Mindfulness and Psilocybin in Healthy Adults: A Comparative Study
The Mindful Psilocybin Study: A three-arm, open-label, randomised controlled pilot trial in healthy volunteers examining the interaction between mindfulness training and psilocybin on wellbeing and psychological, physiological and behavioural measures
Monash University
45 participants
Mar 31, 2026
Interventional
Conditions
Summary
Mindfulness training and psilocybin interventions are both promising approaches for supporting mental health and wellbeing, and may have complementary or synergistic effects when used together. The Psil-oMM study aims to examine the combined and independent effects of mindfulness training and psilocybin by comparing three conditions in 45 healthy volunteers: a 4-week mindfulness intervention, a single high-dose psilocybin session with psychological support, and a combined mindfulness plus psilocybin intervention. The primary outcome is wellbeing, assessed using the Warwick–Edinburgh Mental Wellbeing Scale (WEMWBS).
Eligibility
Inclusion Criteria3
- Be aged 18 to 75 years.
- Be medically stable, as determined by screening for medical problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and routine medical blood laboratory tests.
- If of childbearing potential, must not be pregnant or breast-feeding at screening, must have a negative pregnancy test prior to dosing session, and must agree to use adequate birth control from screening through 10 days after the dosing session.
Exclusion Criteria16
- Have a lifetime history of meeting DSM-5 criteria for Schizophrenia, other Psychotic Disorder, Dissociative Identity Disorder, or Bipolar I or II Disorder or other mood disorder with psychotic features.
- Have a first-degree relative with diagnosed Schizophrenia, other Psychotic Disorder or Bipolar I disorder or mood disorder with psychotic features.
- Have a current or past year history of meeting criteria for any DSM-5 disorder or other subclinical psychiatric symptoms determined by the PI or Study Physician to be incompatible with inclusion in a healthy sample
- Have current suicide risk.
- Have any current contextual problem which, in the opinion of the PI or Study Physician might interfere with safe participation.
- At screening, use of excluded medications, unless explicitly agreed in writing by the Study Physician.
- Require ongoing concomitant therapy with a psychiatric medication for management of suicidal ideation.
- Require ongoing concomitant therapy with an excluded medication.
- Are above thresholds for prior use of a classical psychedelic.
- Are above thresholds for prior mindfulness experience.
- Have cardiovascular conditions, as specified in the study protocol.
- Have a disorder with known CNS involvement, or other major CNS disease.
- Have a diagnosis of epilepsy or previous seizures.
- Have certain chronic medical conditions, as specified in the study protocol.
- Weigh less than 48 kilograms or BMI < 17.
- Are pregnant or nursing, or able to become pregnant and are not willing to practice contraception.
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Interventions
This study includes three intervention conditions: 1. Psilocybin alone 2. Mindfulness alone (described under Comparator/Control Treatment) 3. Combined mindfulness plus psilocybin Psilocybin intervention Participants will receive a single oral dose of psilocybin (25 mg tablet) administered on-site under medical and psychological supervision. The intervention includes: -Preparation: two sessions (one online ~2 weeks prior; one in-person ~1 week prior) -Dosing session: supervised administration with two trained facilitators; safety screening conducted on the day (pregnancy, alcohol, and drug use); participants must nominate a support person for transport -Integration: two sessions (one in-person the day after dosing; one online within the following week) All procedures follow established best-practice approaches for participant preparation, safety monitoring, and psychological support used in prior clinical psilocybin trials. Adherence/accountability: on-site administration under staff supervision with full drug accountability. Combined intervention Participants complete the 4-week online mindfulness program (see Comparator/Control) followed by psilocybin dosing in Week 5, with identical preparation, dosing, and integration procedures as above.
Locations(1)
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ACTRN12626000246381