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Effect of Ketanserin After LSD Administration (L-Ket)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04558294
Recruitment Status : Recruiting
First Posted : September 22, 2020
Last Update Posted : October 27, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Tracking Information
First Submitted Date  ICMJE August 25, 2020
First Posted Date  ICMJE September 22, 2020
Last Update Posted Date October 27, 2020
Actual Study Start Date  ICMJE October 16, 2020
Estimated Primary Completion Date October 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 21, 2020)
  • Duration of subjective response [ Time Frame: 12 months ]
    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.
  • Extent of subjective response [ Time Frame: 12 months ]
    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.
  • Plasma concentrations of LSD [ Time Frame: 12 months ]
    LSD plasma concentrations will be measured repeatedly over time using LC-MS/MS techniques (nanogram per milliliter scale).
  • Plasma concentrations of Ketanserin [ Time Frame: 12 months ]
    LSD plasma concentrations will be measured repeatedly over time using Liquid chromatography-mass spectrometry (LC-MS)/MS techniques (nanogram per milliliter scale).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2020)
  • 5 dimensions of altered state of consciousness (5D-ASC) profile total score [ Time Frame: 12 months ]
    Visual analog scale consisting of 94 items. Constructed of five scales and allows assessing mood, anxiety, derealization, depersonalization, changes in perception, auditory alterations, and reduced vigilance. Scales will be presented as 100 mm long horizontal lines marked with vertical lines by the participant.
  • Adjective mood rating scale (AMRS) [ Time Frame: 12 months ]
    The adjective mood rating scale (AMRS or EWL60S) is a 60-item 4-point Likert scale ("not at all", "somewhat", "rather", "strongly") that allows repeated assessment of mood in 6 dimensions: activation, inactivation, well-being, anxiety/depressed mood, extroversion and introversion, and emotional excitability.The AMRS consists of subscales measuring "activation", "positive mood", "extroversion", "introversion", "inactivation", and "emotional excitability".
  • States of consciousness questionnaire (SCQ) [ Time Frame: 12 months ]
    This 100-item questionnaire is rated on a 6-point scale (0=none, not at all; 1=so slight cannot decide; 2=slight; 3=moderate; 4=strong (equivalent in degree to any previous strong experience or expectation of this description); 5=extreme (more than ever before in my life and stronger than 4)). Forty-three items embedded into this questionnaire comprise the Mystical Experience Questionnaire (MEQ). The 43 items provide scale scores for each of seven domains of mystical experiences: internal unity (pure awareness, a merging with ultimate reality), external unity (unity of all things, all things are alive, all is one), sense of sacredness (reverence, sacred), noetic quality (encounter with ultimate reality, more real than everyday reality), transcendence of time and space, deeply felt positive mood (joy, peace, love), paradoxicality/ineffability (claim of difficulty in describing the experience in words).
  • Blood pressure [ Time Frame: 12 months ]
    Repeatedly measured using blood pressure / pulse apparatus (mmHg scale).
  • Heart rate [ Time Frame: 12 months ]
    Repeatedly measured using blood pressure / pulse apparatus (beats per minute scale).
  • Body temperature [ Time Frame: 12 months ]
    Repeatedly measured using ear thermometer (degree Celsius scale).
  • Pupil diameter [ Time Frame: 12 months ]
    Repeatedly measured using pupil distance meter (millimeter scale).
  • Elliot Humility Scale (EHS) [ Time Frame: 12 months ]
    Assesses the personality trait humility through 13 items on a 5-point Likert scale ranging from "strongly disagree" to "strongly agree".
  • Jankowski Humility Scale (JHS) [ Time Frame: 12 months ]
    Assesses the personality trait humility through 18 items on a 5-point Likert scale ranging from "not at all" to "strongly".
  • Arnett Inventory of Sensation Seeking (AISS-d) [ Time Frame: 12 months ]
    Assesses the personality trait of sensation seeking, which is is defined as a need for novel and intense stimulation. It uses 20 items using 4-point scales (1 = "describes me very well" to 4 = "does not describe me at all").
  • Freiburger Persönlichkeitsinventar (FPI) [ Time Frame: 12 months ]
    The FPI-R version comprises 138 items and covers 12 dimensions of personality: life satisfaction, social orientation, performance orientation, inhibition, excitability, aggressiveness, stress, physical complaints, health concerns, openness, as well as the secondary factors according to Eysenck's Extraversion and Emotionality (Neuroticism). It uses a 2-point scale ("true" and "not true").
  • Saarbrücker Persönlichkeitsfragebogen (SPF) [ Time Frame: 12 months ]
    The SPF defines empathy as the "reactions of one individual to the observed experiences of another." It assesses 28-items on a 5-point Likert scale ranging from "Does not describe me well" to "Describes me very well". The measure has 4 subscales (Perspective Taking, Fantasy, Empathic Concern, Personal Distress) each made up of 7 different items.
  • Defense Style Questionnaire (DSQ-40) [ Time Frame: 12 months ]
    The DSQ-40 can provide scores for 20 individual defenses, and scores for the three factors "mature", "neurotic", and "immature". Each item is evaluated on a scale from 1 to 9, where "1" indicates "completely disagree" and "9" indicates "fully agree".
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Ketanserin After LSD Administration
Official Title  ICMJE Effect of Ketanserin After LSD Administration on the Acute Response to LSD in Healthy Subjects
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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

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
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Lysergic Acid Diethylamide
    A moderate dose of 100 μg LSD will be administered.
    Other Name: LSD
  • Drug: Ketanserin Placebo
    Mannitol capsules instead of capsules containing Ketanserin.
  • Drug: Ketanserin
    A dose of 40 mg Ketanserin will be administered.
Study Arms  ICMJE
  • Experimental: 100 μg LSD + Ketanserin placebo
    Interventions:
    • Drug: Lysergic Acid Diethylamide
    • Drug: Ketanserin Placebo
  • Experimental: 100 μg LSD + Ketanserin (40mg)
    Interventions:
    • Drug: Lysergic Acid Diethylamide
    • Drug: Ketanserin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 21, 2020)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 1, 2021
Estimated Primary Completion Date October 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Matthias E Liechti, Dr., MD 061 328 68 68 ext +41 matthias.liechti@usb.ch
Contact: Anna Becker, MSc 061 328 68 61 ext +41 anna.becker@usb.ch
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04558294
Other Study ID Numbers  ICMJE BASEC 2020-00614
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Basel, Switzerland
Study Sponsor  ICMJE University Hospital, Basel, Switzerland
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Matthias E Liechti, Dr., MD University Hospital, Basel, Switzerland
PRS Account University Hospital, Basel, Switzerland
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP