Effects of medications on LSD responses in healthy individuals

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates whether administering ketanserin, olanzapine, and lorazepam after LSD can reduce and shorten the subjective effects of LSD compared to taking LSD alone. The research aims to provide insights into managing potential adverse psychological reactions to LSD, which is being explored for therapeutic use in various psychiatric and somatic disorders. Participants will receive different combinations of LSD and the medications to assess their effectiveness in altering the LSD experience. The study is conducted at the University Hospital Basel in Switzerland.

Why it matters

Who can join: the full rules

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 it's running

• University Hospital Basel
  Basel, Basel-Stadt, Switzerland Recruiting

Study contacts

• Study coordinator: Yasmin Schmid, Dr. med.
• Email: yasmin.schmid@usb.ch
• Phone: +41613286847

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.