Clinical TrialImplementation & Service DeliveryMDMALSDPsilocybinEnrolling by invitation

The Role of Personal Experience for the Therapeutic Attitude in the Context of Substance-assisted Therapy Training (TherPsySE)

Single-group interventional study (n=48) assessing effects of personal psychedelic experience (MDMA, LSD, psilocybin) on therapists' therapeutic attitude and related capacities during SÄPT training.

Target Enrollment
48 participants
Study Type
Phase NA interventional
Design
Non-randomized

Detailed Description

TherPsySE follows physicians and psychotherapists participating in SÄPT training to evaluate risks and benefits of personal experience with substance-induced altered states (MDMA, LSD, psilocybin) for therapeutic attitude, empathy and cognitive flexibility.

Interventions include group and 1:1 dosing sessions: MDMA (2×100 mg), LSD (75 and 150 µg) and psilocybin (15 and 25 mg); several non-drug study days focus on role-taking and training exercises.

Study Arms & Interventions

Personal experience

experimental

Therapist personal experience with MDMA, LSD and psilocybin during SÄPT training (group and 1:1 settings).

Interventions

  • MDMA200 mg
    via Oral• single dose

    2 × 100 mg oral (group setting).

  • LSD75 - 150 µg
    via Oral• single dose

    LSD 75 and 150 µg in 1:1 setting.

  • Psilocybin15 - 25 mg
    via Oral• single dose

    Psilocybin 15 and 25 mg (group setting).

Participants

Ages
27 – 99
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • Participation in the SÄPT therapist training (medical doctors and psychologists)
  • Age 27 years or older
  • Sufficient understanding of the German language
  • Understanding of procedures and risks associated with the study
  • Willing to adhere to the protocol and signing of the consent form
  • Willing not to operate heavy machinery (including driving cars) within 24 hours after substance administration
  • Women of childbearing potential required to use effective contraception (oral, injected or implanted hormonal methods; IUD/IUS; barrier methods with spermicide) at least one month before and after each study substance intervention, and to take a urine pregnancy test at screening and before every study substance intervention
  • Men required to use contraceptive methods in the month after each study substance intervention and to inform partner(s) about study participation.

Exclusion Criteria

  • Exclusion Criteria:
  • Previous significant adverse response to a hallucinogenic drug
  • Significant medical condition rendering volunteers unsuitable for participation (e.g., impaired kidney or liver function, heart disease including uncontrolled hypertension or hypotension)
  • Strong underweight (<45 kg)
  • Current major psychiatric disorder (including personality disorder and suicidality) and/or previous psychotic or bipolar disorder
  • Psychotic disorder or bipolar disorder in first-degree relatives
  • Use of medication that may interfere with the effects of the study medication; willingness to discontinue medications with an appropriate washout (typically ≥5 half-lives, ~3–7 days) if judged acceptable by investigator
  • Women excluded during pregnancy or breastfeeding
  • Participation in another clinical trial currently or within the last 30 days

Study Details

Locations

University Hospital Basel — Basel, Switzerland

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