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

NCT05570708 · TherPsySE · Felix Mueller

Closed to entry
Status
Not accepting participants
Not applicable
Phase
48
Target enrolment
1
Study sites
Outside the US

What it is testing

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).

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • TASC-2 scale

    Measured over Three weeks after last PE

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

27 Years
Ages
All
Sex
Accepted
Healthy volunteers
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 * Woman of childbearing potential are required to use effective, established contraception, such as oral, injected or implanted hormonal methods of contraception, placement of an intrauterine device (IUD) or intrauterine system (IUS), barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository at least one month before and after each study substance intervention, and are willing to take a urine pregnancy test at the medical screening and before every study substance intervention. * Men are required to use contraceptive methods in the month after each study substance intervention and are required to inform their partner(s) about their study participation. 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. uncontrolled hypertension or hypotension) * Strong underweight (\<45kg) * Current major psychiatric disorder (including personality disorder, including 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. Patients must be willing to discontinue medications in cases where drug-related interactions are possible (the washout phase will be at least 5 times the particular drug's half-life \[typically 3-7 days\] prior to the respective study session). Discontinuation of medication must be judged to be acceptable by the responsible investigator. * Women are excluded from substance intervention during pregnancy or breastfeeding. * nParticipation in another clinical trial (currently or within the last 30 days)

Where

1 study site

FacilityCityRegionCountry
University Hospital BaselBaselSwitzerland

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT05570708 on ClinicalTrials.gov →

Last updated in the registry 2025-04-14. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits