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

Sponsor
University Hospital, Basel, Switzerland (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05384678
Collaborator
(none)
24
Enrollment
6
Arms
12.9
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: N,N-Dimethyltryptamine (54 mg)
  • Drug: N,N-Dimethyltryptamine (108 mg)
  • Drug: N,N-Dimethyltryptamine (162 mg)
  • Drug: N,N-Dimethyltryptamine (216 mg)
  • Drug: Placebo
  • Drug: N,N-Dimethyltryptamine (108 mg) + dose titration
 Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
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).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
Official Title:
Acute Dose-dependent Effects of DMT in Healthy Subjects: A Placebo-controlled Cross-over Study
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Aug 31, 2023
Anticipated Study Completion Date :
Sep 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: DMT 0.6 mg/min

Drug: N,N-Dimethyltryptamine (54 mg)
A dose rate of 0.6 mg/min will be administered
Experimental: DMT 1.2 mg/min

Drug: N,N-Dimethyltryptamine (108 mg)
A dose rate of 1.2 mg/min will be administered
Experimental: DMT 1.8 mg/min

Drug: N,N-Dimethyltryptamine (162 mg)
A dose rate of 1.8 mg/min will be administered
Experimental: DMT 2.4 mg/min

Drug: N,N-Dimethyltryptamine (216 mg)
A dose rate of 2.4 mg/min will be administered
Placebo Comparator: Placebo

Drug: Placebo
A Placebo (saline infusion) will be administered.
Experimental: DMT 1.2 mg/min + dose titration

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

Outcome Measures

Primary Outcome Measures

  1. Altered states of consciousness profile (5D-ASC) [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

  2. Subjective effect ratings over time [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.

Secondary Outcome Measures

  1. AMRS [12 months]

    Assessed twice at each study session via adjective mood rating scale (AMRS)

  2. MEQ43 [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

  3. Spiritual Realms Questionnaire [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

  4. Blood pressure [12 months]

    Assessed 20 times on each study day via systolic and diastolic blood pressure

  5. heart rate [12 months]

    Assessed 20 times on each study day via heart rate

  6. body temperature [12 months]

    Assessed 20 times on each study day via tympanic body temperature

  7. Plasma level DMT [12 months]

    Assessed 22 times on each study day

  8. Plasma level of oxytocin [12 months]

    Assessed 3 times on each study day

  9. Plasma level of cortisol [12 months]

    Assessed 3 times on each study day

  10. Plasma level of BDNF [12 months]

    Assessed 3 times on each study day

  11. Plasma level of Prolactin [12 months]

    Assessed 3 times on each study day

  12. Urine recovery of DMT [12 months]

    Assessed once on each study day

  13. NEO-Five-Factor-Inventory (NEO-FFI) [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".

  14. Freiburger Personality Inventory (FPI-R) [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").

  15. Saarbrücker Personality Questionnaire (SPF) [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.

  16. Elliot Humility Scale (EHS) [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"

  17. Defense Style Questionnaire (DSQ-40) [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".

  18. Jankowski Humility Scale (JHS) [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.

  19. Psychological insight (PIQ) [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Matthias E Liechti, MD, University Hospital Basel, Basel, Switzerland

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT05384678
Other Study ID Numbers:
  • BASEC 2022-00378
First Posted:
May 20, 2022
Last Update Posted:
May 20, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
N,N-Dimethyltryptamine

Study Results

No Results Posted as of May 20, 2022