WithdrawnPhase 2psilocybin
Precision Phenotyping of Behavioral Risk and Response to Electromagnetic and Psychedelic Therapies
Sponsored by University of New Mexico
NCT ID
NCT07484906
Start Date
2026-05-01
Est. Completion
2029-08-31
About This Study
PRE-EMPT will assemble a study group of 150 civilian and Veteran participants from three populations (low risk, intermediate risk, and high risk for self-harm). The investigators will obtain clinical assessments, MRI, and blood levels for circular RNA (circRNA). The teams will then administer three interventions (neurofeedback, transcranial magnetic stimulation, and psilocybin assisted therapy), and repeat the tests above. A team with expertise in artificial intelligence will then use our data to try to find patterns that identify who is at high risk versus low risk with a high degree of accuracy.
Conditions Studied
Interventions
- •fMRI Neurofeedback
- •Accelerated theta burst stimulation
- •Psilocybin assisted therapy
Eligibility
Age:18 Years - 69 Years
Healthy Volunteers:No
View full eligibility criteria
Inclusion Criteria: 1. 18-69 years old 2. Have been on a stable psychiatric medication regimen for at least four weeks prior to study participation. Exclusion Criteria: 1. A prior history of other central nervous system disease or any history of seizures; 2. history of psychotic disorders (e.g., schizophrenia, schizoaffective disorder, bipolar disorder type I); 3. history of current or recent (within two years) substance/alcohol use disorder, with the exception of tobacco use disorder; 4. meet criteria for Very High risk of suicide, or require inpatient hospital-level care for psychiatric reasons at time of consent, to reduce exacerbation of risk of harm to self during study; 5. presence of any implanted metal or electrical device (e.g. pacemaker); 6. recent medical hospitalization (within three weeks); 7. any condition that would prevent the participant from completing the protocol, such as significant agitation; 8. appointment of a legal representative or treatment guardian; 9. any ongoing litigation related to a health condition; 10. any other contraindication to exposure to strong magnetic fields or MRI, such as severe claustrophobia; 11. pregnancy or lactation; 12. a family history of schizophrenia or schizoaffective disorder (first or second degree relatives), or bipolar disorder type 1 (first degree relatives), to reduce risk of exacerbation of an undiagnosed psychotic condition; 13. other medical conditions that would preclude safe participation in the trial (e.g., decompensated heart failure); 14. starting or planning to start psychotherapy or changing the frequency or intensity of existing psychotherapy during the trial (current psychotherapy can be continued provided the frequency and intensity has been stable for ≥2 months prior to screening); 15. membership in a vulnerable population (minors, prisoners); 16. any contraindication for blood draws.