Mindfulness-Assisted Psychedelic Therapy
ConditionMental Health
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age25+
SponsorUniversity of Southern California
About 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, computerized cognitive tests, and have an EEG (a measure of electrical activity in the brain) and functional MRI of brain if possible. 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.
Eligibility criteria
Qualifiers
Adults of any race, ethnicity, or gender who are age 25 years or older
Have not had formal mindfulness training
Have not previously used classic psychedelics
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.
Disqualifiers
None
Trial design
Treatments tested in this trial
- Psilocybin plus mindfulness training
- Psilocybin
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov