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

NCT05570708 | Enrolling By Invitation DMC

• 1 other identifier: 2022-01173
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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).

Conditions

Personal Experience of Substance-assisted Therapy Using Psilocybin, MDMA, and LSD

Outcome Measures

Primary Outcomes (1)

• TASC-2 scale

  The primary endpoint is changes on the TASC-2 scale of the Therapeutic attitude questionnaire (ThAT)

  Three weeks after last PE

Secondary Outcomes (13)

• semi-structured interview

  Five months after last PE

• TASC-2 scale

  Three weeks after each PE and six months after last PE

• SOCS-S

  Three weeks after each PE and six months after last PE

• SPCS-O

  Three weeks after each PE and six months after last PE

• SPF/IRI

  Three weeks after each PE and six months after last PE

Study Arms (1)

Personal experience of substance-assisted therapy using psilocybin, MDMA, and LSD

EXPERIMENTAL

Drug: MDMA, LSD, psilocybin

Interventions

MDMA, LSD, psilocybin DRUG

* MDMA per os (2 x 100mg) in a group setting * LSD per os (75 and 150 mcg) in a 1:1 setting * Psilocybin per os (15 mg and 25 mg) in a group setting * Three study days are without drug administration: Participants experience the role of the therapist in a 1:1 setting

Personal experience of substance-assisted therapy using psilocybin, MDMA, and LSD

Eligibility Criteria

• Age: 27 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Felix Mueller: lead
• Swiss Medical Society for Psycholytic Therapy: collaborator

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Interventions

N-Methyl-3,4-methylenedioxyamphetamine; Lysergic Acid Diethylamide; Psilocybin

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals; Lysergic Acid; Ergolines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Tryptamines; Indolizidines; Indolizines

Study Officials

• Felix Müller, MD

  University of Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator PD Dr. med. Felix Müller MD

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: October 7, 2022
• Study Start: October 25, 2022
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: April 14, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)