this trial?

The Special Operations Care-Fund (SOC-F) will sponsor the application of four treatments - hormone replacement, magnetic resonance brain stimulation, ibogaine, and 5-Meo-DMT - to Special Operations Forces veterans with a history of combat deployments, traumatic brain injury, and problems with mental health and cognitive functioning. An observational study will be conducted in parallel by the Johns Hopkins Center for Psychedelic and Consciousness Research to determine the effectiveness and safety of each treatment, primarily through measuring post-treatment changes in PTSD symptoms and cognitive functioning.

Will I have to stop taking my current medications?

The trial requires participants to stop taking selective serotonin reuptake inhibitor (SSRI) medications. If you are on SSRIs, you must be willing to taper off them to join the study.

What data supports the effectiveness of the drug 5-MeO-DMT for brain injury?

Research shows that 5-MeO-DMT, when used with ibogaine, has helped improve mental health issues like PTSD, depression, and anxiety in veterans, and has shown potential in treating alcohol use disorder. These findings suggest it might have benefits for brain injury recovery as well. ^{1 2 3 4 5}

Is hormone replacement therapy (HRT) generally safe for humans?

HRT can help with menopause symptoms and protect against some conditions, but it may increase the risk of heart disease, breast cancer, and stroke. The safety of HRT depends on individual factors, and it should be carefully considered with a healthcare provider. ^{6 7 8 9 10}

How does the treatment for brain injury using 5-MeO-DMT, HRT, ibogaine with magnesium, and MeRT differ from other treatments?

This treatment is unique because it combines psychedelic substances like 5-MeO-DMT and ibogaine, which may promote brain healing through neuroplasticity (the brain's ability to reorganize itself) and neurogenesis (the growth of new brain cells), with hormone replacement and magnetic resonance therapy, offering a multi-faceted approach to address the complex nature of brain injuries. ^{11 12 13 14 15}

Research Team

Sandeep Nayak, MD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

This trial is for Special Operations Forces veterans aged 18 or older with a history of combat deployments and brain injuries, who are experiencing mental health and cognitive issues. It's not open to those with severe psychiatric disorders, major organ dysfunction, recent surgeries, abnormal blood tests, or unwillingness to stop taking SSRI medications.

Inclusion Criteria

Sponsored by SOC-F Program

I am 18 years old or older.

Exclusion Criteria

I refuse to stop taking my SSRI medication.

Prolonged corrected QT interval (QTc) Interval (450ms in males; 470ms in females)

I have a major lung condition like emphysema or cystic fibrosis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a sequence of treatments including Hormone Replacement Therapy, Magnetic e-Resonance Therapy, Ibogaine, and 5-MeO-DMT

12 weeks

Multiple visits for each treatment phase

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

3-month, 6-month, and 12-month follow-up visits

Treatment Details

Interventions

• 5-MeO-DMT
• Hormone Replacement Therapy (HRT)
• ibogaine with magnesium treatment
• Magnetic Resonance Therapy (MeRT)

Trial Overview The Trifecta Research Study is testing the effects of hormone replacement therapy (HRT), magnetic resonance therapy (MeRT), ibogaine with magnesium treatment, and 5-MeO-DMT on veterans' PTSD symptoms and cognitive function. Johns Hopkins will observe outcomes without altering participants' normal routines.

Participant Groups

Group I: Individuals in this arm will undergo HRT, then Ibogaine and 5-MeO treatment, and then MeRT therapy. Experimental Treatment 4 Interventions

Group II: Individuals in this arm will undergo HRT, then MeRT therapy, and then Ibogaine and 5-MeO-DMT. Active Control 4 Interventions

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Special Operators Care Fund

Collaborator

Trials

1

Recruited

40+

Findings from Research

In a survey of 362 participants who used 5-MeO-DMT in a structured group setting, 80% of those with depression and 79% with anxiety reported improvements in their conditions after use, suggesting potential therapeutic effects.

The improvements in depression and anxiety were linked to the intensity of mystical experiences and the perceived spiritual significance of the 5-MeO-DMT experience, rather than the challenging effects during the experience, indicating a unique mechanism of action that warrants further clinical investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) used in a naturalistic group setting is associated with unintended improvements in depression and anxiety. Davis, AK., So, S., Lancelotta, R., et al.[2020]

The psychedelic drug 5-MeO-DMT (GH001) was well tolerated in a study of 16 adults with treatment-resistant depression (TRD), showing significant safety in its administration.

In the Phase 2 trial, an individualized dosing regimen led to an impressive 87.5% remission rate by day 7, demonstrating potent and ultra-rapid antidepressant effects compared to lower remission rates in the single-dose groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase 1/2 trial to assess safety and efficacy of a vaporized 5-methoxy-N,N-dimethyltryptamine formulation (GH001) in patients with treatment-resistant depression. Reckweg, JT., van Leeuwen, CJ., Henquet, C., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Open-label study of consecutive ibogaine and 5-MeO-DMT assisted-therapy for trauma-exposed male Special Operations Forces Veterans: prospective data from a clinical program in Mexico. [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

A case report SPECT study and theoretical rationale for the sequential administration of ibogaine and 5-MeO-DMT in the treatment of alcohol use disorder. [2019]

3. England pubmed.ncbi.nlm.nih.gov

N,N-dimethyltryptamine and Amazonian ayahuasca plant medicine. [2023]

4. England pubmed.ncbi.nlm.nih.gov

5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) used in a naturalistic group setting is associated with unintended improvements in depression and anxiety. [2020]

5. Switzerland pubmed.ncbi.nlm.nih.gov

A phase 1/2 trial to assess safety and efficacy of a vaporized 5-methoxy-N,N-dimethyltryptamine formulation (GH001) in patients with treatment-resistant depression. [2023]

6. Germany pubmed.ncbi.nlm.nih.gov

[After disappointment regarding secondary cardiac prevention. What is the status of hormone replacement therapy today?]. [2007]

7. Australia pubmed.ncbi.nlm.nih.gov

Evidence-based review of therapies at the menopause. [2011]

8. England pubmed.ncbi.nlm.nih.gov

Are pharmacological considerations of relevance in hormone replacement therapy for prevention of chronic disease? [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Do soy isoflavones cause endometrial hyperplasia? [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Selective modulation of postmenopausal women: cutting the Gordian knot of hormone replacement therapy with breast carcinoma. [2005]

11. New Zealand pubmed.ncbi.nlm.nih.gov

Melatonin as a Potential Regulator of Oxidative Stress, and Neuroinflammation: Mechanisms and Implications for the Management of Brain Injury-Induced Neurodegeneration. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Therapeutic potential of melatonin in traumatic central nervous system injury. [2021]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Psychedelics for Brain Injury: A Mini-Review. [2021]

14. Netherlands pubmed.ncbi.nlm.nih.gov

Vitamins and nutrients as primary treatments in experimental brain injury: Clinical implications for nutraceutical therapies. [2018]

15. Switzerland pubmed.ncbi.nlm.nih.gov

Herbal Medicine for Traumatic Brain Injury: A Systematic Review and Meta-Analysis of Randomized Controlled Trials and Limitations. [2020]