Psilocybin + Mindfulness for Mental Health

(MAPT Trial)

Overseen By Mary Falcone, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Southern California

Must not be taking: Antidepressants, Antipsychotics, MAOIs, others

Disqualifiers: Schizophrenia, Bipolar, Drug dependence, 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: 12

Duration: 8 weeks

40 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

Yes, you may need to stop taking certain medications. The trial excludes participants who are currently using specific medications like antidepressants, antipsychotics, and others that affect the serotonin system. If you use these medications intermittently, there must be a gap of at least 5 half-lives of the medication before participating in a psilocybin session.

What data supports the effectiveness of the treatment Mindfulness-assisted Psychedelic Therapy for mental health?

Research suggests that combining psilocybin (a psychedelic drug) with mindfulness practices can enhance mood, increase mindfulness, and improve social skills. Studies show that psilocybin can lead to long-term positive changes in personality and psychological functioning, especially when combined with meditation or spiritual practices. ^{1 2 3 4 5}

Is psilocybin combined with mindfulness safe for mental health treatment?

Psilocybin, when used in a controlled and supportive environment, is generally considered safe, with most people finding the experience positive. Some may experience challenging moments, but these are usually manageable with support. Psilocybin can cause temporary increases in blood pressure, but no long-term negative effects have been reported in well-prepared participants. ^{4 6 7 8 9}

How is Mindfulness-assisted Psychedelic Therapy different from other treatments for mental health?

Mindfulness-assisted Psychedelic Therapy combines mindfulness meditation with psilocybin, a psychedelic, to potentially enhance the therapeutic effects of both. This unique combination may improve mental health by altering present-moment awareness and providing antidepressant effects, which are not typically achieved with standard treatments. ^{1 10 11 12 13}

What is the purpose of this trial?

The goal of this clinical trial is to test psilocybin in combination with mindfulness training in healthy adults. The main question it aims to answer is "Does mindfulness training enhance the effects of psychedelic therapy (psilocybin) on mental health?" Interested individuals will complete an initial eligibility session and eligible participants will then be randomized into one of two groups: one dose of psilocybin (administered under the supervision of study therapists) combined with 8 weeks of weekly mindfulness training classes (Arm 1) or psilocybin alone (Arm 2). Both groups will complete baseline and post-treatment assessment sessions where they will complete questionnaires and have an EEG (a measure of electrical activity in the brain). Both groups will also complete 2 follow-up surveys (at 8 weeks and 1 year after the post-treatment assessment) either online through REDCap or by phone or video call with a research assistant.

Research Team

Baruch R Cahn, MD, PhD

Principal Investigator

University of Southern California

Eligibility Criteria

This trial is for healthy adults interested in exploring the effects of psychedelic therapy on mental health. Participants must be eligible based on an initial session and willing to undergo psilocybin treatment under supervision, with or without mindfulness training. Details about specific inclusion and exclusion criteria are not provided.

Inclusion Criteria

Agree to consume approximately the same amount of caffeine-containing beverage (e.g., coffee, tea) that he/she consumes on a usual morning, before arriving at the research unit on the morning of the drug session day. If the participant does not routinely consume caffeinated beverages, he/she must agree not to do so on the session day.

I agree not to take any as-needed medications on the mornings of drug sessions.

I agree not to take ED medications like Viagra 72 hours before taking psilocybin.

Exclusion Criteria

Current pregnancy, planned pregnancy in the next 6 months, positive urine pregnancy test, or current breastfeeding

Self-reported use of or positive urine drug screen for specific substances

I take prescription medication for my mental health daily.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive one dose of psilocybin, with Arm 1 also receiving 8 weeks of mindfulness training

8 weeks

8 visits (in-person for mindfulness training), 1 visit (in-person for psilocybin administration)

Post-treatment Assessment

Participants complete questionnaires and cognitive assessments, including EEG

1 week

1 visit (in-person)

Follow-up

Participants complete follow-up surveys at 8 weeks and 1 year after post-treatment assessment

1 year

2 visits (virtual or phone)

Treatment Details

Interventions

• Mindfulness-assisted Psychedelic Therapy

Trial Overview The study tests if mindfulness training can boost the benefits of psilocybin, a psychedelic drug, for mental health. Participants will either receive psilocybin with 8 weeks of mindfulness classes (Arm 1) or just psilocybin (Arm 2), followed by assessments including questionnaires and EEGs.

Participant Groups

Group I: Mindfulness-assisted psilocybin therapy Experimental Treatment 1 Intervention

8 weeks of mindfulness training plus one 25mg dose of psilocybin

Group II: Psilocybin only Active Control 1 Intervention

One 25mg dose of psilocybin

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

Findings from Research

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Depression, Mindfulness, and Psilocybin: Possible Complementary Effects of Mindfulness Meditation and Psilocybin in the Treatment of Depression. A Review. [2023]

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

A single psilocybin dose is associated with long-term increased mindfulness, preceded by a proportional change in neocortical 5-HT2A receptor binding. [2021]

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

Characterization and prediction of acute and sustained response to psychedelic psilocybin in a mindfulness group retreat. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Lasting increases in trait mindfulness after psilocybin correlate positively with the mystical-type experience in healthy individuals. [2022]

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

Psilocybin-occasioned mystical-type experience in combination with meditation and other spiritual practices produces enduring positive changes in psychological functioning and in trait measures of prosocial attitudes and behaviors. [2019]

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

Psilocybin-Assisted Therapy: A Review of a Novel Treatment for Psychiatric Disorders. [2018]

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

Survey study of challenging experiences after ingesting psilocybin mushrooms: Acute and enduring positive and negative consequences. [2018]

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

Acute, subacute and long-term subjective effects of psilocybin in healthy humans: a pooled analysis of experimental studies. [2016]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Trajectory of Antidepressant Effects after Single- or Two-Dose Administration of Psilocybin: A Systematic Review and Multivariate Meta-Analysis. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Examining the Potential Synergistic Effects Between Mindfulness Training and Psychedelic-Assisted Therapy. [2021]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Mindfulness meditation and psychedelics: potential synergies and commonalities. [2023]

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

Combining Psychedelic and Mindfulness Interventions: Synergies to Inform Clinical Practice. [2022]

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

Meditation trips: A thematic analysis of the combined naturalistic use of psychedelics with meditation practices. [2023]