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Effect of Ketanserin After LSD Administration

NCT ID: NCT04558294

Last Updated: 2021-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-16

Study Completion Date

2021-09-29

Brief Summary

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LSD (lysergic acid diethylamide) is a serotonergic (5-HT) hallucinogen widely used for recreational and/or ethnomedical purposes. LSD is thought to induce its prototypical psychedelic effects primarily via stimulation of the 5-HT2A receptor. This study investigates whether an LSD experience can be attenuated and shortened using 5-HT2A receptor antagonist ketanserin administration after LSD once the psychedelic effects have established.

Detailed Description

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LSD is a so-called "classic" or serotonergic hallucinogen or psychedelic.The effects of LSD have been frequently investigated in the past in both healthy participants and patients. In these studies, LSD produced acute transient alterations in waking consciousness including visual perceptual alterations, audio-visual synesthesia, derealization and depersonalization. Moreover, several of these studies described robust and sustained effects of LSD in patients suffering from addiction, anxiety and depression.

Its psychedelic effects are mainly attributed to its potent partial 5-HT2A receptor agonism. Consistently, administration the 5-HT2A receptor antagonist ketanserin (40 mg) prior to the administration of LSD (100 μg) almost completely prevented the acute effects of LSD in another study of our research group (NCT03321136). The present study hypothesis is that ketanserin (40 mg) administered 1h after LSD shortens and reduces the acute subjective effects of LSD (100 μg) compared to LSD alone (100 μg) followed by placebo in healthy humans. Such a finding would confirm a primarily competitive antagonism of ketanserin and LSD at the 5-HT2A receptor in vivo and indicate that LSD produces its psychedelic effects only when present at the receptor.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Double-blind, placebo-controlled, random-order 2-period cross-over design with 2 treatment conditions:

1. 100 μg LSD + ketanserin (40 mg)
2. 100 μg LSD + placebo
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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100 μg LSD + Ketanserin placebo

Group Type EXPERIMENTAL

Lysergic Acid Diethylamide

Intervention Type DRUG

A moderate dose of 100 μg LSD will be administered.

Ketanserin Placebo

Intervention Type DRUG

Mannitol capsules instead of capsules containing Ketanserin.

100 μg LSD + Ketanserin (40mg)

Group Type EXPERIMENTAL

Lysergic Acid Diethylamide

Intervention Type DRUG

A moderate dose of 100 μg LSD will be administered.

Ketanserin

Intervention Type DRUG

A dose of 40 mg Ketanserin will be administered.

Interventions

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Lysergic Acid Diethylamide

A moderate dose of 100 μg LSD will be administered.

Intervention Type DRUG

Ketanserin Placebo

Mannitol capsules instead of capsules containing Ketanserin.

Intervention Type DRUG

Ketanserin

A dose of 40 mg Ketanserin will be administered.

Intervention Type DRUG

Other Intervention Names

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LSD

Eligibility Criteria

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Inclusion Criteria

1. Age between 25 and 65 years old
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
7. Willing not to operate heavy machinery within 48 hours after substance administration
8. Willing to use double-barrier birth control throughout study participation
9. Body mass index between 18-29 kg/m2

Exclusion Criteria

1. Chronic or acute medical condition
2. Current or previous major psychiatric disorder
3. Psychotic disorder or bipolar disorder in first-degree relatives
4. Hypertension (\>140/90 mmHg) or hypotension (SBP\<85 mmHg)
5. Hallucinogenic substance use (not including cannabis) more than 20 times or any time within the previous two months
6. Pregnancy or current breastfeeding
7. Participation in another clinical trial (currently or within the last 30 days)
8. Use of medication that may interfere with the effects of the study medication
9. Tobacco smoking (\>10 cigarettes/day)
10. Consumption of alcoholic beverages (\>20 drinks/week)
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthias E Liechti, Dr., MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

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Clinical Pharmacology & Toxicology, University Hospital Basel

Basel, , Switzerland

Site Status

Countries

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Switzerland

References

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Becker AM, Klaiber A, Holze F, Istampoulouoglou I, Duthaler U, Varghese N, Eckert A, Liechti ME. Ketanserin Reverses the Acute Response to LSD in a Randomized, Double-Blind, Placebo-Controlled, Crossover Study in Healthy Participants. Int J Neuropsychopharmacol. 2023 Feb 14;26(2):97-106. doi: 10.1093/ijnp/pyac075.

Reference Type DERIVED
PMID: 36342343 (View on PubMed)

Other Identifiers

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BASEC 2020-00614

Identifier Type: -

Identifier Source: org_study_id