Effects of medications on LSD responses in healthy individuals
Effect of Ketanserin, Olanzapine, and Lorazepam After LSD Administration on the Acute Response to LSD in Healthy Subjects
This study is testing if giving certain medications after taking LSD can help lessen and shorten its effects in healthy people.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 25 Years to 65 Years |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 1 site (Basel, Basel-Stadt) |
| Trial ID | NCT05964647 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 25 to 65 who can understand German and are willing to comply with study protocols.
Not a fit: Patients with a history of psychiatric disorders or those currently taking psychoactive substances may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a pharmacological method to manage acute distress caused by LSD, enhancing safety in therapeutic settings.
How similar studies have performed: While the use of psychedelics in therapy is gaining attention, the specific combination of medications being tested in this study is novel and has not been extensively researched.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Basel, Basel-Stadt
- University Hospital Basel — Basel, Basel-Stadt, Switzerland (Recruiting)
Study contacts
- Study coordinator: Yasmin Schmid, Dr. med.
- Email: yasmin.schmid@usb.ch
- Phone: +41613286847
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.