The primary endpoint is changes on the TASC-2 scale of the Therapeutic attitude questionnaire (ThAT)
The Role of Personal Experience for the Therapeutic Attitude in the Context of Substance-assisted Therapy Training
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).
Intervention / Treatment
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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
Condition or Disease
- Personal Experience of Substance-assisted Therapy Using Psilocybin, MDMA, and LSD
Phase
Study Design
| Study type: | INTERVENTIONAL |
|---|---|
| Status: | Enrolling by invitation |
| Study results: | No Results Available |
| Enrollment: | 48 (ESTIMATED) |
| Allocation: | N/A |
| Primary Purpose: | Other |
Masking |
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Clinical Trial Dates
| Start date: | Oct 25, 2022 | ACTUAL |
|---|---|---|
| Primary Completion: | Jun 01, 2029 | ESTIMATED |
| Completion Date: | Jun 01, 2029 | ESTIMATED |
| Study First Posted: | Oct 07, 2022 | ACTUAL |
| Last Updated: | Feb 06, 2023 |
Sponsors / Collaborators
Lead Sponsor:
N/A
Responsible Party:
N/A
Participant Groups
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No description provided
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 27 |
| Age Groups: | Adult / Older Adult |
| Healthy Volunteers: | Yes |
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)
* 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
Secondary Outcomes
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A semi-structured interview will be used to explore the range of effects and systematically collect and record subjective effects of the personal experience
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TASC-2 scale of the Therapeutic attitude questionnaire (ThAT)
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Compassion with self
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Compassion with others
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Empathy questionnaire
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5 dimensions of altered states of consciousness questionnaire
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Challenging experience questionnaire
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Acceptance /avoidance-promoting experiences questionnaire
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Psychological insights questionnaire
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Connectedness scale
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Emotional breakthrough inventory
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Berner Subjective Well-Being questionnaire
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Persisting effects questionnaire
More Details
| NCT Number: | NCT05570708 |
|---|---|
| Other IDs: | 2022-01173 |
| Study URL: | https://clinicaltrials.gov/study/NCT05570708 |
Last updated: Sep 29, 2023