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

Launched by UNIVERSITY HOSPITAL, BASEL, SWITZERLAND · Jul 19, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring how three medications—ketanserin, olanzapine, and lorazepam—affect the experience of LSD when given to healthy participants. Specifically, the researchers want to find out if these medications can reduce and shorten the effects of LSD, which is a powerful hallucinogenic drug. Participants will receive a dose of LSD and then the other medications to see if they help manage the effects better than just taking LSD alone.

To be eligible for the study, participants should be between 25 and 65 years old, understand German, and be in good health without major medical or psychiatric conditions. They should also be willing to follow certain guidelines, like avoiding certain foods and drinks before the study and not driving for 48 hours after taking the medications. If you join the study, you can expect to be closely monitored during the process, and you will need to sign a consent form to confirm your understanding of the study and its risks. This trial is currently looking for volunteers, and it aims to provide insights into managing the effects of hallucinogenic drugs.

Gender

ALL

Eligibility criteria

• 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