Clinical trial NCT05570708: The Role of Personal Experience for the Therapeutic Attitude in the Context of Substance-assisted Therapy Training
Official title: The Role of Personal Experience for the Therapeutic Attitude in the Context of Substance-assisted Therapy Training
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Personal Experience of Substance-assisted Therapy Using Psilocybin, MDMA, and LSD
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Swiss Medical Society for Psycholytic Therapy
First posted: 2022-10-07
Enrollment: 48
Sex: ALL
Minimum age (years): 27
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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 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)

Primary outcomes:
measure: TASC-2 scale
timeFrame: Three weeks after last PE
Secondary outcomes:
measure: semi-structured interview
timeFrame: Five months after last PE
measure: TASC-2 scale
timeFrame: Three weeks after each PE and six months after last PE
measure: SOCS-S
timeFrame: Three weeks after each PE and six months after last PE
measure: SPCS-O
timeFrame: Three weeks after each PE and six months after last PE
measure: SPF/IRI
timeFrame: Three weeks after each PE and six months after last PE
measure: 5D-ASC
timeFrame: Directly after each PE
measure: CEQ
timeFrame: Directly after each PE
measure: APEQ
timeFrame: Directly after each PE
measure: PIQ
timeFrame: Directly after each PE
measure: CSOWD
timeFrame: Directly after each PE
measure: EBI
timeFrame: Directly after each PE
measure: BFW/E
timeFrame: Three weeks after each PE and six months after last PE
measure: PEQ
timeFrame: Three weeks after each PE and six months after last PE
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: University of Basel
name: Felix Müller, MD
role: PRINCIPAL_INVESTIGATOR
References: