A study of the psychological, cognitive and physiological effects of Psychedelic Medicines (ASSESS)
A study of the psychological, cognitive and physiological effects of Psychedelic Medicines on healthy individuals (ASSESS)
Monarch Mental Health Group
50 participants
Sep 26, 2023
Interventional
Conditions
Summary
The primary objective of this project is to investigate psychological, cognitive and physiological changes associated with a single session of psychedelic drug exposure with psilocybin or 3,4-methylenedioxymethamphetamine (MDMA) in a group setting. Specifically, the study aims to use measures of psychological experience, cognitive function and electroencephalography (EEG) before and after psychedelic exposure. Secondary aims are (1) to assess changes in neural activity during acute substance exposure, (2) to determine whether tolerability is similar to previous studies, (3) to determine whether any pre-post differences we detect with the primary sample are replicated in a smaller sample who enter into a cross-over arm, taking the substance they did not take in the first instance, and (4) whether exposure to psychedelic drugs impacts self-assessed therapist competency. As both psilocybin and MDMA are becoming more commonly used to treat psychiatric illnesses, this study is important to improve our understanding of the mechanisms of action of these drugs. In addition, this study will contribute to enhancing the delivery of psychedelic therapies by identifying whether psychedelic dosing in a group setting is associated with improved outcomes, and whether exposure to psychedelic medicines enhances clinical self-rated competency. As such, this study will have the potential to be highly beneficial in improving our understanding of these drugs, and how to apply them, as they transition towards broad scale implementation as therapies for psychiatric conditions.
Eligibility
Inclusion Criteria8
- 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 Criteria24
- 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.
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Interventions
Participants will undergo a single drug exposure session with either psilocybin or Methylenedioxymethamphetamine (MDMA). This may occur individually or in small groups of 2-6 individuals within a session, all of whom will receive the same substance. The selection of group size will be based on participant and study staff availability. The selection of which substance each participant will receive will be based on participant preference. Since between substance comparisons are not primary aims, this non-random allocation will not pose any issue for the validity of the study. It will, however, improve participant tolerance of the substance, as receiving the substance of their preference is likely to lead to a more acceptable experience. Dosing sessions will be supported all times by two therapists (one male and one female) for the duration of the experience, in comfortable surroundings. The dosing session will last approximately 8 hours, during which time participants will sit in comfortable chairs with access to blindfolds and music if they would like. In the MDMA sessions, participants will be more likely to engage in a group discussion, while in the psilocybin session they will be more likely to use the blindfolds and listen to music. However, this will be up to participant preference. Prior to the dosing session, participants will undergo a preparatory session with one of the therapists who will supervise the dosing session, in order to orient participants to the experiences they will have in the session. This preparatory session will last between 45 minutes and 1.5 hours, and will involve a semi-structured conversation with considerable time for answering participant questions. Some participants may return for a second series of sessions, where they will receive the drug they did not receive in the first session. For example, if they were administered MDMA initially, the second session will involve psilocybin. The selection of these participants will be based on participant choice and study staff and resource availability. This second session will take place at least 3 months following the first session. For the psilocybin arm of the study, a single dose of 25 mg of psilocybin will be provided for a person weighing under 90 kg. A single dose of 30 mg of psilocybin will be provided for a person weighing between 90 kg and 115 kg. A single dose of 35 mg of psilocybin will be provided for a person weighing over 115 kg. For the MDMA arm of the study, a single dose of 80 mg of MDMA will be provided, followed by an optional half-dose of 40 mg between 1 and 4 hours after the initial dose. Both the MDMA and psilocybin will be orally administered in capsule form under the supervision of study personnel.
Locations(1)
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ACTRN12622001535763