Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Direct Comparison of Altered States of Consciousness Induced by LSD and Psilocybin (LSD-psilo)

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: NCT03604744
Recruitment Status : Recruiting
First Posted : July 27, 2018
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Tracking Information
First Submitted Date  ICMJE July 19, 2018
First Posted Date  ICMJE July 27, 2018
Last Update Posted Date April 2, 2019
Actual Study Start Date  ICMJE March 27, 2019
Estimated Primary Completion Date April 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 26, 2018)
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 Complete list of historical versions of study NCT03604744 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2018)
  • Subjective effects assessed by VAS [ Time Frame: 18 Months ]
    VAS (Visual analog scale)
  • Subjective effects assessed by AMRS scales [ Time Frame: 18 Months ]
    AMRS scales (Adjective mood Rating scale)
  • Psychotomimetic effects [ Time Frame: 18 Months ]
    ESI (Eppendorf Schizophrenia Inventory)
  • Mystical-type experiences assessed by SCQ [ Time Frame: 18 Months ]
    SCQ (States of consciousness questionnaire)
  • Mystical-type experiences assessed by MS scales [ Time Frame: 18 Months ]
    MS scales (Mysticism scale)
  • Effects on emotion processing [ Time Frame: 18 Months ]
    FERT (Face Emotion Recognition Task)
  • Autonomic effects assessed by heart rate [ Time Frame: 18 Months ]
    Heart rate
  • Autonomic effects assessed by blood pressure [ Time Frame: 18 Months ]
    Blood pressure (diastolic and systolic)
  • Autonomic effects assessed by body temperature [ Time Frame: 18 Months ]
    Body temperature
Original Secondary Outcome Measures  ICMJE
 (submitted: July 26, 2018)
  • Subjective effects [ Time Frame: 18 Months ]
    VAS (Visual analog scale)
  • Subjective effects [ Time Frame: 18 Months ]
    AMRS scales (Adjective mood Rating scale)
  • Psychotomimetic effects [ Time Frame: 18 Months ]
    ESI (Eppendorf Schizophrenia Inventory
  • Mystical-type experiences [ Time Frame: 18 Months ]
    SCQ (States of consciousness questionnaire)
  • Mystical-type experiences [ Time Frame: 18 Months ]
    MS scales (Mysticism scale)
  • Effects on emotion processing [ Time Frame: 18 Months ]
    FERT (Face Emotion Recognition Task)
  • Autonomic effects [ Time Frame: 18 Months ]
    Heart rate
  • Autonomic effects [ Time Frame: 18 Months ]
    Blood pressure
  • Autonomic effects [ Time Frame: 18 Months ]
    Body temperature
Current Other Pre-specified Outcome Measures
 (submitted: August 8, 2018)
Plasma levels of LSD and psilocin [ Time Frame: 18 Months ]
assessment of plasma levels of LSD and psilocin
Original Other Pre-specified Outcome Measures
 (submitted: July 26, 2018)
Plasma levels of LSD and psilocin [ Time Frame: 18 Months ]
 
Descriptive Information
Brief Title  ICMJE Direct Comparison of Altered States of Consciousness Induced by LSD and Psilocybin
Official Title  ICMJE Direct Comparison of Altered States of Consciousness Induced by LSD and Psilocybin in a Random-order Placebo-controlled Cross-over Study in Healthy Subjects
Brief Summary LSD (lysergic acid diethylamide) and psilocybin (the active substance in "magic mushrooms") are widely used for recreational purposes. Both substances are also increasingly used in psychiatric and psychological research to induce and investigate alterations in waking consciousness and associated brain functions (functional brain imaging, "model psychosis") . However, it has never been studied whether there are differences in the alterations in mind produced by these two substances. Both LSD and psilocybin are thought to induce hallucinations primarily via stimulation of the 5-HT2A receptor. However, there are differences in the receptor activation profiles between the two substances that may also induce different subjective effects. LSD potently stimulates the 5-HT2A receptor but also 5-HT2B/C, 5-HT1 and D1-3 receptors . Psilocin (the active metabolite of the prodrug psilocybin) also stimulates the 5-HT2A receptor but additionally inhibits the 5-HT transporter. In contrast to LSD, psilocybin has no affinity for D2 receptors. Both substances are used in neuroscience as pharmacological tools. However, there are no modern studies comparing these two substances directly within the same clinical study and research subjects and using validated psychometric tools. Therefore, the investigators will compare the acute effects of LSD, psilocybin and placebo.
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
    LSD 0.1 mg per os, single dose
  • Drug: LSD
    LSD 0.2 mg per os, single dose
  • Drug: Psilocybin
    Psilocybin 15 mg per os, single dose
  • Drug: Psilocybin
    Psilocybin 30 mg per os, single dose
Study Arms  ICMJE
  • Experimental: LSD-100, LSD-200, Psilocybin-15, Psilocybin-30, Placebo
    Cross-over within-subjects design with all treatment conditions, separated by a wash-out phase
    Interventions:
    • Drug: LSD
    • Drug: LSD
    • Drug: Psilocybin
    • Drug: Psilocybin
  • Placebo Comparator: LSD-200, Psilocybin-15, Psilocybin-30, Placebo, LSD-100
    Cross-over within-subjects design with all treatment conditions, separated by a wash-out phase
    Interventions:
    • Drug: LSD
    • Drug: LSD
    • Drug: Psilocybin
    • Drug: Psilocybin
  • Placebo Comparator: Psilocybin-15, Psilocybin-30, Placebo, 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: Psilocybin
    • Drug: Psilocybin
  • Placebo Comparator: Psilocybin-30, Placebo, LSD-100, LSD-200, Psilocybin-15
    Cross-over within-subjects design with all treatment conditions, separated by a wash-out phase
    Interventions:
    • Drug: LSD
    • Drug: LSD
    • Drug: Psilocybin
    • Drug: Psilocybin
  • Placebo Comparator: Placebo, LSD-100, LSD-200, Psilocybin-15, Psilocybin-30
    Cross-over within-subjects design with all treatment conditions, separated by a wash-out phase
    Interventions:
    • Drug: LSD
    • Drug: LSD
    • Drug: Psilocybin
    • Drug: Psilocybin
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: July 26, 2018)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 1, 2020
Estimated Primary Completion Date April 1, 2020   (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 that are 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)
  10. Bodyweight < 50 kg
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, MD, MAS 61 328 68 68 ext +41 matthias.liechti@usb.ch
Contact: Friederike Holze, MSc 61 556 54 37 ext +41 friederike.holze@usb.ch
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03604744
Other Study ID Numbers  ICMJE BASEC 2018-00985
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: Undecided
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 March 2019

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