HealthyPhase 1DMTNCT04353024
Effects of Dimethyltryptamine in Healthy Subjects
A Phase 1 study testing Dimethyltryptamine (DMT) and Saline in people with Healthy, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Dimethyltryptamine (DMT) and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteSwitzerland
- Study dates
- 18 Jun 2021to 22 Sep 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Dimethyltryptamine (DMT) in Healthy Subjects: A Placebo-controlled Cross-over Study
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Dimethyltryptamine (DMT), Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dimethyltryptamine (DMT)Drug
Intravenous DMT bolus and/or DMT maintenance perfusion over 90 min
SalineDrug
Intravenous saline bolus and/or saline maintenance perfusion over 90 min
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Bolus of 0 mg DMT + perfusion of 0 mg/min DMT over 60 min, resulting in a total dose of 0 mg DMT. Receives: Drug: Saline |
| Low dose | Experimental | 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. Receives: Drug: Dimethyltryptamine (DMT); Drug: Saline |
| Low dose with bolus | Experimental | 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. Receives: Drug: Dimethyltryptamine (DMT) |
| High dose | Experimental | Intravenous bolus of 0 mg DMT + perfusion of 1 mg/min DMT over 90 min, resulting in a total dose of 90 mg DMT. Receives: Drug: Dimethyltryptamine (DMT); Drug: Saline |
| High dose with bolus | Experimental | Intravenous bolus of 25 mg DMT + perfusion of 1 mg/min DMT over 90 min, resulting in a total dose of 115 mg DMT. Receives: Drug: Dimethyltryptamine (DMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Altered states of consciousness profile
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
Measured: 150 minutes
Subjective effect ratings over time
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
Measured: 150 minutes
Secondary outcomes (16)
Subjective mood ratings
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
Measured: 150 minutes
Mystical-type experiences
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")
Measured: 150 minutes
Autonomic effects I
Assessed 22 times on each study day via systolic and diastolic blood pressure, Emax
Measured: 150 minutes
Autonomic effects II
Assessed 22 times on each study day via heart rate, Emax
Measured: 150 minutes
Plasma levels of DMT
Assessed 21 times on each study day via blood samples
Measured: 150 minutes
Plasma levels of blood-derived neurotrophic factor (BDNF)
Assessed 21 times on each study day via blood samples
Measured: 150 minutes
Plasma levels of oxytocin
Assessed twice on each study day via blood samples
Measured: 60 minutes
Renal clearance of DMT
Collected once per study day via one-time interval urine recovery
Measured: 3 hours
Effect moderation through personality traits I
Assessed via NEO-Five-Factor-Inventory (NEO-FFI)
Measured: Baseline
Effect moderation through personality traits II
Assessed via Freiburger Personality Inventory (FPI)
Measured: Baseline
Effect moderation through personality traits III
Assessed via Saarbrücker Personality Questionnaire (SPF)
Measured: Baseline
Effect moderation through personality trait IV
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"
Measured: Baseline
Effect moderation through personality trait V
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"
Measured: Baseline
Effect moderation through personality trait VI
Assessed via Arnett Inventory of Sensation Seeking (AISS-d)
Measured: Baseline
Effect moderation through personality trait VII
Assessed via Defense Style Questionnaire (DSQ-40)
Measured: Baseline
Adverse effects
Assessed via the List of Complaints (LC) which covers the emergence of 66 complaints in a yes/no format
Measured: 150 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start18 Jun 2021
- Primary completion29 Aug 2022
- Study completion22 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double-blind, placebo-controlled, 5-period cross-over design with 4 different doses of DMT and placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthias E Liechti, Prof. Dr. MD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04353024
- Sponsor's protocol ID
- BASEC 2020-00376
- Acronym
- DMT
- Status last verified
- Oct 2022
- First submitted
- 6 Apr 2020
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vogt SB, Ley L, Erne L, Straumann I, Becker AM, Klaiber A, Holze F, Vandersmissen A, Mueller L, Duthaler U, Rudin D, Luethi D, Varghese N, Eckert A, Liechti ME. Acute effects of intravenous DMT in a randomized placebo-controlled study in healthy participants. Transl Psychiatry. 2023 May 23;13(1):172. doi: 10.1038/s41398-023-02477-4.
PubMed 37221177
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dimethyltryptamine (DMT) in Healthy Subjects: A Placebo-controlled Cross-over Study
- ClinicalTrials.gov ID
- NCT04353024
- Acronym / sponsor ID
- DMT / BASEC 2020-00376
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 18 Jun 2021 (actual)
- Primary completion
- 29 Aug 2022 (actual)
- Study completion
- 22 Sep 2022 (actual)
- First posted
- 20 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- Double-blind, placebo-controlled, 5-period cross-over design with 4 different doses of DMT and placebo
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: SalineBolus of 0 mg DMT + perfusion of 0 mg/min DMT over 60 min, resulting in a total dose of 0 mg DMT. |
| Low dose | Experimental | Drug: Dimethyltryptamine (DMT), Drug: SalineIntravenous bolus of 0 mg DMT + perfusion of 0.6 mg/min DMT over 90 min, resulting in a total dose of 54 mg DMT. |
| Low dose with bolus | Experimental | Drug: Dimethyltryptamine (DMT)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. |
| High dose | Experimental | Drug: Dimethyltryptamine (DMT), Drug: SalineIntravenous bolus of 0 mg DMT + perfusion of 1 mg/min DMT over 90 min, resulting in a total dose of 90 mg DMT. |
| High dose with bolus | Experimental | Drug: Dimethyltryptamine (DMT)Intravenous bolus of 25 mg DMT + perfusion of 1 mg/min DMT over 90 min, resulting in a total dose of 115 mg DMT. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dimethyltryptamine (DMT)Intravenous DMT bolus and/or DMT maintenance perfusion over 90 min | Drug | High dose, High dose with bolus, Low dose, Low dose with bolus |
| SalineIntravenous saline bolus and/or saline maintenance perfusion over 90 min | Drug | High dose, Low dose, Placebo |
Primary outcome
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
16 secondary outcomes
Subjective mood ratings
Time frame: 150 minutes
Mystical-type experiences
Time frame: 150 minutes
Autonomic effects I
Time frame: 150 minutes
Autonomic effects II
Time frame: 150 minutes
Plasma levels of DMT
Time frame: 150 minutes
Plasma levels of blood-derived neurotrophic factor (BDNF)
Time frame: 150 minutes
Plasma levels of oxytocin
Time frame: 60 minutes
Renal clearance of DMT
Time frame: 3 hours
Effect moderation through personality traits I
Time frame: Baseline
Effect moderation through personality traits II
Time frame: Baseline
Effect moderation through personality traits III
Time frame: Baseline
Effect moderation through personality trait IV
Time frame: Baseline
Effect moderation through personality trait V
Time frame: Baseline
Effect moderation through personality trait VI
Time frame: Baseline
Effect moderation through personality trait VII
Time frame: Baseline
Adverse effects
Time frame: 150 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2022.
- Derived from this study: PubMed 37221177Vogt SB, Ley L, Erne L, Straumann I, Becker AM, Klaiber A, Holze F, Vandersmissen A, Mueller L, Duthaler U, Rudin D, Luethi D, Varghese N, Eckert A, Liechti ME. Acute effects of intravenous DMT in a randomized placebo-controlled study in healthy participants. Transl Psychiatry. 2023 May 23;13(1):172. doi: 10.1038/s41398-023-02477-4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias E Liechti, Prof. Dr. MD principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dimethyltryptamine (DMT) and Saline in people with Healthy, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Altered states of consciousness profile (time frame: 150 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04353024, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2022.