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Acute Dose-dependent Effects of DMT in Healthy Subjects: A Placebo-controlled Cross-over Study (DMT DR)

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ClinicalTrials.gov Identifier: NCT05384678
Recruitment Status : Not yet recruiting
First Posted : May 20, 2022
Last Update Posted : May 20, 2022
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Tracking Information
First Submitted Date  ICMJE May 17, 2022
First Posted Date  ICMJE May 20, 2022
Last Update Posted Date May 20, 2022
Estimated Study Start Date  ICMJE September 1, 2022
Estimated Primary Completion Date August 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 17, 2022)
  • Altered states of consciousness profile (5D-ASC) [ Time Frame: 12 months ]
    5 Dimensions of Altered States of Consciousness (5D-ASC) consisting of 94 items to be rated on a visual analog scale (0-100 mm), with higher values indicating stronger effects with higher scores representing more intense effects. Assessed once on each study day
  • Subjective effect ratings over time [ Time Frame: 12 months ]
    Participants will be asked by the investigator to repeatedly rate their subjective effects verbally on a Likert scale from 0 to 10 for: "any drug effect", "good drug effect", "bad drug effect", and "fear". Ratings will be performed before and repeatedly after substance administration and will take approximately 30 sec complete.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2022)
  • AMRS [ Time Frame: 12 months ]
    Assessed twice at each study session via adjective mood rating scale (AMRS)
  • MEQ43 [ Time Frame: 12 months ]
    Assesses 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") once on each study day
  • Spiritual Realms Questionnaire [ Time Frame: 12 months ]
    Assesses the spiritual phenomenons elicited by psychedelic substances through 11 main questions to be answered on a total of 65 sub-ordered 100mm visual analog scales once on each study day
  • Blood pressure [ Time Frame: 12 months ]
    Assessed 20 times on each study day via systolic and diastolic blood pressure
  • heart rate [ Time Frame: 12 months ]
    Assessed 20 times on each study day via heart rate
  • body temperature [ Time Frame: 12 months ]
    Assessed 20 times on each study day via tympanic body temperature
  • Plasma level DMT [ Time Frame: 12 months ]
    Assessed 22 times on each study day
  • Plasma level of oxytocin [ Time Frame: 12 months ]
    Assessed 3 times on each study day
  • Plasma level of cortisol [ Time Frame: 12 months ]
    Assessed 3 times on each study day
  • Plasma level of BDNF [ Time Frame: 12 months ]
    Assessed 3 times on each study day
  • Plasma level of Prolactin [ Time Frame: 12 months ]
    Assessed 3 times on each study day
  • Urine recovery of DMT [ Time Frame: 12 months ]
    Assessed once on each study day
  • NEO-Five-Factor-Inventory (NEO-FFI) [ Time Frame: Baseline ]
    The NEO-FFI is a self-description questionnaire with 60 items for the measurement of the "big five": neuroticism, extraversion, openness, agreeableness, and consciousness. It uses a 5-point Likert scale ranging from "completely disagree" to "fully agree".
  • Freiburger Personality Inventory (FPI-R) [ Time Frame: Baseline ]
    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 Personality Questionnaire (SPF) [ Time Frame: Baseline ]
    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.
  • Elliot Humility Scale (EHS) [ Time Frame: Baseline ]
    The Elliot Humility Scale (EHS) is a validated 13-item self-rating measure assessing four subscales, i.e. openness, self-forgetfulness, accurate self-assessment, and focus on others on a 5-point Likert scale ranging from "strongly disagree" to "strongly agree"
  • Defense Style Questionnaire (DSQ-40) [ Time Frame: Baseline ]
    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".
  • Jankowski Humility Scale (JHS) [ Time Frame: Baseline ]
    The Jankowski Humility Scale (JHS) is an 18-item self-report measure derived from an unpublished scale (Bollinger, DMT DR Study Protocol 06.04.2022 Version 2 Seite 19 von 42 Kopp, Hill, & Williams, 2006) reflecting four humility subscales, i.e. entitlement, appreciation of limitations, low self-focus and having an accurate assessment of oneself.
  • Psychological insight (PIQ) [ Time Frame: Baseline ]
    The Psychological Insight Questionnaire (PIQ) is a newly developed instrument to assess the degree to which an event has facilitated acute insight and gained awareness into emotions, behaviors, beliefs, memories, or relationships [Davis, 2020 #6789]. The 14 items resulting from a recent validation process are to be rated on a 6-point Likert scale ranging from 0 = "No; not at all" to 5 = "Extremely (more than ever before in my life).
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 Acute Dose-dependent Effects of DMT in Healthy Subjects: A Placebo-controlled Cross-over Study
Official Title  ICMJE Acute Dose-dependent Effects of DMT in Healthy Subjects: A Placebo-controlled Cross-over Study
Brief Summary N,N-dimethyltryptamine (DMT) is a psychoactive substance with similar effects such as LSD or psilocybin. However, DMT is less well characterized than the latter substances. The present study is a modern randomized cross-over trial, investigating different continuous intravenous DMT dose rates over a broad dose range. Thus, different doses will be tested and related to subjective and autonomic effects.
Detailed Description N,N-dimethyltryptamine (DMT) is a naturally-occurring psychedelic substance widely used in recreational and spiritual settings (Ayahuasca). DMT is considered 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). In Ayahuasca, DMT is consumed together with harmala alkaloids that inhibit MAO to increase the oral bioavailablitity of DMT and to prolong its action after oral use. Alternatively, an intravenous administration regime including a bolus and maintenance perfusion has been proposed to induce a stable and prolonged DMT experience and is currently being investigated. However, to date no clinical study has investigated dose-response effects over a broad range of different doses of DMT within the same patient. The aim of the present study is to experimentally test different intravenous DMT doses over a broad dose range and investigate the related subjective and autonomic effects in order to establish a precise dose-response relationship of DMT in healthy subjects.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
5-period random order, placebo-controlled, double-blind cross-over study with four active substance conditions and placebo: 1. 0.6 mg/min, 2. 1.2 mg/min, 3. 1.8 mg/min, 4. 2.4 mg/min, 5. Placebo. Additionally, a patient-guided titration will be performed at the sixth and last session (not randomized).
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: N,N-Dimethyltryptamine (54 mg)
    A dose rate of 0.6 mg/min will be administered
  • Drug: N,N-Dimethyltryptamine (108 mg)
    A dose rate of 1.2 mg/min will be administered
  • Drug: N,N-Dimethyltryptamine (162 mg)
    A dose rate of 1.8 mg/min will be administered
  • Drug: N,N-Dimethyltryptamine (216 mg)
    A dose rate of 2.4 mg/min will be administered
  • Drug: Placebo
    A Placebo (saline infusion) will be administered.
  • Drug: N,N-Dimethyltryptamine (108 mg) + dose titration
    A dose rate of 1.2 mg/min will be administered with subsequent patient-guided dose titration
Study Arms  ICMJE
  • Experimental: DMT 0.6 mg/min
    Intervention: Drug: N,N-Dimethyltryptamine (54 mg)
  • Experimental: DMT 1.2 mg/min
    Intervention: Drug: N,N-Dimethyltryptamine (108 mg)
  • Experimental: DMT 1.8 mg/min
    Intervention: Drug: N,N-Dimethyltryptamine (162 mg)
  • Experimental: DMT 2.4 mg/min
    Intervention: Drug: N,N-Dimethyltryptamine (216 mg)
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: DMT 1.2 mg/min + dose titration
    Intervention: Drug: N,N-Dimethyltryptamine (108 mg) + dose titration
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: May 17, 2022)
24
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2023
Estimated Primary Completion Date August 31, 2023   (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 from the evenings prior to the study sessions and during the sessions
  7. Willing not to operate heavy machinery within 6 h of DMT 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 (e.g. psychotic disorders, mania / hypomania, anxiety disorders).
  3. Psychotic disorder or bipolar disorder in first-degree relatives
  4. Hypertension (SBP>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, MD 61 328 68 68 ext +41 matthias.liechti@usb.ch
Contact: Severin B Vogt, MD 61 328 68 66 ext +41 severinbenjamin.vogt@usb.ch
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05384678
Other Study ID Numbers  ICMJE BASEC 2022-00378
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
Current Responsible Party University Hospital, Basel, Switzerland
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University Hospital, Basel, Switzerland
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Matthias E Liechti, MD University Hospital Basel, Basel, Switzerland
PRS Account University Hospital, Basel, Switzerland
Verification Date May 2022

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