Psilocybin-Assisted Therapy for Intergenerational Trauma

Overseen By Evelyn Alkin, MA

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Rachel Yehuda

Must not be taking: Psychiatric medications, Psychedelics

Disqualifiers: Genocide exposure, Stroke, Psychiatric hospitalization, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the use of psilocybin, a compound found in magic mushrooms, to assist children of genocide survivors who have mood or anxiety disorders. The goal is to determine if psilocybin-assisted therapy can safely reduce symptoms such as depression, anxiety, and stress, while enhancing psychological resilience. Participants will engage in weekly therapy sessions and receive two doses of psilocybin over several weeks. This trial suits individuals who are biological children of genocide survivors, have experienced depression or anxiety, and are willing to commit to the study's requirements. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant findings.

Do I have to stop taking my current medications for the trial?

The trial requires participants to safely taper off certain psychiatric medications, but it does not specify which ones. It's best to discuss your current medications with the study team to understand what changes might be needed.

Is there any evidence suggesting that psilocybin-assisted therapy is likely to be safe for humans?

Research has shown that psilocybin-assisted therapy is generally safe in controlled settings with medical supervision. Studies have found that while some people may experience temporary side effects like nausea or headaches, these effects are usually mild and short-lived, suggesting that psilocybin is well-tolerated.

Psilocybin has been studied for other conditions, and careful monitoring is crucial for ensuring safety. The therapy involves close observation by healthcare professionals to address any issues that might arise. Overall, current evidence supports the safety of psilocybin-assisted therapy in a supervised environment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard of care for mood and anxiety disorders, which often involves medications like SSRIs and psychotherapy, psilocybin-assisted therapy offers a unique approach by using psilocybin, a psychedelic compound. Researchers are excited about this treatment because psilocybin works by affecting serotonin receptors in the brain, potentially leading to profound emotional and psychological insights. This could offer faster and more lasting relief compared to traditional therapies. Additionally, the use of psychedelics in a controlled therapeutic setting is a novel method that might address underlying trauma in ways conventional treatments do not.

What evidence suggests that psilocybin-assisted therapy might be an effective treatment for mood and anxiety disorders?

Research has shown that psilocybin therapy can greatly reduce symptoms of PTSD, depression, and anxiety. In earlier studies, participants who took psilocybin experienced a significant decrease in depression symptoms after treatment. Some evidence also suggests that psilocybin enhances the brain's ability to grow and adapt, facilitating change and learning. This could make it particularly effective for addressing deep-seated emotional issues. Although further research is necessary, these findings offer promise for individuals dealing with mood and anxiety disorders, including those related to generational trauma. ^{1 2 3 6 7}

Who Is on the Research Team?

Rachel Yehuda, PhD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for offspring of genocide survivors who are experiencing mood and anxiety disorders. Participants should be dealing with symptoms like depression, anxiety, or stress potentially linked to their parents' experiences.

Inclusion Criteria

I can swallow pills.

Agrees to release of outside medical and psychiatric records

Biological child of at least one parent who directly survived/escaped a genocide

Exclusion Criteria

Current serious suicide risk

Has used psychedelics within 3 months of enrollment

Has a history of psychiatric hospitalization within the last 6 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

up to 4 weeks

Phone screen, informed consent, eligibility assessment

Tapering & Enrollment

Enrollment, supervised medical tapering where necessary, biomarker collection and psychometric baseline assessments

variable

Preparatory & Treatment

Three preparatory sessions, two dosing days at least three weeks apart, three weekly integration sessions following each dose, 72-hour check-in call after each dosing day, assessments

up to 14 weeks

Follow-up

Follow-up one month after final integration session, assessments, clinical evaluation, biomarker collection

up to 5 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Psilocybin

Trial Overview The study tests psilocybin-assisted therapy's safety and effectiveness in reducing mood and anxiety disorder symptoms. It includes integration sessions where participants discuss their experiences.

How Is the Trial Designed?

Group I: Psilocybin-Assisted Therapy Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

Rachel Yehuda

Lead Sponsor

Trials

2

Recruited

320+

Published Research Related to This Trial

Psilocybin, a serotonergic psychedelic, has shown promise in treating various psychiatric disorders, including depression and substance use disorders, with 9 clinical trials conducted between 2000 and 2020.

The treatment is generally well tolerated with limited side effects, and some patients with treatment-resistant conditions have experienced significant long-term improvements after just a few sessions, indicating its potential efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment with psilocybin: applications for patients with psychiatric disorders]. Breeksema, JJ., Koolen, MHB., Somers, M., et al.[2021]

A systematic review of 16 studies found that psilocybin is generally well-tolerated, with the most common side effects being transient nausea and headache, and no reports of severe long-term issues like psychosis.

Psilocybin shows promise as a safe treatment option for psychiatric and substance-dependence conditions, particularly for patients who do not respond to standard therapies, as it has demonstrated both acute and long-term safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Tolerability and Safety of Psilocybin in Psychiatric and Substance-Dependence Conditions: A Systematic Review. Kaminski, D., Reinert, JP.[2023]

In a survey of 1993 individuals who experienced challenging psilocybin trips, 39% rated their experience as one of the most difficult of their lives, with 11% reporting risks of physical harm, particularly influenced by dose and lack of support.

Despite the challenges, 84% of respondents felt they benefited from the experience, suggesting that while adverse effects can occur, the overall incidence of serious psychological distress is low, especially in controlled settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survey study of challenging experiences after ingesting psilocybin mushrooms: Acute and enduring positive and negative consequences. Carbonaro, TM., Bradstreet, MP., Barrett, FS., et al.[2018]

In a study of 27 patients with moderate to severe major depressive disorder, psilocybin-assisted treatment showed significant and lasting antidepressant effects, with 75% of participants experiencing a treatment response and 58% achieving remission after 12 months.

There were no serious adverse events related to psilocybin, indicating a favorable safety profile, and participants reported meaningful personal and spiritual experiences that correlated with increased well-being, although these did not directly predict improvements in depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of psilocybin-assisted treatment for major depressive disorder: Prospective 12-month follow-up. Gukasyan, N., Davis, AK., Barrett, FS., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06899165

Psilocybin-Assisted Therapy for Intergenerational Trauma This study is investigating whether Psilocybin-assisted therapy improves depression, anxiety and stress symptoms in the offspring (biological children) of ...

2. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/587395

Psilocybin-Assisted Therapy for Intergenerational Trauma The study will also investigate the efficacy of psilocybin-assisted therapy in reducing symptoms such as depression, anxiety and stress, as well as changes ...

3. withpower.com withpower.com/trial/phase-2-historical-trauma-5-2025-e34a2

Psilocybin-Assisted Therapy for Intergenerational Trauma Research shows that psilocybin-assisted therapy has promising results in reducing symptoms of PTSD, depression, and anxiety, with some studies indicating long- ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37844352/

Psilocybin-assisted therapy for depression: A systematic ... A review of open-label trials showed robust decreases in depressive symptoms following psilocybin administration. These findings provide preliminary evidence ...

5. ccjm.org ccjm.org/content/92/3/171

Psychedelic-assisted therapy: An overview for the internist For weeks after treatment, psychedelics appear to reopen critical periods for social learning and enhance neuroplasticity. This provides a ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9273054/

Psychedelic Therapies at the Crossroads of Trauma and ... This paper reviews the historical perspective of psychedelic research and practices, as well as the intersection of historical trauma, ACEs, PTSD, and SUDs ...

7. icahn.mssm.edu icahn.mssm.edu/research/center-psychedelic-parsons-research/research-clinical-trials

Psychedelic Clinical Trials and Research Clinical trials at the Center for Psychedelic Psychotherapy and Trauma Research explore the therapeutic potential of MDMA and psychedelic compounds.