A study of the psychological, cognitive and physiological effects of Psychedelic Medicines on healthy individuals (ASSESS)

Monarch Mental Health Group0 sites100 target enrollmentDecember 12, 2022

ConditionsMental Health Mental Health - Depression

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Mental Health
Sponsor: Monarch Mental Health Group
Enrollment: 100
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

December 12, 2022

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Monarch Mental Health Group

Eligibility Criteria

Inclusion Criteria

•Participants will be healthy individuals who have undergone training in psychedelic assisted psychotherapy. Participants can be included if they are between the ages of 21 and 70, and voluntarily consent to participate after demonstrating competence to consent following discussion with one of the study researchers. Additional inclusion criteria will be:
•\- Participants must be able to swallow capsules.
•\- If of childbearing potential, agree to practice an effective means of birth control throughout the duration of the study.
•\- Participants must have an identified support person and agree to be accompanied home by that person following dosing be in the presence of that person until the next day.
•\- Agree to not operate a vehicle for at least 48 hours after initial drug administration. Participants must have transportation available after the Experimental Session and through the following day. Participants will also be warned that the substances will be potentially detectable in roadside drug tests for a number of days after ingestion.
•\- Must provide a contact (relative, spouse, close friend, or other caregiver) who is willing and able to be reached by the investigator in the event of an emergency or if the participant is unreachable.
•\- Must agree to inform the investigator within 48 hours if any medical conditions occur or medical procedures are planned.
•\- Are proficient in speaking and reading English.
•\- Have completed a Certificate in Psychedelic\-Assisted Therapies course.

Exclusion Criteria

•\- Participants who are not able to give adequate informed consent.
•\- Participants will be excluded if they are pregnant or lactating, have a history of neurological or mental illness or substance abuse or dependence. Participants will also be excluded if taking medication or drugs known to alter brain activity or have a history of seizures.
•\- Have any of the following cardiovascular conditions: uncontrolled hypertension, coronary artery disease, congenital long QT syndrome, cardiac hypertrophy, cardiac ischemia, congestive heart failure, myocardial infarction, tachycardia, artificial heart valve, a clinically significant screening ECG abnormality, or any other significant cardiovascular condition.
•\- Participants who are older than 40 years with a positive family history (in a first degree relative) of coronary heart disease and/or presenting substantive risk factors for cardiovascular disease as determined judged by a study doctor.
•\- Have a history of ventricular arrhythmia at any time, other than occasional premature ventricular contractions (PVCs) in the absence of ischemic heart disease.
•\- Have Wolff\-Parkinson\-White syndrome or any other accessory pathway that has not been successfully eliminated by ablation.
•\- Moderate to severe previous or current head injury/Traumatic Brain Injury (TBI).
•\- Have a history of stroke or Transient Ischemic Attack (TIA).
•\- Have moderate to severe hepatic impairment.
•\- Have epilepsy.