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New treatment option for Psychological Stress
Official title Psilocybin-Assisted Therapy for Intergenerational Trauma
ClinicalTrials.gov ID: NCT06899165
What this study is testing
What is Psilocybin?
Psilocybin is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for psychological stress.
Also referred to as Psilocybin-Assisted Therapy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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 treatment clinical trials for the duration of the study.
- Must commit to medication dosing, therapy, and all study procedures.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.