Effect of Ketanserin After LSD Administration

NCT04558294 | Completed Phase 1 DMC

• 1 other identifier: BASEC 2020-00614
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Duration of subjective response

  Visual Analog Scales (VAS) will be repeatedly used to assess subjective alterations in consciousness over time. VAS will be presented as 100 mm long horizontal lines marked with "not at all" on the left and "extremely" on the right. The following VAS will be used: "any effect", "good effect", "bad effect", "fear", "stimulated", "nausea", "tiredness", "alteration of hearing", "alteration of vision", "synesthesia", "alteration in sense of time", "the boundaries between myself and my surroundings seemed to blur", "talkative", "open", "trust" and "my focus is directed: outward/inward". Subjects will mark the scale with vertical lines.

  12 months

• Extent of subjective response

  Visual Analog Scales (VAS) will be repeatedly used to assess subjective alterations in consciousness over time. VAS will be presented as 100 mm long horizontal lines marked with "not at all" on the left and "extremely" on the right. The following VAS will be used: "any effect", "good effect", "bad effect", "fear", "stimulated", "nausea", "tiredness", "alteration of hearing", "alteration of vision", "synesthesia", "alteration in sense of time", "the boundaries between myself and my surroundings seemed to blur", "talkative", "open", "trust" and "my focus is directed: outward/inward". Subjects will mark the scale with vertical lines.

  12 months

• Plasma concentrations of LSD

  LSD plasma concentrations will be measured repeatedly over time using LC-MS/MS techniques (nanogram per milliliter scale).

  12 months

• Plasma concentrations of Ketanserin

  LSD plasma concentrations will be measured repeatedly over time using Liquid chromatography-mass spectrometry (LC-MS)/MS techniques (nanogram per milliliter scale).

  12 months

Secondary Outcomes (13)

• 5 dimensions of altered state of consciousness (5D-ASC) profile total score

  12 months

• Adjective mood rating scale (AMRS)

  12 months

• States of consciousness questionnaire (SCQ)

  12 months

• Blood pressure

  12 months

• Heart rate

  12 months

Study Arms (2)

100 μg LSD + Ketanserin placebo

EXPERIMENTAL

Drug: Lysergic Acid Diethylamide; Drug: Ketanserin Placebo

100 μg LSD + Ketanserin (40mg)

EXPERIMENTAL

Drug: Lysergic Acid Diethylamide; Drug: Ketanserin

Interventions

Lysergic Acid Diethylamide DRUG

A moderate dose of 100 μg LSD will be administered.

Also known as: LSD

100 μg LSD + Ketanserin (40mg); 100 μg LSD + Ketanserin placebo

Ketanserin Placebo DRUG

Mannitol capsules instead of capsules containing Ketanserin.

100 μg LSD + Ketanserin placebo

Ketanserin DRUG

A dose of 40 mg Ketanserin will be administered.

100 μg LSD + Ketanserin (40mg)

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 25 and 65 years old
• Sufficient understanding of the German language
• Understanding of procedures and risks associated with the study
• Willing to adhere to the protocol and signing of the consent form
• Willing to refrain from the consumption of illicit psychoactive substances during the study
• Abstaining from xanthine-based liquids and foods from the evenings prior to the study sessions to the end of the study days
• Willing not to operate heavy machinery within 48 hours after substance administration
• Willing to use double-barrier birth control throughout study participation
• Body mass index between 18-29 kg/m2

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Clinical Pharmacology & Toxicology, University Hospital Basel

Basel, 4031, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 36342343 DERIVED

MeSH Terms

Interventions

Lysergic Acid Diethylamide; Ketanserin

Intervention Hierarchy (Ancestors)

Lysergic Acid; Ergolines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Piperidines; Heterocyclic Compounds, 1-Ring; Quinazolinones; Quinazolines; Heterocyclic Compounds, 2-Ring

Study Officials

• Matthias E Liechti, Dr., MD

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: August 25, 2020
• First Posted: September 22, 2020
• Study Start: October 16, 2020
• Primary Completion: August 28, 2021
• Study Completion: September 29, 2021
• Last Updated: October 21, 2021

Record last verified: 2021-10

Locations

CH (1)