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Effects of Dimethyltryptamine in Healthy Subjects (DMT)

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ClinicalTrials.gov Identifier: NCT04353024
Recruitment Status : Not yet recruiting
First Posted : April 20, 2020
Last Update Posted : February 2, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Tracking Information
First Submitted Date  ICMJE April 6, 2020
First Posted Date  ICMJE April 20, 2020
Last Update Posted Date February 2, 2021
Estimated Study Start Date  ICMJE July 1, 2021
Estimated Primary Completion Date July 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2020)
  • Altered states of consciousness profile [ Time Frame: 150 minutes ]
    Assessed once on each study day via 5 Dimensions of Altered States of Consciousness (5D-ASC) scale consisting of 94 items to be rated on a visual analog scale (0-100 mm), with higher values indicating stronger effects
  • Subjective effect ratings over time [ Time Frame: 150 minutes ]
    Assessed 22 times on each study day via Subjective Effect Scale (SES), consisting of 4 questions to be rated on a Likert scale ranging from 1 to 10, with higher ratings indicating stronger effects
Original Primary Outcome Measures  ICMJE
 (submitted: April 15, 2020)
  • Altered states of consciousness profile [ Time Frame: 150 minutes ]
    Assessed once on each study day via 5 Dimensions of Altered States of Consciousness (5D-ASC) scale consisting of 94 items to be rated on a visual analog scale of 100 mm
  • Subjective effect ratings over time [ Time Frame: 150 minutes ]
    Assessed 22 times on each study day via Subjective Effect Scale (SES), consisting of 4 questions to be rated on a scale from 1 to 10
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2020)
  • Subjective mood ratings [ Time Frame: 150 minutes ]
    Assessed twice on each study day via the Adjective Mood Rating Scale (AMRS) consisting of 60 items to be rated on a 4-point Likert scale, with higher ratings indicating stronger identification with the specific mood
  • Mystical-type experiences [ Time Frame: 150 minutes ]
    Assessed once on each study day via States of Consciousness Questionnaire (SCQ) which measures the emergence and intensity of phenomenons occurring in altered states of consciousness on a 6-point Likert scale ranging from 0 ("not at all") to 5 ("extremely")
  • Autonomic effects I [ Time Frame: 150 minutes ]
    Assessed 22 times on each study day via systolic and diastolic blood pressure, Emax
  • Autonomic effects II [ Time Frame: 150 minutes ]
    Assessed 22 times on each study day via heart rate, Emax
  • Plasma levels of DMT [ Time Frame: 150 minutes ]
    Assessed 21 times on each study day via blood samples
  • Plasma levels of blood-derived neurotrophic factor (BDNF) [ Time Frame: 150 minutes ]
    Assessed 21 times on each study day via blood samples
  • Plasma levels of oxytocin [ Time Frame: 60 minutes ]
    Assessed twice on each study day via blood samples
  • Renal clearance of DMT [ Time Frame: 3 hours ]
    Collected once per study day via one-time interval urine recovery
  • Effect moderation through personality traits I [ Time Frame: Baseline ]
    Assessed via NEO-Five-Factor-Inventory (NEO-FFI)
  • Effect moderation through personality traits II [ Time Frame: Baseline ]
    Assessed via Freiburger Personality Inventory (FPI)
  • Effect moderation through personality traits III [ Time Frame: Baseline ]
    Assessed via Saarbrücker Personality Questionnaire (SPF)
  • Effect moderation through personality trait IV [ Time Frame: Baseline ]
    Assessed via Elliot Humility Scale (EHS) which measures the personality trait humility through 13 items on a 5-point Likert scale ranging from "strongly disagree" to "strongly agree"
  • Effect moderation through personality trait V [ Time Frame: Baseline ]
    Assessed via Jankowski Humility Scale (JHS) which measures the personality trait humility through 18 items on a 5-point Likert scale ranging from "not at all" to "strongly"
  • Effect moderation through personality trait VI [ Time Frame: Baseline ]
    Assessed via Arnett Inventory of Sensation Seeking (AISS-d)
  • Effect moderation through personality trait VII [ Time Frame: Baseline ]
    Assessed via Defense Style Questionnaire (DSQ-40)
  • Adverse effects [ Time Frame: 150 minutes ]
    Assessed via the List of Complaints (LC) which covers the emergence of 66 complaints in a yes/no format
Original Secondary Outcome Measures  ICMJE
 (submitted: April 15, 2020)
  • Subjective mood ratings [ Time Frame: 150 minutes ]
    Assessed twice on each study day via Adjective Mood Rating Scale (AMRS)
  • Mystical-type experiences [ Time Frame: 150 minutes ]
    Assessed once on each study day via States of Consciousness Questionnaire (SCQ) which measures the emergence and intensity of phenomenons occurring in altered states of consciousness on a 6-point Likert scale ranging from 0 ("not at all") to 5 ("extremely")
  • Autonomic effects I [ Time Frame: 150 minutes ]
    Assessed 22 times on each study day via blood pressure, Emax
  • Autonomic effects II [ Time Frame: 150 minutes ]
    Assessed 22 times on each study day via heart rate, Emax
  • Plasma levels of DMT [ Time Frame: 150 minutes ]
    Assessed 21 times on each study day via blood samples
  • Plasma levels of blood-derived neurotrophic factor (BDNF) [ Time Frame: 150 minutes ]
    Assessed 21 times on each study day via blood samples
  • Plasma levels of oxytocin [ Time Frame: 60 minutes ]
    Assessed twice on each study day via blood samples
  • Renal clearance of DMT [ Time Frame: 3 hours ]
    Collected once per study day via one-time interval urine recovery
  • Effect moderation through personality traits I [ Time Frame: Baseline ]
    Assessed via NEO-Five-Factor-Inventory (NEO-FFI)
  • Effect moderation through personality traits II [ Time Frame: Baseline ]
    Assessed via Freiburger Personality Inventory (FPI)
  • Effect moderation through personality traits III [ Time Frame: Baseline ]
    Assessed via Saarbrücker Personality Questionnaire (SPF)
  • Effect moderation through personality trait IV [ Time Frame: Baseline ]
    Assessed via Elliot Humility Scale (EHS) which measures the personality trait humility through 13 items on a 5-point Likert scale ranging from "strongly disagree" to "strongly agree"
  • Effect moderation through personality trait V [ Time Frame: Baseline ]
    Assessed via Jankowski Humility Scale (JHS) which measures the personality trait humility through 18 items on a 5-point Likert scale ranging from "not at all" to "strongly"
  • Effect moderation through personality trait VI [ Time Frame: Baseline ]
    Assessed via Arnett Inventory of Sensation Seeking (AISS-d)
  • Effect moderation through personality trait VII [ Time Frame: Baseline ]
    Assessed via Defense Style Questionnaire (DSQ-40)
  • Adverse effects [ Time Frame: 150 minutes ]
    Assessed via the List of Complaints (LC) which covers the emergence of 66 complaints in a yes/no format
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Dimethyltryptamine in Healthy Subjects
Official Title  ICMJE Effects of Dimethyltryptamine (DMT) in Healthy Subjects: A Placebo-controlled Cross-over Study
Brief Summary N,N-dimethyltryptamine (DMT) is a naturally-occurring psychedelic substance widely used in recreational and spiritual settings. DMT can be used as a tool to induce an altered state of consciousness of interest in psychological and psychiatric research. DMT is rapidly metabolized by monoamine oxidase (MAO) A. Therefore, it is inactive when administered orally and has a very short duration of action when administered parenterally (<20 min).Therefore, an intravenous administration regime including a bolus and maintenance perfusion has been proposed to induce a stable and prolonged DMT experience allowing to study the psychological and autonomic acute effects of DMT. This administration allows to induce and end an altered state safely and quickly. The goal of the present study is to experimentally test different intravenous DMT administration schedules to investigate the subjective and autonomic effects of DMT in healthy subjects.
Detailed Description N,N-dimethyltryptamine (DMT) is a naturally-occurring psychedelic substance widely used in recreational and spiritual settings in the form of Ayahuasca. Similar to lysergic acid diethylamide (LSD) or psilocybin, DMT is considered a tool to induce an altered state of consciousness of interest in psychological and psychiatric research. Pharmacologically, DMT interacts with the serotonin 5-HT2A receptor similar to other classic hallucinogens including LSD and psilocybin. The main difference of DMT in comparison with LSD or psilocybin is inactivity when administered orally without monoamine oxidase (MAO) A inhibition and its short action when administered intravenously or by inhalation. In Ayahuasca, DMT is consumed iin combination with harmala alkaloids that inhibit MAO to increase the oral bioavailability of DMT and to prolong its action after oral use. Alternatively, an intravenous administration regime including a bolus and a one hour maintenance perfusion has been proposed to induce a stable and prolonged DMT experience, allowing to study the psychological and autonomic acute effects of DMT. Also, the maintenance perfusion administration allows to end an altered state of consciousness quickly. In the present study this model will be tested using four modified administration schemes. The goal of this study is to experimentally test different intravenous DMT administration schedules to investigate the subjective and autonomic effects of DMT in healthy subjects. The study is expected to inform researchers on dosing regimes of intravenous DMT as a tool to examine alterations of the mind and is of interest for psychology and psychiatry. This study does not intend to provide any therapeutic benefit for the participants. Currently, no study has validly determined the elimination half-life of DMT and other pharmacokinetic parameters. The key aim is to test the dose-response of DMT as well as the difference between the loading dose bolus and no-bolus perfusion conditions regarding pharmacokinetic, subjective, and autonomic effects including psychological and physical tolerability.
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, 5-period cross-over design with 4 different doses of DMT and placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Dimethyltryptamine (DMT)
    Intravenous DMT bolus and/or DMT maintenance perfusion over 90 min
  • Drug: Saline
    Intravenous saline bolus and/or saline maintenance perfusion over 90 min
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Bolus of 0 mg DMT + perfusion of 0 mg/min DMT over 60 min, resulting in a total dose of 0 mg DMT.
    Intervention: Drug: Saline
  • Experimental: Low dose
    Intravenous bolus of 0 mg DMT + perfusion of 0.6 mg/min DMT over 90 min, resulting in a total dose of 54 mg DMT.
    Interventions:
    • Drug: Dimethyltryptamine (DMT)
    • Drug: Saline
  • Experimental: Low dose with bolus
    Intravenous bolus of 15 mg DMT + perfusion of 0.6 mg/min DMT over 90 min, resulting in a total dose of 69 mg DMT.
    Intervention: Drug: Dimethyltryptamine (DMT)
  • Experimental: High dose
    Intravenous bolus of 0 mg DMT + perfusion of 1 mg/min DMT over 90 min, resulting in a total dose of 90 mg DMT.
    Interventions:
    • Drug: Dimethyltryptamine (DMT)
    • Drug: Saline
  • Experimental: High dose with bolus
    Intravenous bolus of 25 mg DMT + perfusion of 1 mg/min DMT over 90 min, resulting in a total dose of 115 mg DMT.
    Intervention: Drug: Dimethyltryptamine (DMT)
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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 15, 2020)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 1, 2022
Estimated Primary Completion Date July 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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 from the evenings prior to the study sessions and during the sessions
  • Willing not to operate heavy machinery within 6 h of DMT administration
  • Willing to use double-barrier birth control throughout study participation
  • Body mass index between 18-29 kg/m2

Exclusion Criteria:

  • Chronic or acute medical condition
  • Current or previous major psychiatric disorder
  • Psychotic disorder or bipolar disorder in first-degree relatives
  • Hypertension (SBP>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)
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, Prof. Dr. MD 061 328 68 68 ext +41 matthias.liechti@usb.ch
Contact: Laura Ley, MSc 061 328 77 42 ext +41 laura.ley@usb.ch
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04353024
Other Study ID Numbers  ICMJE BASEC 2020-00376
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, Prof. Dr. MD University Hospital, Basel, Switzerland
PRS Account University Hospital, Basel, Switzerland
Verification Date February 2021

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