Influence of self-experience on the therapeutic attitude of participants in a training for substance-assisted therapy

Switzerland (ICTRP)

ID di studio ICTRP
NCT05570708 (ICTRP)

Titolo ufficiale (approvato dal comitato etico)
The role of personal experience for the therapeutic attitude in the context of substance-assisted therapy training (BASEC)

Titolo accademico
The Role of Personal Experience for the Therapeutic Attitude in the Context of Substance-assisted Therapy Training (ICTRP)

Titolo pubblico
The Role of Personal Experience for the Therapeutic Attitude in the Context of Substance-assisted Therapy Training (ICTRP)

Malattie studiate
Personal Experience of Substance-assisted Therapy Using Psilocybin, MDMA, and LSD (ICTRP)

Intervento studiato
Drug: MDMA, LSD, psilocybin (ICTRP)

Tipo di studio
Interventional (ICTRP)

Disegno dello studio
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label). (ICTRP)

Criteri di inclusione/esclusione
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)

non disponibile

Endpoint primari e secondari
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)

Data di registrazione
non disponibile

Inclusione del primo partecipante
non disponibile

Sponsor secondari
Swiss Medical Society for Psycholytic Therapy (ICTRP)

Contatti aggiuntivi
Felix Mller, MD, University of Basel (ICTRP)

ID secondari
2022-01173 (ICTRP)

Risultati-Dati individuali dei partecipanti
non disponibile

Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT05570708 (ICTRP)