Psilocybin-Assisted Therapy for Intergenerational Trauma

Processing Intergenerational Trauma With Psilocybin-Assisted Therapy

Psilocybin-Assisted Therapy for Intergenerational Trauma (NCT06899165) is a Phase 2 interventional studying Psychological Stress and Depression, sponsored by Rachel Yehuda. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Psychological Stress and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 100 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Psychological Stress subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Age at least 18 years old at time of signing the willing to sign a consent form - 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 willing to sign a consent form 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. Who Should NOT Join This Trial: - Not able to give adequate willing to sign a consent form. - 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. Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DRUG

Psilocybin

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

BEHAVIORAL

Integration sessions

weekly integration sessions (therapy) for 6 weeks

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

The Parsons Research Center for Psychedelic Healing

New York, New York, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06899165), the sponsor (Rachel Yehuda), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06899165 clinical trial studying?

Who can participate in NCT06899165?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06899165?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06899165. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06899165. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.