Clinical TrialHealthy VolunteersPsilocybinMDMARecruiting

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

This non-randomized trial (n=100) investigates the psychological, cognitive, and physiological effects of a single session of psychedelic drug exposure with either psilocybin or MDMA in a group setting.

Target Enrollment
100 participants
Study Type
Phase II/III interventional
Design
Non-randomized

Detailed Description

Open, non-randomised interventional study of single-dose psilocybin or MDMA in healthy, trained participants; allocation by participant preference with sessions delivered individually or in small groups (2–6).

Dosing sessions last ~8 hours with two therapists present; a preparatory session (45–90 minutes) is provided. Primary assessments include psychological, cognitive and physiological measures (e.g., DASS), with secondary electrophysiological outcomes such as EEG N100.

A subset of participants may optionally cross over to receive the alternate substance at least three months later; outcomes are repeated pre- and post-exposure.

Study Protocol

Preparation

1 sessions
90 min each

Dosing

1 sessions
480 min each

Integration

sessions

Therapeutic Protocol

support

Study Arms & Interventions

Psilocybin

experimental

Single oral psilocybin session (weight-tiered dosing); sessions may be individual or small groups (2–6).

Interventions

  • Psilocybin25 - 35 mg
    via Oral• single dose• 1 doses total

    Weight-tiered single dose: 25 mg (<90 kg), 30 mg (90–115 kg), 35 mg (>115 kg). Administered in capsule form.

MDMA

experimental

Single oral MDMA session with optional booster; sessions may be individual or small groups (2–6).

Interventions

  • MDMA80 mg
    via Oral• single dose• 2 doses total

    80 mg initial dose with optional half-dose booster of 40 mg between 1 and 4 hours after initial dose; booster optional.

Participants

Ages
21 – 70
Sexes
Male & Female

Inclusion Criteria

  • Participants will be healthy individuals who have undergone training in psychedelic assisted psychotherapy.
  • Aged 21–70 years; voluntary informed consent and demonstrated competence to consent;
  • Able to swallow capsules;
  • If of childbearing potential, agree to use effective birth control throughout study;
  • Have an identified support person and agree to be accompanied home and be in the presence of that person until the next day;
  • Agree not to operate a vehicle for at least 48 hours after initial drug administration and have transportation available through the following day;
  • Provide a contact person reachable by investigator in an emergency;
  • Agree to inform the investigator within 48 hours of any medical conditions or procedures occurring;
  • Proficient in English;
  • Have completed a Certificate in Psychedelic-Assisted Therapies course.

Exclusion Criteria

  • Unable to give adequate informed consent;
  • Pregnant or lactating persons, planning pregnancy, or positive pregnancy test at screening;
  • History of neurological or significant mental illness, including current or past diagnosis of schizophrenia spectrum or other psychotic disorders, major depressive disorder with psychotic features, Bipolar I or II;
  • Current or previous diagnosis of alcohol or drug use disorder (DSM-5) or substance dependence;
  • Current serious suicide risk or history of serious suicide attempts requiring hospitalisation; participants meeting C-SSRS exclusion criteria will be excluded;
  • Significant history of mania;
  • Borderline personality disorder or other psychiatric conditions judged incompatible with safe exposure;
  • Use of medications or drugs known to alter brain activity or contraindicated medications (outlined in protocol);
  • History of seizures or epilepsy;
  • Moderate to severe previous or current head injury/TBI;
  • History of stroke or TIA;
  • Moderate to severe hepatic impairment;
  • Insulin-dependent diabetes;
  • Nicotine dependence preventing nicotine abstinence for required dosing period;
  • Cardiovascular conditions including uncontrolled hypertension, coronary artery disease, congenital long QT syndrome, cardiac hypertrophy, cardiac ischemia, congestive heart failure, myocardial infarction, tachycardia, artificial heart valve, clinically significant ECG abnormalities, ventricular arrhythmia (other than occasional PVCs without ischemic heart disease), Wolff–Parkinson–White syndrome or untreated accessory pathway;
  • Participants older than 40 years with a positive family history of coronary heart disease and/or substantial cardiovascular risk factors as judged by study doctor;
  • Previous experience with MDMA or psilocybin in past three months;
  • Current or previous antisocial personality disorder or other significant personality disorder as determined by SAPAS;
  • Participants who weigh less than 48 kg.

Study Details

  • Status
    Recruiting
  • Phase
    Phase IIPhase III
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment100 participants
  • Timeline
    Start: 2023-09-26
    End: 2026-01-12
  • Compounds
    PsilocybinMDMA
  • Topic
    Healthy Volunteers

Locations

Unknown facility — Australia

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