RECRUITING

Psilocybin-Assisted Therapy for Intergenerational Trauma

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.

Study Overview

Study Details

Study overview

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.

Processing Intergenerational Trauma With Psilocybin-Assisted Therapy

Psilocybin-Assisted Therapy for Intergenerational Trauma

Condition
Psychological Stress
Intervention / Treatment

-

Contacts and Locations

New York

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Age at least 18 years old at time of signing the informed consent
  • * Biological child of at least one parent who directly survived/escaped a genocide
  • * Meets diagnostic criteria for a depressive or anxiety disorder
  • * Capable of providing informed consent and complying with study procedures
  • * Currently using or agreeing to use adequate contraceptive methods.
  • * Fluent in speaking and reading English
  • * Able to swallow pills
  • * Agrees to have study visits recorded with audio and video
  • * Able to provide a contact person who can be reached by investigators in the event of the participant becoming unwell or unreachable
  • * Agrees to inform the investigators within 48 hours of any medical conditions and procedures
  • * Agrees to release of outside medical and psychiatric records
  • * Must not participate in any other interventional clinical trials for the duration of the study.
  • * Must commit to medication dosing, therapy, and all study procedures.
  • * Not able to give adequate informed consent.
  • * Was directly exposed to or survived a genocide.
  • * Has a history of any medical condition, or any significant clinical finding on screening tests, that could make receiving psilocybin harmful.
  • * Has acute, severe or unstable medical illness.
  • * Has a history of stroke or Transient Ischemic Attack (TIA).
  • * Has a history of psychiatric hospitalization within the last 6 months.
  • * Current serious suicide risk.
  • * Unable or unwilling to safely taper off prohibited psychiatric medications.
  • * Abusing alcohol or other substances.
  • * Has used psychedelics within 3 months of enrollment.
  • * Are pregnant or nursing or able to become pregnant and are not practicing an effective means of contraception.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Rachel Yehuda,

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

Study Record Dates

2030-01-02