Personal Experience of Substance-assisted Therapy Using Psilocybin, MDMA, and LSDTherPsySENCT05570708
The Role of Personal Experience for the Therapeutic Attitude in the Context of Substance-assisted Therapy Training
A study testing MDMA, LSD, psilocybin in people with Personal Experience of Substance-assisted Therapy Using Psilocybin, MDMA, and LSD, run by Felix Mueller at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 27 years and olderHealthy volunteers can take part
- Conditions the study is for
- Personal Experience of Substance-assisted Therapy Using Psilocybin, MDMA, and LSD
- What is being tested?
- MDMA, LSD, psilocybin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSwitzerland
- Study dates
- 25 Oct 2022to 1 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 27 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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).
- Being tested
- MDMA, LSD, psilocybin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MDMA, LSD, psilocybinDrug
- 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
| Study group | Role | What they receive |
|---|---|---|
| Personal experience of substance-assisted therapy using psilocybin, MDMA, and LSD | Experimental | Not described Receives: Drug: MDMA, LSD, psilocybin |
What is being measured
The primary outcome is the main question the study is designed to answer.
TASC-2 scale
The primary endpoint is changes on the TASC-2 scale of the Therapeutic attitude questionnaire (ThAT)
Measured: Three weeks after last PE
Secondary outcomes (13)
semi-structured interview
A semi-structured interview will be used to explore the range of effects and systematically collect and record subjective effects of the personal experience
Measured: Five months after last PE
TASC-2 scale
TASC-2 scale of the Therapeutic attitude questionnaire (ThAT)
Measured: Three weeks after each PE and six months after last PE
SOCS-S
Compassion with self
Measured: Three weeks after each PE and six months after last PE
SPCS-O
Compassion with others
Measured: Three weeks after each PE and six months after last PE
SPF/IRI
Empathy questionnaire
Measured: Three weeks after each PE and six months after last PE
5D-ASC
5 dimensions of altered states of consciousness questionnaire
Measured: Directly after each PE
CEQ
Challenging experience questionnaire
Measured: Directly after each PE
APEQ
Acceptance /avoidance-promoting experiences questionnaire
Measured: Directly after each PE
PIQ
Psychological insights questionnaire
Measured: Directly after each PE
CSOWD
Connectedness scale
Measured: Directly after each PE
EBI
Emotional breakthrough inventory
Measured: Directly after each PE
BFW/E
Berner Subjective Well-Being questionnaire
Measured: Three weeks after each PE and six months after last PE
PEQ
Persisting effects questionnaire
Measured: Three weeks after each PE and six months after last PE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start25 Oct 2022
- Primary completion1 Jun 2029 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Personal Experience of Substance-assisted Therapy Using Psilocybin, MDMA, and LSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Felix Mueller
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Medical Society for Psycholytic Therapy
- Responsible party
- Sponsor-investigator, Felix Mueller, University Hospital, Basel, Switzerland
- Investigators
- Felix Müller, MD, Principal investigator, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05570708
- Sponsor's protocol ID
- 2022-01173
- Acronym
- TherPsySE
- Status last verified
- Apr 2025
- First submitted
- 21 Sep 2022
- Last updated
- 14 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Personal Experience for the Therapeutic Attitude in the Context of Substance-assisted Therapy Training
- ClinicalTrials.gov ID
- NCT05570708
- Acronym / sponsor ID
- TherPsySE / 2022-01173
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Felix MuellerUniversity, hospital or other
- Collaborators
- Swiss Medical Society for Psycholytic Therapy
- Study start
- 25 Oct 2022 (actual)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 7 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Personal experience of substance-assisted therapy using psilocybin, MDMA, and LSD | Experimental | Drug: MDMA, LSD, psilocybin |
Who may qualify
- Ages
- 27 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MDMA, LSD, psilocybin* 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 | Drug | Personal experience of substance-assisted therapy using psilocybin, MDMA, and LSD |
Primary outcome
TASC-2 scale
Time frame: Three weeks after last PE
The primary endpoint is changes on the TASC-2 scale of the Therapeutic attitude questionnaire (ThAT)
13 secondary outcomes
semi-structured interview
Time frame: Five months after last PE
TASC-2 scale
Time frame: Three weeks after each PE and six months after last PE
SOCS-S
Time frame: Three weeks after each PE and six months after last PE
SPCS-O
Time frame: Three weeks after each PE and six months after last PE
SPF/IRI
Time frame: Three weeks after each PE and six months after last PE
5D-ASC
Time frame: Directly after each PE
CEQ
Time frame: Directly after each PE
APEQ
Time frame: Directly after each PE
PIQ
Time frame: Directly after each PE
CSOWD
Time frame: Directly after each PE
EBI
Time frame: Directly after each PE
BFW/E
Time frame: Three weeks after each PE and six months after last PE
PEQ
Time frame: Three weeks after each PE and six months after last PE
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Felix Müller, MD principal investigator
University of Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MDMA, LSD, psilocybin in people with Personal Experience of Substance-assisted Therapy Using Psilocybin, MDMA, and LSD, run by Felix Mueller at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 14 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TASC-2 scale (time frame: Three weeks after last PE). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2025.