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CompletedPhase 1

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

NCT05964647 · LBL · University Hospital, Basel, Switzerland

Closed to entry
Status
Not accepting participants
Phase 1
Phase
20
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

The main objective of this study is to determine whether administration of ketanserin (40 mg), olanzapine (10 mg), and lorazepam (2 mg) after administration of LSD (150 µg) attenuates and shortens the subjective LSD response (any drug effect) compared to administration of LSD (150 µg) alone

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Duration of subjective response

    Measured over 18 months

  • Extent of subjective response

    Measured over 18 months

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

25 Years to 65 Years
Ages
All
Sex
Accepted
Healthy volunteers
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

Where

1 study site

FacilityCityRegionCountry
University Hospital BaselBaselCanton of Basel-CitySwitzerland

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT05964647 on ClinicalTrials.gov →

Last updated in the registry 2025-11-17. Registry records change; this page reflects the data build of 2026-08-25.

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Where this trial sits