RecruitingPhase 2

Psilocybin-Assisted Therapy for Intergenerational Trauma

Processing Intergenerational Trauma With Psilocybin-Assisted Therapy

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety of psilocybin-assisted therapy in adults whose parent survived genocide, the killing of a group of people. It also looks at whether the therapy helps depression, anxiety, stress, and the lasting effects of a parent's trauma, and improves the ability to cope.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be at least 18 and the biological child of at least one parent who directly survived or escaped genocide.
  • Have significant symptoms linked to a parent's trauma, based on a study questionnaire, and a diagnosed depression, anxiety, trauma, or stress-related disorder.
  • Have a body mass index (BMI), a measure based on height and weight, of at least 17.
  • Be able to give written consent, follow study rules, read and speak English fluently, and swallow pills.
  • Agree to use the required birth control throughout the study if you or your partner could become pregnant.
  • Be willing and medically able to stop medicines that affect serotonin, a brain chemical, and stay off them during the study. Do not change medicines before speaking with the study team; study doctors will review changes with your healthcare provider.
  • Agree to audio and video recording of all visits, share relevant medical and mental health records, and report medical conditions and procedures within 48 hours.
  • Provide an emergency contact and follow the study's lifestyle rules and other requirements.

Who can't join

  • You directly experienced the genocide, are pregnant or breastfeeding, are allergic to psilocybin, or have insulin-dependent diabetes.
  • You have a current or recent drug use disorder covered by the study's rules; alcohol or cannabis use that may affect safety or results; recent psychedelic use; recent non-medical or illegal ketamine use; or an unexplained positive drug test.
  • You have a past or current disorder involving loss of touch with reality, mania, or bipolar disorder; current anorexia or bulimia; or a parent, sibling, or child with psychosis, schizophrenia, a related disorder, or bipolar disorder.
  • You are in a mental health hospital or were admitted within the past 6 months, have a serious suicide risk or recent suicidal behavior, may harm yourself or others, or have a condition that prevents safe therapy.
  • You have a severe or unstable illness, major kidney or liver problems, a brain or nerve condition affecting participation, a disability that prevents completing study tests, or unsafe screening test results or vital signs.
  • You have certain heart or blood vessel problems, abnormal heart rhythm or heart test results, or a personal or family history of long QT syndrome, a problem with the heart's electrical timing.
  • You take medicines that cannot safely be stopped or changed and that conflict with study treatment or affect the heart's electrical timing.
  • You have a fall risk that staff cannot manage, or cannot name someone to take you home and stay overnight after the treatment session.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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. * Evidence of clinically significant intergenerational trauma-related symptoms, as determined by the modified Parental PTSD Questionnaire (mPPQ). * Meet diagnostic criteria for a depressive, anxiety, trauma-, or stressor-related disorder on the Structured Clinical Interview for DSM-5 (SCID-5). * BMI of ≥ 17. * Capable of providing written informed consent and complying with study procedures. * If of reproductive potential, willing to use a highly effective method of contraception throughout study participation. Participants who can father a child and have partners of reproductive potential must also agree to use effective contraception throughout study participation. * Willing and medically appropriate to discontinue serotonergic medications before study treatment and remain off such medications throughout study participation, as determined by the study physician in consultation with the participant's treating healthcare provider. * Fluent in speaking and reading English. * Able to swallow pills. * Agree to have all study visits (both in-person and remote) 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. * Must agree to inform the investigators within 48 hours of any medical conditions and procedures. * Agree to release relevant medical and psychiatric records for eligibility determination and safety monitoring. * Agree to comply with protocol-specified lifestyle restrictions and study requirements. Safety note (not incl./excl. criteria): Note to Potential Participants: Individuals interested in this study should not stop, taper, or otherwise change prescribed medications before speaking with the study team. Any medication changes required for study participation will be evaluated by qualified study clinicians and, when appropriate, coordinated with the participant's treating healthcare provider. Exclusion Criteria: * Individual was directly exposed to the genocide. * Current or recent illicit drug or prescription drug substance use disorder (excluding cannabis and tobacco use disorders), as determined by DSM-5 criteria and clinical assessment. * Current or recent alcohol or cannabis use disorder that, in the opinion of the investigator, may interfere with safe participation or study outcomes. * Current psychiatric hospitalization or psychiatric hospitalization within the last 6 months. * Recent use of psychedelic substances. * Recent non-medical or illicit use of ketamine. * Past or current psychotic disorder (including psychotic MDD), mania, or bipolar disorder. * Current serious suicide risk, recent suicidal behavior, or clinician concern that the participant poses a risk to self or others. * Acute, severe, or unstable medical illness, including clinical or laboratory evidence of severe renal and/or hepatic impairment. * Any physical or intellectual disability adversely affecting ability to complete assessments. * Current pregnancy or currently chest/breastfeeding. * Any clinically meaningful abnormal laboratory test result, as determined by the investigator. * Current treatment with medications contraindicated with study treatment that cannot be safely tapered, discontinued, or substituted in accordance with the protocol. * History of clinically significant QT prolongation or other clinically significant cardiac conduction abnormality. * Use of medications known to prolong the QT interval that cannot be safely discontinued. * Any congenital prolongation of the QT interval or a family history of long QT syndrome. * A family history in a first-degree relative of psychosis/schizophrenia or related disorders as assessed by clinical interview with Study MD. * A first-degree family history of bipolar disorder as assessed by clinical interview with Study MD. * Current anorexia nervosa or bulimia nervosa as determined by DSM-V criteria using the SCID-V. * A clinically meaningful history of cardiac arrhythmias or who require treatment with an antiarrhythmic medication. * Preexisting clinically meaningful cardiovascular conditions, including cardiac valvulopathy, pulmonary hypertension that may be worsened/exacerbated by elevated blood pressure or heart rate. * Neurological conditions including stroke, transient ischemic attack (TIA), epilepsy, neurodegenerative disease, brain tumor, or other neurological disorders that would impact participation in the trial. * Insulin-dependent diabetes. * Vital sign abnormalities at screening that exceed protocol-defined safety thresholds. * Hypersensitivity to psilocybin. * Psychiatric or other condition judged to be incompatible with establishment of rapport with therapy team and/or safe exposure to psilocybin. * Positive toxicology findings not adequately explained by prescribed medications or approved treatment regimens. * Clinically meaningful abnormalities on screening electrocardiogram (ECG). * Fall risk if not mitigated by assistance from study staff. * Can't identify a support person who will be able to accompany them home and stay the night with them post experimental session.

Study sites (1)

NY