Microdosing + Meditation for Healthy Adults

(OMM Trial)

Overseen By Matthew Hicks, ND, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: National University of Natural Medicine

Must not be taking: Lithium, Antipsychotics, Phase II UGT

Disqualifiers: Schizophrenia, Psychosis, Heart disease, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the feasibility and safety of combining meditation with psilocybin microdosing (a psychedelic compound) for healthy adults. It examines how these treatments might impact sleep, heart health, and overall quality of life. Half of the participants will try psilocybin microdosing alone, while the other half will combine it with meditation. This trial suits individuals who are new to microdosing and have limited meditation experience. As an unphased trial, it provides a unique opportunity to explore new wellness practices in a controlled setting.

Will I have to stop taking my current medications?

If you are currently taking lithium, antipsychotics, or certain other medications, you may need to stop or taper off them, as they could interact with the study treatment. The study team will help determine if your medications pose a risk.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that psilocybin, the active ingredient in magic mushrooms, is under study for its safety in small amounts, known as microdosing. Previous studies have examined how psilocybin affects the mind and body. These studies suggest that healthy adults can use psilocybin safely when taken responsibly.

Some people have reported mild side effects, such as headaches and slight mood changes, but these effects usually don't last long and aren't serious. It's important to know that psilocybin is a hallucinogen, meaning it can alter perception and sensations. However, with microdosing, these effects are much milder.

Psilocybin is not yet approved by the FDA for medical use, but ongoing research explores its potential benefits and risks. Participation in clinical trials can help researchers learn more about its safe use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about microdosing psilocybin because it offers a novel approach to enhancing mental well-being. Unlike typical treatments that often involve pharmaceuticals targeting specific neurotransmitters, psilocybin is a naturally occurring psychedelic compound known for its potential to promote cognitive flexibility and emotional insight. The addition of meditation could further amplify these effects by fostering mindfulness and reducing stress. This combination might provide a more holistic and integrative way to improve mental health compared to traditional single-modality therapies.

What evidence suggests that this trial's treatments could be effective?

Research shows that psilocybin, a substance in certain mushrooms, can affect the mind and improve mood. Studies have found it may help reduce anxiety and lift mood in some situations. In this trial, participants will join different treatment arms. One arm involves microdosing psilocybin alone, while another combines small doses of psilocybin with meditation. Meditation helps people relax and reduce stress, and combining it with psilocybin might enhance these effects. Although data on very small doses is limited, early results suggest these doses might offer benefits without causing strong hallucinations. This trial examines how these combined methods might affect health indicators like sleep and heart rate. ^{1 2 3 4 5}

Who Is on the Research Team?

Matthew Hicks, ND, MS

Principal Investigator

National University of Natural Medicine

Are You a Good Fit for This Trial?

This trial is for healthy adults interested in combining meditation with psilocybin microdosing. Participants must be willing to use the Oura Ring to monitor biometrics and complete quality of life assessments. Details on specific inclusion or exclusion criteria are not provided.

Inclusion Criteria

I can attend all required study appointments.

I am 21 years old or older.

No more than 100 hours of lifetime meditation experience

Exclusion Criteria

Any form of personality disorder

I am not taking lithium, antipsychotics, diclofenac, probenecid, or similar drugs that could interact with the study treatment.

I have uncontrolled high blood pressure or heart disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Wash-in Period

Participants undergo a one-week wash-in period before the primary intervention

1 week

Treatment

Participants receive psilocybin microdosing, with half also receiving meditation intervention

2 weeks

2 microdosing sessions per week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Meditation
• Psilocybin

Trial Overview The study tests if it's feasible to combine meditation with psilocybin microdosing. All participants will try microdoses of psilocybin, but only half, chosen randomly, will also practice meditation. The trial measures recruitment success, participant retention, safety, tolerability, and various health outcomes.

How Is the Trial Designed?

Group I: Microdosing plus meditation Experimental Treatment 2 Interventions

Group II: Microdosing only Experimental Treatment 1 Intervention

Psilocybin is already approved in United States, European Union for the following indications:

Approved in United States as Psilocybin for:

• Treatment-resistant depression (TRD) under Breakthrough Therapy designation

Approved in European Union as Psilocybin for:

• Treatment-resistant depression (TRD) under PRIME designation

Who Is Running the Clinical Trial?

National University of Natural Medicine

Lead Sponsor

Trials

34

Recruited

1,400+

Published Research Related to This Trial

A new liquid chromatography-tandem mass spectrometry (LC-MS/MS) method was developed to quickly and accurately measure the levels of psilocybin and psilocin in magic truffles, with high precision and reliability (r² > 0.99).

The study found that only psilocybin was present in the examined Psilocybe sclerotia, with concentrations ranging from 59.3 to 167.8 µg per 100 mg of fresh truffles, indicating variability in psilocybin content.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magic truffles or Philosopher's stones: a legal way to sell psilocybin? Pellegrini, M., Rotolo, MC., Marchei, E., et al.[2019]

A 30-year-old man experienced severe symptoms, including vomiting and muscle pain, after receiving an intravenous injection of Psilocybe mushroom extract, highlighting the potential dangers of using hallucinogenic substances in non-traditional ways.

The patient showed rapid improvement with supportive care, suggesting that while the effects of Psilocybe mushrooms can be serious, timely medical intervention can effectively manage the symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous mushroom poisoning. Curry, SC., Rose, MC.[2019]

In a survey of 1993 individuals who experienced challenging psilocybin trips, 39% rated their experience as one of the most difficult of their lives, with 11% reporting risks of physical harm, particularly influenced by dose and lack of support.

Despite the challenges, 84% of respondents felt they benefited from the experience, suggesting that while adverse effects can occur, the overall incidence of serious psychological distress is low, especially in controlled settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survey study of challenging experiences after ingesting psilocybin mushrooms: Acute and enduring positive and negative consequences. Carbonaro, TM., Bradstreet, MP., Barrett, FS., et al.[2018]

Psilocybin, a serotonergic psychedelic, has shown promise in treating various psychiatric disorders, including depression and substance use disorders, with 9 clinical trials conducted between 2000 and 2020.

The treatment is generally well tolerated with limited side effects, and some patients with treatment-resistant conditions have experienced significant long-term improvements after just a few sessions, indicating its potential efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment with psilocybin: applications for patients with psychiatric disorders]. Breeksema, JJ., Koolen, MHB., Somers, M., et al.[2021]

Psilocybin shows promising effects in alleviating anxiety, depression, and emotional distress in palliative care patients, with a favorable safety profile, based on recent studies and reports.

Despite its potential benefits, psilocybin is not yet approved for therapeutic use in the U.S., and significant barriers exist for access, particularly for vulnerable populations like the elderly and those in palliative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psilocybin in Palliative Care: An Update. Whinkin, E., Opalka, M., Watters, C., et al.[2023]

In a study of 27 patients with moderate to severe major depressive disorder, psilocybin-assisted treatment showed significant and lasting antidepressant effects, with 75% of participants experiencing a treatment response and 58% achieving remission after 12 months.

There were no serious adverse events related to psilocybin, indicating a favorable safety profile, and participants reported meaningful personal and spiritual experiences that correlated with increased well-being, although these did not directly predict improvements in depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of psilocybin-assisted treatment for major depressive disorder: Prospective 12-month follow-up. Gukasyan, N., Davis, AK., Barrett, FS., et al.[2022]

In a study involving eight volunteers, psilocybin was administered, and its metabolite, psilocin, was found to peak in urine concentrations up to 870 microg/L within 2-4 hours after ingestion, indicating a rapid metabolism.

About 3.4% of the psilocybin dose was excreted as free psilocin within 24 hours, and using beta-glucuronidase to treat urine samples significantly increased detectable levels of psilocin, suggesting that enzymatic processes can enhance the detection of this metabolite.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Renal excretion profiles of psilocin following oral administration of psilocybin: a controlled study in man. Hasler, F., Bourquin, D., Brenneisen, R., et al.[2019]

Psilocybin, a hallucinogenic compound found in certain mushrooms, has been associated with increasing rates of drug abuse, highlighting the need for comprehensive pharmacological understanding.

Despite its historical use in the 1960s for experimental medical purposes, recent research has only begun to uncover the pharmacological properties of psilocybin, indicating a gap in knowledge that needs to be addressed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The pharmacology of psilocybin. Passie, T., Seifert, J., Schneider, U., et al.[2016]

In a study examining the effects of Psilocybe cubensis and Panaeolus cyanescens mushrooms on heart cells, the extracts did not worsen hypertrophy caused by endothelin-1 and provided protection against TNF-α-induced cell injury.

The findings suggest that these mushroom extracts can be safely used in controlled conditions for potential therapeutic benefits in heart disease, although caution is advised with higher concentrations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects and safety of Psilocybe cubensis and Panaeolus cyanescens magic mushroom extracts on endothelin-1-induced hypertrophy and cell injury in cardiomyocytes. Nkadimeng, SM., Steinmann, CML., Eloff, JN.[2021]

Psilocybin-containing mushrooms, commonly known as hallucinogenic or 'magic' mushrooms, rapidly affect the central nervous system within 0.5-1 hour of ingestion, leading to effects such as ataxia, hyperkinesis, and hallucinations.

The review discusses the significant toxicity associated with these mushrooms, highlighting the need for awareness and understanding of their pharmacology, clinical effects, and potential treatment for adverse reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Hallucinogenic mushrooms]. Reingardiene, D., Vilcinskaite, J., Lazauskas, R.[2018]

The study successfully utilized GLC-mass spectrometry to analyze psilocin and psilocybin, two hallucinogenic compounds, by converting them into trimethylsilyl derivatives for better detection.

This method was specifically applied to an extract of the Psilocybe cubensis mushroom, indicating its potential for accurately identifying and quantifying these psychoactive substances in natural samples.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

GLC-mass spectral analysis of psilocin and psilocybin. Repke, DB., Leslie, DT., Mandell, DM., et al.[2019]

Citations

1. en.wikipedia.org en.wikipedia.org/wiki/Psilocybin

Psilocybin Psilocybin, also known as 4-phosphoryloxy-N,N-dimethyltryptamine (4-PO-DMT), is a naturally occurring tryptamine alkaloid and investigational drug found in ...

2. pubchem.ncbi.nlm.nih.gov pubchem.ncbi.nlm.nih.gov/compound/Psilocybin

Psilocybin | C12H17N2O4P | CID 10624 - PubChem - NIH Psilocybin is a tryptamine alkaloid that is N,N-dimethyltryptamine carrying an additional phosphoryloxy substituent at position 4.

3. webbook.nist.gov webbook.nist.gov/cgi/cbook.cgi?ID=520-52-5

Psilocybine - the NIST WebBook Psilocybine. Formula: C12H17N2O4P ... 4-Phosphoryloxy-N,N-dimethyltryptamine; Psilocibin; Psilocin phosphate ester; Psilotsibin; Teonanacatl; Psylocybin ...

4. zfin.org zfin.org/CHEBI:8614

ZFIN ChEBI: psilocybin A tryptamine alkaloid that is N,N-dimethyltryptamine carrying an additional phosphoryloxy substituent at position 4. The major hallucinogenic alkaloid isolated ...

5. cancer.gov cancer.gov/publications/dictionaries/cancer-drug/def/psilocybine

Definition of psilocybine - NCI Drug Dictionary A tryptamine alkaloid, isolated from various genera of fungi including the genus Psilocybe, with hallucinogenic, anxiolytic, and psychoactive activities.