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

Last updated: April 11, 2025
Sponsor: Felix Mueller
Overall Status: Active - Enrolling

Phase

N/A

Condition

N/A

Treatment

MDMA, LSD, psilocybin

Clinical Study ID

NCT05570708
2022-01173
  • Ages > 27
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The study investigates two groups of participants of the SÄPT therapist's training starting in October 2022. The overall objective is to investigate the risks and benefits of personal experience (PE) with substance-induced altered states of consciousness for physicians or psychotherapists in the context of a training course for substance-assisted therapy. Specifically, the study aims to assess changes in therapeutic attitude and other factors important in interactions between patients and therapists (such as empathy and cognitive flexibility).

Eligibility Criteria

Inclusion

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 hoursafter substance administration

  • Woman of childbearing potential are required to use effective, establishedcontraception, such as oral, injected or implanted hormonal methods ofcontraception, placement of an intrauterine device (IUD) or intrauterine system (IUS), barrier methods of contraception: condom or occlusive cap (diaphragm orcervical/vault caps) with spermicidal foam/gel/film/cream/suppository at least onemonth before and after each study substance intervention, and are willing to take aurine pregnancy test at the medical screening and before every study substanceintervention.

  • Men are required to use contraceptive methods in the month after each studysubstance intervention and are required to inform their partner(s) about their studyparticipation.

Exclusion

Exclusion Criteria:

  • Previous significant adverse response to a hallucinogenic drug

  • Significant medical condition rendering volunteers unsuitable for participation (such as impaired kidney or liver function, or heart disease incl. uncontrolledhypertension or hypotension)

  • Strong underweight (<45kg)

  • Current major psychiatric disorder (including personality disorder, includingsuicidality) 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.Patients must be willing to discontinue medications in cases where drug-relatedinteractions are possible (the washout phase will be at least 5 times the particulardrug's half-life [typically 3-7 days] prior to the respective study session).Discontinuation of medication must be judged to be acceptable by the responsibleinvestigator.

  • Women are excluded from substance intervention during pregnancy or breastfeeding.

  • nParticipation in another clinical trial (currently or within the last 30 days)

Study Design

Total Participants: 48
Treatment Group(s): 1
Primary Treatment: MDMA, LSD, psilocybin
Phase:
Study Start date:
October 25, 2022
Estimated Completion Date:
June 01, 2029

Connect with a study center

  • University Hospital Basel

    Basel, 4031
    Switzerland

    Site Not Available

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