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

Trial Summary

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.

What data supports the effectiveness of the drug psilocybin for treating intergenerational trauma?

Research shows that psilocybin-assisted therapy has promising results in reducing symptoms of PTSD, depression, and anxiety, with some studies indicating long-term positive effects after just a few doses. Although not specifically tested for intergenerational trauma, these findings suggest potential benefits for related conditions. ^{1 2 3 4 5}

Is psilocybin-assisted therapy generally safe for humans?

Psilocybin-assisted therapy is generally considered safe when administered in controlled settings with medical supervision. Some studies report that while challenging experiences can occur, the risk of serious harm is low, especially in laboratory settings with screened and supported participants. ^{1 2 4 6 7}

How is the drug psilocybin unique in treating intergenerational trauma?

Psilocybin is unique because it is a psychedelic that can lead to long-term positive effects after just one or a few doses, and it is administered under medical supervision to help patients confront traumatic memories and increase self-compassion, which is different from traditional treatments that often require ongoing medication or therapy sessions. ^{1 2 4 5 8}

What is the purpose of 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.

Research Team

Rachel Yehuda, PhD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Study protocol of an open-label proof-of-concept trial examining the safety and clinical efficacy of psilocybin-assisted therapy for veterans with PTSD. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

[Psilocybin-Assisted Treatment of Depression, Anxiety and Substance use Disorders: Neurobiological Basis and Clinical Application]. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of psilocybin-assisted treatment for major depressive disorder: Prospective 12-month follow-up. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Psilocybin for Trauma-Related Disorders. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

[Treatment with psilocybin: applications for patients with psychiatric disorders]. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Survey study of challenging experiences after ingesting psilocybin mushrooms: Acute and enduring positive and negative consequences. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

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

8. Germany pubmed.ncbi.nlm.nih.gov

Psilocybin for the Treatment of Depression: A Promising New Pharmacotherapy Approach. [2023]