History of Changes for Study: NCT05384678

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

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Study Record Versions

Version	Submitted Date	Changes
1	May 17, 2022	None (earliest Version on record)
2	October 10, 2022	Recruitment Status, Study Status, Outcome Measures, Contacts/Locations and Study Identification
3	November 1, 2022	Study Status
4	January 30, 2023	Study Status
5	November 20, 2023	Study Status
6	April 24, 2024	Recruitment Status, Study Status, Contacts/Locations and Study Design

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Study Identification


Unique Protocol ID:	BASEC 2022-00378
Brief Title:	Acute Dose-dependent Effects of DMT in Healthy Subjects: A Placebo-controlled Cross-over Study (DMT DR)
Official Title:	Acute Dose-dependent Effects of DMT in Healthy Subjects: A Placebo-controlled Cross-over Study
Secondary IDs:

Study Status


Record Verification:	May 2022
Overall Status:	Not yet recruiting
Study Start:	September 1, 2022
Primary Completion:	August 31, 2023 [Anticipated]
Study Completion:	September 30, 2023 [Anticipated]

First Submitted:	May 17, 2022
First Submitted that Met QC Criteria:	May 17, 2022
First Posted:	May 20, 2022 [Actual]

Last Update Submitted that Met QC Criteria:	May 17, 2022
Last Update Posted:	May 20, 2022 [Actual]

Sponsor/Collaborators


Sponsor:	University Hospital, Basel, Switzerland
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	No
U.S. FDA-regulated Device:	No
Data Monitoring:	Yes

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.

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.

Conditions


Conditions:	Healthy
Keywords:

Study Design


Study Type:	Interventional
Primary Purpose:	Basic Science
Study Phase:	Phase 1
Interventional Study Model:	Crossover Assignment
	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).
Number of Arms:	6
Masking:	Triple (Participant, Care Provider, Investigator)
Allocation:	Randomized
Enrollment:	24 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
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) [ 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
2.	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.
Secondary Outcome Measures:
1.	AMRS [ Time Frame: 12 months ] Assessed twice at each study session via adjective mood rating scale (AMRS)
2.	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
3.	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
4.	Blood pressure [ Time Frame: 12 months ] Assessed 20 times on each study day via systolic and diastolic blood pressure
5.	heart rate [ Time Frame: 12 months ] Assessed 20 times on each study day via heart rate
6.	body temperature [ Time Frame: 12 months ] Assessed 20 times on each study day via tympanic body temperature
7.	Plasma level DMT [ Time Frame: 12 months ] Assessed 22 times on each study day
8.	Plasma level of oxytocin [ Time Frame: 12 months ] Assessed 3 times on each study day
9.	Plasma level of cortisol [ Time Frame: 12 months ] Assessed 3 times on each study day
10.	Plasma level of BDNF [ Time Frame: 12 months ] Assessed 3 times on each study day
11.	Plasma level of Prolactin [ Time Frame: 12 months ] Assessed 3 times on each study day
12.	Urine recovery of DMT [ Time Frame: 12 months ] Assessed once on each study day
13.	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".
14.	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").
15.	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.
16.	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"
17.	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".
18.	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.
19.	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).

Eligibility


Minimum Age:	25 Years
Maximum Age:	65 Years
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	Yes
Criteria:	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 (e.g. psychotic disorders, mania / hypomania, anxiety disorders). 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)

Contacts/Locations


Central Contact Person:	Matthias E Liechti, MD Telephone: 61 328 68 68 Ext. +41 Email: matthias.liechti@usb.ch
Central Contact Backup:	Severin B Vogt, MD Telephone: 61 328 68 66 Ext. +41 Email: severinbenjamin.vogt@usb.ch
Study Officials:	Matthias E Liechti, MD Principal Investigator University Hospital Basel, Basel, Switzerland
Locations:

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