Psilocybin-Assisted Therapy for Intergenerational Trauma

NCT ID: NCT06899165

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-28
• Study Completion Date: 2030-01-02

Brief Summary

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.

Detailed Description

This study is investigating whether Psilocybin-assisted therapy improves depression, anxiety and stress symptoms in the offspring (biological children) of genocide survivors. Intergenerational trauma is the concept that the effects of experiencing extreme stress can be perpetuated to future generations. A genocide here is defined by the extinction or threat of extinction of a racial, religious or ethnic group, by an oppressive regime. A genocide survivor here is defined by an individual who survived or escaped a genocide in their country of origin. Currently, there are no evidence-based treatments developed specifically for the syndrome associated with Intergenerational trauma. This study aims to assess the safety and tolerability of psilocybin-assisted therapy, and assess 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.

Participants will be asked to attend one or more screening visits to assess eligibility. If eligible, participants will be treated with two separate doses of the study medication, Psilocybin, 3-4 weeks apart. This is an open-label research study, meaning all participants will receive Psilocybin (25mg). Two trained clinical practitioners will work with participants across preparation, dosing, and integration processes. Participants will complete assessments throughout the study until their participation has ended. Safety measures are in place to check the overall health and well-being of participants

Participation will consist of:

• Screening Period (up to 4 weeks): Phone screen, informed consent, eligibility assessment.
• Tapering & Enrollment Period (variable): Enrollment, supervised medical tapering where necessary as discussed with the study doctor, biomarker collection and psychometric baseline assessments.
• Preparatory & Treatment Period (up to 14 weeks): Three preparatory sessions with study clinicians, assessments; two dosing days at least three weeks apart, three weekly integration sessions with study clinicians following each dose, a 72-hour check-in call after each dosing day, assessments.
• Follow-Up Period (up to 5 weeks): Follow-up one month after final integration session, assessments, clinical evaluation, biomarker collection

Conditions

Psychological Stress; Depression; Anxiety

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Psilocybin-Assisted Therapy

Offspring of genocide survivors with mood and anxiety disorders will undergo weekly therapy sessions and will be given 2 doses of psilocybin at least 3 weeks apart.

Group Type: EXPERIMENTAL

Psilocybin

Intervention Type: DRUG

Psilocybin 25mg, capsules taken orally under the supervision of two trained study therapists

Integration sessions

Intervention Type: BEHAVIORAL

weekly integration sessions (therapy) for 6 weeks

Interventions

Psilocybin

Psilocybin 25mg, capsules taken orally under the supervision of two trained study therapists

Intervention Type: DRUG

Integration sessions

weekly integration sessions (therapy) for 6 weeks

Intervention Type: BEHAVIORAL

Other Intervention Names

Psilocybin-Assisted Therapy

Eligibility Criteria

Inclusion 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rachel Yehuda

OTHER

Sponsor Role: lead

Responsible Party

Rachel Yehuda

Director of the Parsons Research Center for Psychedelic Healing, Professor of Psychiatry at Mount Sinai

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Rachel Yehuda, PhD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

The Parsons Research Center for Psychedelic Healing

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lauren Lepow, MD, PhD

Role: CONTACT

lauren.lepow@mountsinai.org

646-438-5044

Evelyn Alkin, MA

Role: CONTACT

IntergenStudy@mssm.edu

929-489-7440

Other Identifiers

STUDY-24-01320

Identifier Type: -

Identifier Source: org_study_id