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Role of the Serotonin 5-HT2A Receptor in LSD-induced Altered States of Consciousness (LDR-Study) (LDR)

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ClinicalTrials.gov Identifier: NCT03321136
Recruitment Status : Completed
First Posted : October 25, 2017
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Tracking Information
First Submitted Date  ICMJE September 8, 2017
First Posted Date  ICMJE October 25, 2017
Last Update Posted Date August 28, 2019
Actual Study Start Date  ICMJE November 28, 2017
Actual Primary Completion Date July 5, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 20, 2017)
Altered states of consciousness [ Time Frame: 18 months ]
total 5D-ASC score (5-Dimensional Altered States of Consciousness Rating Scale)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 20, 2017)
  • Subjective effects [ Time Frame: 18 months ]
    VAS (Visual analog scales)
  • Subjective effects [ Time Frame: 18 months ]
    AMRS scales (Adjective mood rating scale)
  • Psychotomimetic effects [ Time Frame: 18 months ]
    ESI scale (Eppendorf Schizophrenia Inventory)
  • Mystical-type experiences [ Time Frame: 18 months ]
    MS scales (Mysticism scale)
  • Mystical-type experiences [ Time Frame: 18 months ]
    SCQ scales (States of consciousness questionnaire)
  • Autonomic effects [ Time Frame: 18 months ]
    Blood pressure
  • Autonomic effects [ Time Frame: 18 months ]
    Heart Rate
  • Autonomic effects [ Time Frame: 18 months ]
    Body temperature
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 Role of the Serotonin 5-HT2A Receptor in LSD-induced Altered States of Consciousness (LDR-Study)
Official Title  ICMJE Role of the Serotonin 5-HT2A Receptor in LSD-induced Altered States of Consciousness (LDR-Study)
Brief Summary Serotonin receptors, especially the 5HT2A receptor, are thought to be involved in the effects of various recreationally used psychedelic substances such as LSD. LSD potently stimulates the 5-HT2A receptor but also 5-HT2B/C, 5-HT1 and dopaminergic receptors. LSD induces acute transient alterations in waking consciousness including visual perceptual alterations, audio-visual synesthesia, derealization and depersonalization. LSD has therefore been used as experimental tool ("psychotomimetic") in modern psychiatric research to study psychotic-like states and model psychosis in healthy subjects [1-5]. However, the dose-effects of 5-HT2A receptor stimulation by LSD has not yet been studied. Additionally, there is still very limited data to what extent the 5HT2A receptor contributes to LSD's effects and its role in the mediation of the full response to LSD at a high dose is unclear. A recent experimental human study showed the 5-HT2A receptor antagonist ketanserin fully blocked the subjective effects of a moderate dose of 100 µg of LSD [6]. But, whether the effects of a high 200 µg oral dose of LSD can be blocked by the selective pharmacological 5-HT2A antagonist ketanserin remains to be tested to confirm the critical role of the 5-HT2A receptor in more pronounced alterations of consciousness and perception. The present study therefore explores the role the 5-HT2A receptor in LSD-induced altered states of consciousness using escalating doses of LSD and the 5-HT2A receptor blocker ketanserin administered before a high dose of LSD.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: LSD
    0.025 mg LSD per os, single dose
    Other Name: Lysergic Acid Diethylamide
  • Drug: LSD
    0.05 mg LSD per os, single dose
    Other Name: Lysergic Acid Diethylamide
  • Drug: LSD
    0.1 mg LSD per os, single dose
    Other Name: Lysergic Acid Diethylamide
  • Drug: LSD
    0.2 mg LSD per os, single dose
    Other Name: Lysergic Acid Diethylamide
  • Drug: LSD
    0.2 mg LSD plus 40 mg ketanserin per os, single doses each
    Other Name: Lysergic Acid Diethylamide
  • Drug: Placebo
    Capsules containing mannitol looking identical to the other drugs.
Study Arms  ICMJE
  • Placebo Comparator: Placebo, LSD-25, LSD-50, LSD-100, LSD-200, LSD-200-Ketanserin
    Cross-over within-subjects design with all treatment conditions, separated by a wash-out phase
    Interventions:
    • Drug: LSD
    • Drug: LSD
    • Drug: LSD
    • Drug: LSD
    • Drug: LSD
    • Drug: Placebo
  • Placebo Comparator: LSD-25, LSD-50, LSD-100, LSD-200, LSD-200-Ketanserin, Placebo
    Cross-over within-subjects design with all treatment conditions, separated by a wash-out phase
    Interventions:
    • Drug: LSD
    • Drug: LSD
    • Drug: LSD
    • Drug: LSD
    • Drug: LSD
    • Drug: Placebo
  • Placebo Comparator: LSD-50, LSD-100, LSD-200, LSD-200-Ketanserin, Placebo, LSD-25
    Cross-over within-subjects design with all treatment conditions, separated by a wash-out phase
    Interventions:
    • Drug: LSD
    • Drug: LSD
    • Drug: LSD
    • Drug: LSD
    • Drug: LSD
    • Drug: Placebo
  • Placebo Comparator: LSD-100, LSD-200, LSD-200-Ketanserin, Placebo, LSD-25, LSD-50
    Cross-over within-subjects design with all treatment conditions, separated by a wash-out phase
    Interventions:
    • Drug: LSD
    • Drug: LSD
    • Drug: LSD
    • Drug: LSD
    • Drug: LSD
    • Drug: Placebo
  • Placebo Comparator: LSD-200, LSD-200-Ketanserin, Placebo, LSD-25, LSD-50, LSD-100
    Cross-over within-subjects design with all treatment conditions, separated by a wash-out phase
    Interventions:
    • Drug: LSD
    • Drug: LSD
    • Drug: LSD
    • Drug: LSD
    • Drug: LSD
    • Drug: Placebo
  • Placebo Comparator: LSD-200-Ketanserin, Placebo, LSD-25, LSD-50, LSD-100, LSD-200
    Cross-over within-subjects design with all treatment conditions, separated by a wash-out phase
    Interventions:
    • Drug: LSD
    • Drug: LSD
    • Drug: LSD
    • Drug: LSD
    • Drug: LSD
    • Drug: Placebo
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 Completed
Actual Enrollment  ICMJE
 (submitted: October 20, 2017)
16
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 11, 2019
Actual Primary Completion Date July 5, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age between 25 and 65 years.
  2. Understanding of the German language.
  3. Understanding the procedures and the risks associated with the study.
  4. Participants must be willing to adhere to the protocol and sign the consent form.
  5. Participants must be willing to refrain from taking illicit psychoactive substances during the study.
  6. Participants must be willing to drink only alcohol-free liquids and no coffee, black or green tea, or energy drink after midnight of the evening before the study session, as well as during the study day.
  7. Participants must be willing not to drive a traffic vehicle or to operate machines within 48 h after substance administration.
  8. Women of childbearing potential must have a negative pregnancy test at the beginning of the study. Pregnancy tests are repeated before each study session.
  9. Women of childbearing potential must be willing to use double-barrier birth control
  10. Body mass index 18-29 kg/m2.

Exclusion Criteria:

  1. Chronic or acute medical condition
  2. Current or previous major psychiatric disorder
  3. Psychotic disorder in first-degree relatives
  4. Illicit substance use (with the exception of cannabis) more than 10 times or any time within the previous two months.
  5. Pregnant or nursing women.
  6. Participation in another clinical trial (currently or within the last 30 days)
  7. Use of medications that may interfere with the effects of the study medications (any psychiatric medications)
  8. Tobacco smoking (>10 cigarettes/day)
  9. Consumption of alcoholic drinks (>10/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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03321136
Other Study ID Numbers  ICMJE BASEC-2017-01348
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
Plan to Share IPD: No
Responsible Party University Hospital, Basel, Switzerland
Study Sponsor  ICMJE University Hospital, Basel, Switzerland
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Matthias E Liechti, MD, MAS University Hospital, Basel, Switzerland
PRS Account University Hospital, Basel, Switzerland
Verification Date August 2019

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