Psilocybin-Assisted Therapy for Intergenerational Trauma
This open-label Phase II trial (n=100) will study the safety, tolerability, and potential therapeutic effects of psilocybin (2 x 25 mg oral doses, taken at least 3 weeks apart) in the biological children of genocide survivors who are living with mood and anxiety disorders.
Detailed Description
Open-label, single-group Phase II study testing two supervised 25 mg oral doses of psilocybin given 3–4 weeks apart alongside preparatory and integration therapy in adult biological children of genocide survivors with depressive or anxiety disorders.
Primary aims are to assess safety and tolerability; secondary aims include changes in depression, anxiety, stress, psychological resilience, and effects related to parental exposure to genocide. Assessments include clinical scales and biomarker collection across screening, treatment, and follow-up.
Participants receive three preparatory sessions, two dosing days, and six integration sessions (three after each dose), with monitoring and safety checks including supervised tapering of prohibited medications when necessary.
Study Protocol
Preparation
Dosing
Integration
Therapeutic Protocol
Study Arms & Interventions
Psilocybin-Assisted Therapy
experimentalTwo supervised 25 mg psilocybin doses with preparatory and integration therapy.
Interventions
- Psilocybin25 mgvia Oral• two sessions• 2 doses total
Two 25 mg capsules administered 3–4 weeks apart under supervision of two trained clinicians.
- Compoundvia Other• weekly• 6 doses total
Preparatory and integration therapy: three preparatory sessions; three weekly integration sessions after each dose (6 total).
Participants
Inclusion 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
- 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.
Study Details
- StatusRecruiting
- PhasePhase II
- Typeinterventional
- DesignNon-randomized
- Target Enrollment100 participants
- TimelineStart: 2025-06-01End: 2030-02-01
- Compound
- Topic