RECRUITING

Mindfulness-assisted Psychedelic Therapy

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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). 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.

Official Title

An Exploratory Study of Feasibility, Efficacy, and Mechanisms of Mindfulness-Assisted Psychedelic Therapy

Quick Facts

Study Start:2025-07-30
Study Completion:2027-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06233344

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:25 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Baruch R Cahn, MD, PhD
CONTACT
858-366-3615
bcahn@usc.edu
Mary Falcone, PhD
CONTACT
mary.falcone@med.usc.edu

Principal Investigator

Baruch R Cahn, MD, PhD
PRINCIPAL_INVESTIGATOR
University of Southern California

Study Locations (Sites)

Univeristy of Southern California Brain and Creativity Institute
Los Angeles, California, 90089
United States

Collaborators and Investigators

Sponsor: University of Southern California

  • Baruch R Cahn, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Southern California

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-30
Study Completion Date2027-08

Study Record Updates

Study Start Date2025-07-30
Study Completion Date2027-08

Terms related to this study

Keywords Provided by Researchers

  • Psychedelic therapy
  • Psilocybin
  • Mindfulness

Additional Relevant MeSH Terms

  • Mental Health