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

Felix Mueller

Status

Invitation-only

Conditions

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

Treatments

Drug: MDMA, LSD, psilocybin

Study type

Interventional

Funder types

Other

Identifiers

NCT05570708

2022-01173

Details and patient eligibility

About

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).

Enrollment

48 estimated patients

Sex

All

Ages

27+ years old

Volunteers

Accepts 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)