Influence of self-experience on the therapeutic attitude of participants in a training for substance-assisted therapy
Summary description of the study
Therapeutic self-experience is a mandatory and integral part of most training programs for psychotherapists and psychiatrists. Among other things, it has been shown that self-experience improves the self-perception of psychotherapeutic processes, the methodological competence of therapists, as well as their sensitivity and empathy towards their patients. Currently, a training program for substance-assisted therapy is offered in Switzerland. In this approach, psychoactive substances such as LSD, psilocybin, and MDMA are used to treat mental illnesses such as depression and anxiety. It has not yet been systematically investigated whether self-experience is also relevant within the framework of substance-assisted therapy. The aim of this study is to fill this research gap by examining the subjective effects of psychedelic self-experience on the therapeutic attitude, subjective empathy with patients, expectations of psychedelic-assisted therapy, and the perceived risks and benefits of self-experience.
(BASEC)
Intervention under investigation
The following conditions will be investigated:
- Group setting with intake of 100 mg MDMA
- Intake of 100 mg MDMA in a 1:1 setting
- Care of a person after intake of 100 mg MDMA in a 1:1 setting
- Intake of 75 mcg LSD in a 1:1 setting
- Intake of 150 mcg LSD in a 1:1 setting
- Care of a person after intake of 75 mcg LSD in a 1:1 setting
- Care of a person after intake of 150 mcg LSD in a 1:1 setting
- Group setting with intake of 15 mg psilocybin
- Group setting with intake of 25 mg psilocybin
(BASEC)
Disease under investigation
Self-experience in substance-assisted therapy with LSD, psilocybin, and MDMA
(BASEC)
Candidates from the training of the Swiss Medical Society for Psycholytic Therapy can participate in this study. (BASEC)
Exclusion criteria
Individuals must not have a history of psychotic illness (e.g., schizophrenia) or bipolar disorder. Additionally, such illnesses must not exist in first-degree relatives. Another exclusion criterion is an existing suicide risk. (BASEC)
Trial sites
Basel
(BASEC)
Sponsor
PD Dr. med. Felix Müller Division of Clinical Pharmacology and Toxicology University Hospital Basel Schanzentrasse 55 CH-4031 Basel Phone: +41 61 325 5394 Email: felix.mueller@usb.ch
(BASEC)
Contact
Contact Person Switzerland
PD Dr. med. Felix Müller
061 325 5111
felix.mueller@clutterusb.chDivision of Clinical Pharmacology and Toxicology University Hospital Basel Schanzentrasse 55 CH-4031 Basel
(BASEC)
General Information
University of Basel
(ICTRP)
Scientific Information
University of Basel
(ICTRP)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee northwest/central Switzerland EKNZ
(BASEC)
Date of authorisation
25.10.2022
(BASEC)
ICTRP Trial ID
NCT05570708 (ICTRP)
Official title (approved by ethics committee)
The role of personal experience for the therapeutic attitude in the context of substance-assisted therapy training (BASEC)
Academic title
The Role of Personal Experience for the Therapeutic Attitude in the Context of Substance-assisted Therapy Training (ICTRP)
Public title
The Role of Personal Experience for the Therapeutic Attitude in the Context of Substance-assisted Therapy Training (ICTRP)
Disease under investigation
Personal Experience of Substance-assisted Therapy Using Psilocybin, MDMA, and LSD (ICTRP)
Intervention under investigation
Drug: MDMA, LSD, psilocybin (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label). (ICTRP)
Inclusion/Exclusion criteria
Inclusion Criteria:
- Participation in the SPT 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) (ICTRP)
not available
Primary and secondary end points
TASC-2 scale (ICTRP)
semi-structured interview;TASC-2 scale;SOCS-S;SPCS-O;SPF/IRI;5D-ASC;CEQ;APEQ;PIQ;CSOWD;EBI;BFW/E;PEQ (ICTRP)
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
Swiss Medical Society for Psycholytic Therapy (ICTRP)
Additional contacts
Felix Mller, MD, University of Basel (ICTRP)
Secondary trial IDs
2022-01173 (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT05570708 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available