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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether combining psilocybin (a psychedelic) with mindfulness training can improve mental health. Participants will be divided into two groups: one will receive psilocybin with mindfulness classes, and the other will receive psilocybin alone. The researchers aim to determine if mindfulness enhances the effects of psilocybin therapy. Ideal participants are adults who have never tried mindfulness or classic psychedelics and are willing to follow specific guidelines about caffeine and medication use. As a Phase 2 trial, this research measures how well the treatment works in an initial, smaller group, offering participants a chance to contribute to groundbreaking mental health advancements.

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.

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

Research has shown that psilocybin, when combined with mindfulness training, is generally safe and well-tolerated. One study found that using psilocybin with mindfulness-based stress reduction (MBSR) led to significant improvements in depression, demonstrating that the treatment was safe enough for participants to benefit.

Another study on psilocybin-assisted therapy in healthcare workers found the treatment to be safe, with no serious side effects. This suggests that psilocybin, when used responsibly and in a controlled environment, is safe for mental health treatment.

Since this trial is in Phase 2, the treatment has already passed initial safety tests in humans. This phase focuses on better understanding its effectiveness and safety. Participants receive close monitoring to manage any side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about mindfulness-assisted psilocybin therapy because it combines a psychedelic compound with mindfulness training to address mental health in a potentially transformative way. Unlike traditional antidepressants or psychotherapy, this approach uses psilocybin, a naturally occurring psychedelic, to potentially catalyze rapid changes in mood and perception. When paired with mindfulness techniques, this combination could enhance emotional processing and long-lasting mental health improvements, offering a novel and integrative treatment strategy that stands out from conventional methods.

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

This trial will compare two treatment approaches: Psilocybin only and Mindfulness-assisted psilocybin therapy. Studies have shown that combining psilocybin, a compound found in certain mushrooms, with mindfulness training can greatly improve mental health. For example, group therapy using psilocybin and mindfulness-based stress reduction (MBSR) reduced depression symptoms in participants. While psilocybin alone effectively treats depression, adding mindfulness may enhance these benefits. This combination might help people become more adaptable to stress and change. Research suggests that the positive effects of this treatment can last a long time. ^{2 3 5 6 7}

Who Is on the Research Team?

Baruch R Cahn, MD, PhD

Principal Investigator

University of Southern California

Are You a Good Fit for This Trial?

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

I take prescription medication for my mental health daily.

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

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

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06233344

NCT06233344 | Mindfulness-assisted Psychedelic Therapy Recent evidence suggests that the combination of psilocybin with mindfulness training may enhance the therapeutic effects of these interventions for mental ...

2. journals.plos.org journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1004519

Psilocybin-assisted group psychotherapy and mindfulness ... This trial met its primary endpoint: group psilocybin-assisted therapy plus MBSR was associated with clinically significant improvement in depressive symptoms ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12459851/

Psilocybin-assisted group psychotherapy and mindfulness ... We sought to evaluate the safety and preliminary efficacy of psilocybin and MBSR versus MBSR alone for frontline healthcare providers with symptoms of ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0163834325001562

A dose of therapy with psilocybin - A meta-analysis ... Psilocybin-assisted therapy (PAT) has shown promising effects in treating depressive symptoms, but the role of the therapeutic component remains unclear.

5. nature.com nature.com/articles/s41598-024-58318-x

Psychological flexibility as a mechanism of change in ... Psychological flexibility, several facets of mindfulness, and values-congruent living significantly improved following psilocybin and were maintained through ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06233344

NCT06233344 | Mindfulness-assisted Psychedelic Therapy Recent evidence suggests that the combination of psilocybin with mindfulness training may enhance the therapeutic effects of these interventions for mental ...

7. ptsd.va.gov ptsd.va.gov/professional/treat/txessentials/psychedelics_assisted_therapy.asp

Psychedelic-Assisted Therapy for PTSD This article focuses on the use of psilocybin- and MDMA-assisted therapy (P-AT and MDMA-AT) for the treatment of posttraumatic stress disorder (PTSD) in ...