Psilocybin-Assisted Therapy for Intergenerational Trauma

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.

Eligibility

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.

Conditions3

Locations1 site

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