Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DMT 0.6 mg/min | Experimental |
| |
| DMT 1.2 mg/min | Experimental |
| |
| DMT 1.8 mg/min | Experimental |
| |
| DMT 2.4 mg/min | Experimental |
| |
| Placebo | Placebo Comparator |
| |
| DMT 1.2 mg/min + dose titration | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N,N-Dimethyltryptamine (54 mg) | Drug | A dose rate of 0.6 mg/min will be administered |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Altered states of consciousness profile (5D-ASC) | 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 | 12 months |
| Subjective effect ratings over time | 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| States of consciousness questionnaire (SCQ) | 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 | 12 months |
| Spiritual Realms Questionnaire |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Matthias E Liechti, MD | University Hospital Basel, Basel, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universtity Hospital Basel | Basel | 4056 | Switzerland |
Not provided
| ID | Term |
|---|---|
| D004130 | N,N-Dimethyltryptamine |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D000588 | Amines |
Not provided
Not provided
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).
Not provided
Not provided
Not provided
| N,N-Dimethyltryptamine (108 mg) |
| Drug |
A dose rate of 1.2 mg/min will be administered |
|
| N,N-Dimethyltryptamine (162 mg) | Drug | A dose rate of 1.8 mg/min will be administered |
|
| N,N-Dimethyltryptamine (216 mg) | Drug | A dose rate of 2.4 mg/min will be administered |
|
| Placebo | Drug | A Placebo (saline infusion) will be administered. |
|
| N,N-Dimethyltryptamine (108 mg) + dose titration | Drug | A dose rate of 1.2 mg/min will be administered with subsequent patient-guided dose titration |
|
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 |
| 12 months |
| Blood pressure | Assessed 20 times on each study day via systolic and diastolic blood pressure | 12 months |
| heart rate | Assessed 20 times on each study day via heart rate | 12 months |
| body temperature | Assessed 20 times on each study day via tympanic body temperature | 12 months |
| Plasma level DMT | Assessed 22 times on each study day | 12 months |
| Plasma level of oxytocin | Assessed 3 times on each study day | 12 months |
| Plasma level of cortisol | Assessed 3 times on each study day | 12 months |
| Plasma level of BDNF | Assessed 3 times on each study day | 12 months |
| Plasma level of Prolactin | Assessed 3 times on each study day | 12 months |
| Urine recovery of DMT | Assessed once on each study day | 12 months |
| NEO-Five-Factor-Inventory (NEO-FFI) | 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". | Baseline |
| Saarbrücker Personality Questionnaire (SPF) | 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. | Baseline |
| Elliot Humility Scale (EHS) | 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" | Baseline |
| D009930 |
| Organic Chemicals |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |