A study of the psychological, cognitive and physiological effects of Psychedelic Medicines (ASSESS)
- Conditions
- Mental Health - DepressionMental Health
- Registration Number
- ACTRN12622001535763
- Lead Sponsor
- Monarch Mental Health Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
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.
- 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.
- Have insulin-dependent diabetes.
- Nicotine dependence that would disallow an individual to be nicotine free for the 7-10 hours during the dosing period.
- Current or previous diagnosis of schizophrenia spectrum or other psychotic disorders, including major depressive disorder with psychotic features, or Bipolar I or Bipolar II Disorder.
- Or an immediate family member with a diagnosed psychotic disorder or meeting the DSM-5 criteria for any of these disorders.
- Current or previous diagnosis of alcohol or drug use disorder, or meeting the DSM-5 criteria for either of these disorders.
- History of serious suicide attempts requiring hospitalisation, or any participant presenting current serious suicide risk, as determined through meeting criteria on the Columbia Suicide Severity Rating Scale (C-SSRS) (participants will be excluded if they meet criteria on this scale).
- Significant history of mania.
- Any other psychiatric condition judged to be incompatible with safe exposure to psilocybin, e.g. borderline personality disorder.
- Positive pregnancy test at screening or during the study, women who are planning a pregnancy and/or women who are nursing/breastfeeding. Any person with female reproductive organs and of childbearing potential will undertake a pregnancy test as part of the study prior to any dosing of MDMA or psilocybin.
- Participants who do not agree to use an acceptable contraceptive method throughout their participation in study.
- Use of contraindicated medication (outlined further below).
- Previous experience with MDMA or psilocybin in the past three months.
- Current or previous diagnosis of antisocial personality disorder, or meeting the DSM-5 criteria for this disorder, or any other significant personality disorder as determined by the Standardized Assessment of Personality: Abbreviated Scale (SAPAS; Moran et al., 2003).
- Participants who weigh less than 48kg.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method