RECRUITING

Psilocybin-Assisted Therapy for Intergenerational Trauma

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 is an open-label psilocybin-assisted therapy study that will examine the safety and tolerability of psilocybin-assisted therapy in the offspring of genocide survivors with mood and anxiety disorders. The study will also investigate the efficacy of psilocybin-assisted therapy in reducing symptoms such as depression, anxiety and stress, as well as changes to the psychological effects of parental exposure to genocide, and changes to psychological resilience.

Official Title

Processing Intergenerational Trauma With Psilocybin-Assisted Therapy

Quick Facts

Study Start:2025-08-28
Study Completion:2030-01-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06899165

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
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age at least 18 years old at time of signing the informed consent
  2. * Biological child of at least one parent who directly survived/escaped a genocide
  3. * Meets diagnostic criteria for a depressive or anxiety disorder
  4. * Capable of providing informed consent and complying with study procedures
  5. * Currently using or agreeing to use adequate contraceptive methods.
  6. * Fluent in speaking and reading English
  7. * Able to swallow pills
  8. * Agrees to have study visits recorded with audio and video
  9. * Able to provide a contact person who can be reached by investigators in the event of the participant becoming unwell or unreachable
  10. * Agrees to inform the investigators within 48 hours of any medical conditions and procedures
  11. * Agrees to release of outside medical and psychiatric records
  12. * Must not participate in any other interventional clinical trials for the duration of the study.
  13. * Must commit to medication dosing, therapy, and all study procedures.
  1. * Not able to give adequate informed consent.
  2. * Was directly exposed to or survived a genocide.
  3. * Has a history of any medical condition, or any significant clinical finding on screening tests, that could make receiving psilocybin harmful.
  4. * Has acute, severe or unstable medical illness.
  5. * Has a history of stroke or Transient Ischemic Attack (TIA).
  6. * Has a history of psychiatric hospitalization within the last 6 months.
  7. * Current serious suicide risk.
  8. * Unable or unwilling to safely taper off prohibited psychiatric medications.
  9. * Abusing alcohol or other substances.
  10. * Has used psychedelics within 3 months of enrollment.
  11. * Are pregnant or nursing or able to become pregnant and are not practicing an effective means of contraception.

Contacts and Locations

Study Contact

Lauren Lepow, MD, PhD
CONTACT
646-438-5044
lauren.lepow@mountsinai.org
Evelyn Alkin, MA
CONTACT
929-489-7440
IntergenStudy@mssm.edu

Principal Investigator

Rachel Yehuda, PhD
PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai

Study Locations (Sites)

The Parsons Research Center for Psychedelic Healing
New York, New York, 10025
United States

Collaborators and Investigators

Sponsor: Rachel Yehuda

  • Rachel Yehuda, PhD, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai

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 Date2025-08-28
Study Completion Date2030-01-02

Study Record Updates

Study Start Date2025-08-28
Study Completion Date2030-01-02

Terms related to this study

Keywords Provided by Researchers

  • psilocybin
  • psilocybin-assisted therapy
  • intergenerational trauma
  • psychedelic
  • stress
  • genocide

Additional Relevant MeSH Terms

  • Psychological Stress
  • Depression
  • Anxiety