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SNCTP000005586 | NCT05964647 | BASEC2023-01075

Effekte von Ketanserin, Olanzapin und Lorazepam nach der Verabreichung von Lysergsäurediethylamid (LSD) auf die akute Wirkung von LSD

Data source: BASEC (Imported from 26.12.2024), WHO (Imported from 19.12.2024)
Changed: Mar 14, 2024, 10:24 AM
Disease category: Other

Brief description of trial (Data source: BASEC)

In der Studie untersuchen wir, wie die psychedelischen Effekte von LSD von Ketanserin, Olanzapin und Lorazepam nachträglich beeinflusst werden. Die Hauptfrage, die die Studie beantworten will ist, ob sich die Wirkdauer und die subjektiven Effekte von LSD durch die spätere Verabreichung von Ketanserin, Olanzapin und Lorazepam (jeweils 1 Stunde nach der Verabreichung von LSD) verändert.

Health conditions investigated(Data source: BASEC)

Gesunde Versuchspersonen

Health conditions (Data source: WHO)

Healthy

Rare disease (Data source: BASEC)

No

Intervention investigated (e.g. drug, therapy or campaign) (Data source: BASEC)

Insgesamt dauert die Studie für Sie ca. 12-16 Wochen, und umfasst eine Eintrittsuntersuchung à 3h, fünf Studientage à je 25h, sowie eine Abschlussvisite à 1h.
An insgesamt fünf Studientagen werden Sie einmal LSD (150 µg) mit Placebo, einmal LSD (150 µg) mit Ketanserin (40 mg), einmal LSD (150 µg) mit Olanzapin (10 mg), einmal LSD (150 µg) mit Lorazepam (2 mg) und einmalig nur Placebo erhalten.
Nach Verabreichung der Substanzen werden Sie wiederholt gebeten, die erlebte Wirkung mittels Fragebögen zu beschreiben. Es werden regelmässig Blutdruck, Puls und Körpertemperatur gemessen, sowie Blut über einen Venenkatheter entnommen. An den Studientage wird ausserdem jeweils ein kurzer Schreckreflextest durchgeführt und die Schlafmuster werden überwacht. Sie werden an den fünf Studientagen im ambulanten Studienzentrum des Universitätsspitals Basel kontinuierlich betreut und können jeweils nach 25h wieder nach Hause gehen.
Es werden 20 gesunde Probanden:innen zwischen 25-65 Jahre eingeschlossen.

Interventions (Data source: WHO)

Drug: LSD (150 ?g) + ketanserin (40 mg);Drug: LSD (150 ?g) + olanzapine (10 mg);Drug: LSD (150 ?g) + lorazepam (2 mg);Drug: LSD (150 ?g) + placebo;Drug: Placebo + placebo

Criteria for participation in trial (Data source: BASEC)

- Sie sind körperlich und psychisch gesund und haben keine Verwandten ersten Grades, die an psychotischen oder bipolaren Erkrankungen leiden.
- Sie sind zwischen 25 und 65 Jahren alt.
- Sie sprechen fliessend Deutsch.

Exclusion criteria (Data source: BASEC)

-Sie sind stark über- oder untergewichtig sein (BMI unter 18 oder über 29 kg/m2)
-Sie leiden an Bluthochdruck
-Sie nehmen gleichzeitig an einer anderen klinischen Studie teil

Inclusion/Exclusion Criteria (Data source: WHO)

Gender: All
Maximum age: 65 Years
Minimum age: 25 Years

Inclusion Criteria:

1. Age between 25 and 65 years

2. Sufficient understanding of the German language

3. Understanding of procedures and risks associated with the study

4. Willing to adhere to the protocol and signing of the consent form

5. Willing to refrain from the consumption of illicit psychoactive substances during the
study

6. Abstaining from xanthine-based liquids and foods from the evenings prior to the study
sessions to the end of the study days, limit coffee drinking = 3 cups per day for 7
days prior to study day

7. Participants must be willing not to drive a traffic vehicle or to operate machines
within 48 h after substance administration

8. Willing to use effective contraceptive measures throughout study participation
(according to Clinical Trial Facilitation Group (CTFG): Recommendations related to
contraception and pregnancy testing in clinical trials)

9. Women of childbearing potential must have a negative pregnancy test at the beginning
of the study. Pregnancy tests are repeated before each study session.

10. Body mass index between 18 - 29 kg/m2

Exclusion Criteria:

1. Chronic or acute medical condition

2. Current or previous major psychiatric disorder including psychotic disorder, mania /
hypomania, borderline personality disorders.

3. Psychotic disorder or bipolar disorder in first-degree relatives

4. Known hypersensitivity to LSD, ketanserin, olanzapine or lorazepam

5. Hypertension (>140/90 mmHg) or hypotension (SBP < 85 mmHg)

6. Hallucinogenic substance use (not including cannabis) more than 10 times or any time
within the previous two months

7. Pregnancy or current breastfeeding

8. Participation in another clinical trial (currently or within the last 30 days)

9. Use of medication that may interfere with the effects of the study medication

10. Current substance use disorder (within the last 2 months)

11. Tobacco smoking (>1 cigarette/day)

12. Consumption of alcoholic beverages (>15 drinks/week)

13. Not exhibiting consistent startle responding on the screening day (i.e., over 75%
discernible responses to six 108 dB 40 ms startle pulses), as this would preclude the
ability to measure fear potentiated startle.

14. Use of strong CYP2D6 inhibitor

15. Use of strong CYP1A2 inhibitor or inducer

Further information on the trial in WHO primary registry

https://clinicaltrials.gov/ct2/show/NCT05964647

Further information on the trial from WHO database (ICTRP)

https://trialsearch.who.int/Trial2.aspx?TrialID=NCT05964647
Further information on trial

Recruitment status

Recruiting

Academic title (Data source: WHO)

Effect of Ketanserin, Olanzapine, and Lorazepam After LSD Administration on the Acute Response to LSD in Healthy Subjects

Type of trial (Data source: WHO)

Interventional

Design of the trial (Data source: WHO)

Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).

Phase (Data source: WHO)

Phase 1

Primary end point (Data source: WHO)

Duration of subjective response;Extent of subjective response

Secundary end point (Data source: WHO)

Alterations of consciousness;Mystical-type effects;Subjective effects I;Subjective effects II;Subjective effects III;Psychotomimetic effects I;Psychotomimetic effects II;Effects of LSD on mindfulness and decentering I;Effects of LSD on mindfulness and decentering II;Challenging experiences;Effects on prepulse inhibition and sensorimotor gating;Blood pressure;Heart rate;Body temperature;Pupil size;LSD concentrations in the blood;Ketanserin concentrations in the blood;Olanzapine concentrations in the blood;Lorazepam concentrations in the blood;Effects of LSD on sleep phases;Persisting effects;Adverse effects;Emotional effects;Sleepiness;Effect moderation through personality traits I;Effect moderation through personality traits II;Effect moderation through personality traits III;Effect moderation through personality traits IV;Effect moderation through personality traits V

Contact information (Data source: WHO)

Please refer to primary and secondary sponsors

Trial results (Data source: WHO)

Results summary

no information available yet

Link to the results in the primary register

no information available yet

Information on the availability of individual participant data

no information available yet

Trial sites

Trial sites in Switzerland (Data source: BASEC)

Basel

Countries (Data source: WHO)

Switzerland

Contact for further information on the trial

Details of contact in Switzerland (Data source: BASEC)

Yasmin Schmid
+41 61 328 68 47
yasmin.schmid@usb.ch

Contact for general information (Data source: WHO)

Yasmin Schmid, Dr. med.;Aaron Klaiber, MSc
+41613286847;+41613284567
yasmin.schmid@usb.ch;aaron.klaiber@usb.ch

Contact for scientific information (Data source: WHO)

Yasmin Schmid, Dr. med.;Aaron Klaiber, MSc
+41613286847;+41613284567
yasmin.schmid@usb.ch;aaron.klaiber@usb.ch

Authorisation by the ethics committee (Data source: BASEC)

Name of the authorising ethics committee (for multicentre studies only the lead committee)

Ethikkommission Nordwest- und Zentralschweiz EKNZ

Date of authorisation by the ethics committee

06.07.2023

Further trial identification numbers

Trial identification number of the ethics committee (BASEC-ID) (Data source: BASEC)

2023-01075

Secondary ID (Data source: WHO)

BASEC ID 2023-01075
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