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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 : Recruiting
First Posted : October 25, 2017
Last Update Posted : December 12, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: LSD Drug: Placebo Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Role of the Serotonin 5-HT2A Receptor in LSD-induced Altered States of Consciousness (LDR-Study)
Actual Study Start Date : November 28, 2017
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Serotonin

Arm Intervention/treatment
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
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.

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
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.

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
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.

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
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.

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
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.

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
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.




Primary Outcome Measures :
  1. Altered states of consciousness [ Time Frame: 18 months ]
    total 5D-ASC score (5-Dimensional Altered States of Consciousness Rating Scale)


Secondary Outcome Measures :
  1. Subjective effects [ Time Frame: 18 months ]
    VAS (Visual analog scales)

  2. Subjective effects [ Time Frame: 18 months ]
    AMRS scales (Adjective mood rating scale)

  3. Psychotomimetic effects [ Time Frame: 18 months ]
    ESI scale (Eppendorf Schizophrenia Inventory)

  4. Mystical-type experiences [ Time Frame: 18 months ]
    MS scales (Mysticism scale)

  5. Mystical-type experiences [ Time Frame: 18 months ]
    SCQ scales (States of consciousness questionnaire)

  6. Autonomic effects [ Time Frame: 18 months ]
    Blood pressure

  7. Autonomic effects [ Time Frame: 18 months ]
    Heart Rate

  8. Autonomic effects [ Time Frame: 18 months ]
    Body temperature



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03321136


Contacts
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Contact: Matthias E Liechti, MD, MAS 61 328 68 68 ext +41 matthias.liechti@usb.ch
Contact: Friederike Holze, MSc 61 328 68 61 ext +41 friederike.holze@usb.ch

Locations
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Switzerland
University Hospital Recruiting
Basel, Switzerland, 4031
Contact: Matthias E Liechti, Prof. Dr. med.       matthias.liechti@usb.ch   
Contact: Friederike Holze, MSc       friederike.holze@usb.ch   
Sponsors and Collaborators
University Hospital, Basel, Switzerland

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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03321136     History of Changes
Other Study ID Numbers: BASEC-2017-01348
First Posted: October 25, 2017    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Serotonin
Lysergic Acid Diethylamide
Ketanserin
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antihypertensive Agents
Platelet Aggregation Inhibitors
Serotonin Antagonists
Hallucinogens
Psychotropic Drugs