RECRUITING

Investigation to Understand and Optimize Psilocybin

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

This study will examine the effects of a single dose of psilocybin, administered with psychological support, on symptoms of depression. It will also assess whether different post-dosing interventions, including a non-invasive technique called transcutaneous auricular Vagus Nerve Stimulation (taVNS), influence various psychological and behavioral outcomes. In addition, the study will explore objective measures of real-world social behavior and identify early behavioral responses that may be associated with long-term treatment outcomes.

Official Title

An Investigation of Strategies to Understand and Optimize the Antidepressant Effects of Psilocybin (The OPTIMIZE Study)

Quick Facts

Study Start:2025-05-13
Study Completion:2029-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06512194

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:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
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

Program Manager
CONTACT
(970) 855-7374
bhic@vailhealth.org

Principal Investigator

Charles Raison, MD
PRINCIPAL_INVESTIGATOR
Vail Health Behavioral Health

Study Locations (Sites)

Vail Health Behavioral Health
Edwards, Colorado, 81632
United States

Collaborators and Investigators

Sponsor: Charles Raison

  • Charles Raison, MD, PRINCIPAL_INVESTIGATOR, Vail Health Behavioral Health

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 Date2025-05-13
Study Completion Date2029-05

Study Record Updates

Study Start Date2025-05-13
Study Completion Date2029-05

Terms related to this study

Keywords Provided by Researchers

  • depression
  • psilocybin
  • psychedelics
  • transcutaneous auricular vagus nerve stimulation
  • depressive symptoms
  • well-being
  • adverse events
  • ecological momentary assessment
  • electronically activated recorder
  • dynamical complexity assessment

Additional Relevant MeSH Terms

  • Depression