Neural Effects of Intravenous N,N-dimethyltryptamine (DMT)

ConditionHealthy Participants Study

Trial statusNot yet recruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-65

SponsorJon Dean

About this trial

This study examines how the psychedelic substance DMT affects the human brain when administered by the intravenous (IV) route. DMT is a naturally occurring chemical in the body that is thought to help improve mood when ingested in a continuously monitored medical setting. Previous research has shown that a single IV injection of DMT can be given safely, but its effects, which include changes in perception, emotions, and thinking, usually wear off within 15-20 minutes.

To better understand what happens when DMT's effects last longer, researchers have developed a method to give DMT slowly and continuously through an IV, which safely extends its effects for up to an hour or more. In this study, healthy volunteers who have prior experience using DMT will receive low and medium doses of DMT in this extended manner through an IV for 1 hour while undergoing a brain scanning technique known as functional magnetic resonance imaging (fMRI). These scans allow researchers to see changes in brain activity and blood flow in real time.

Participants will complete psychological assessments before and after receiving DMT, and additional brain scans without DMT will be used for comparison. The researchers will also use advanced computer techniques to help identify brain patterns linked to the visual experiences people report during DMT.

Overall, the goal of the study is to better understand how DMT affects the brain during an extended experience and to learn more about the biological processes behind its psychological effects.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

18 to 65 years of age

Able to fluently communicate in English

Agree to sign the consent and HIPAA authorization

Not taking serotonergic antidepressant medication

Disqualifiers

Pregnant or nursing females

Females of childbearing potential who are sexually active but not using birth control

MRI contraindications (e.g., pacemakers, metal implants, spinal cord stimulators)

Current DSM-5 diagnosis of depression or anxiety (or within past 6 months), bipolar disorder, schizophrenia, or other psychotic disorder

Trial design

Design model

Crossover

Treatments tested in this trial

N,N-Dimethyltryptamine (15 mg)
Drug
Participants will receive one "low" dose (15 mg for 1 min + 1.5 mg/min for 59 min) of synthetic DMT (hemifumarate) via IV injection.
N,N-Dimethyltryptamine (17.5 mg)
Drug
Participants will receive one "medium" dose (17.5 mg for 1 min + 1.75 mg/min for 59 min) of synthetic DMT (hemifumarate) via IV injection.

Treatment groups

20 Participants

are divided into 2 treatment groups

Group A: DMT hemifumarate "low" doseExperimental treatment 1 intervention

Group B: DMT hemifumarate "medium" doseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

fMRI - Blood Oxygen Level Dependent (BOLD) Signaling

Whole brain BOLD fMRI acquired during the peak subjective effects of IV administration of two separate doses ("low" and "medium") of DMT hemifumarate over a 60 min period for comparison across time, between dose, and versus rest/saline infusion.

Time frame

Up to 3 months: Assessed at baseline fMRI (Visit 2) and dosing fMRI (Visits 6, 8).

Secondary outcomes

Numeric Rating Sale for current anxiety and pain, and feelings of compassion toward oneself and other

Likert scale ranging from 0 to 10, with higher scores indicating higher anxiety, pain, and compassion, respectively

Time frame

Up to 4 months: Assessed at baseline fMRI (Visit 2), dosing fMRI (Visits 6, 8), integration (Visits 7, 9), and follow-up (Visits 10, 11, 12)

Numeric Rating Sale for current mood and stress

Likert scale ranging from 0 to 10, with higher scores endorsing the feeling of being more upset and more stress, respectively

Time frame

Up to 6 months: Assessed at baseline (Visit 2), dosing fMRI (Visits 6, 8), integration (Visits 7, 9), follow-up (Visits 10, 11, 12), and post-dosing fMRI (Visits 13, 14, 15)

Numeric Rating Scale for immersion, visual effects, distortion in time perception, good and bad drug effects, drug intensity, and entity phenomena experienced

Likert scale ranging from 0 to 10, with higher scores indicating higher endorsement of respective constructs

Time frame

Up to 3 months: Assessed at baseline fMRI (Visit 2), and dosing fMRI (Visits 6, 8)

Hallucinogen Rating Scale

Measures the acute subjective effects of hallucinogenic drugs across six domains: intensity, somaesthesia, affect, perception, cognition, and volition. Participants rate 100 items on a 5-point Likert scale (0-4), and domain scores are calculated as the mean of items within each domain, with higher scores indicating greater intensity of psychedelic effects

Time frame

Up to 3 months: Assessed at baseline fMRI (Visit 2), and dosing fMRI (Visits 6, 8)

Other outcomes

Participant validation of BOLD fMRI-based visual decoding models

Machine learning-based diffusion models will be trained using participants' verbal reports of DMT visual phenomena and corresponding visual cortex BOLD fMRI activity obtained during dosing fMRI sessions. Additional post-dosing fMRI sessions, during which participants view Natural Scenes Dataset images and AI-generated images corresponding to their reported DMT visual imagery, will be used to train and optimize the decoding models. Participants will subsequently validate decoder-generated visual outputs by selecting the reconstructed image from sets containing distractor images and by rating how closely each reconstructed image matches the remembered DMT visual experience using a numeric rating scale (0 = no resemblance; 10 = exact resemblance). Higher scores indicate greater agreement between reconstructed and remembered visual imagery.

Time frame

Up to 6 months: Assessed at dosing fMRI (Visits 6, 8) post-dosing fMRI (Visits 13, 14, 15), and validation (Visit 16)

Plasma levels of DMT, indole-3-acetic acid, and DMT-N-Oxide

Assessed 18 times on each study dosing visit via blood sampling

Time frame

110 minutes

Salivary levels of DMT, indole-3-acetic acid, and DMT-N-Oxide

Assessed up to 3 times on each study dosing visit via saliva sampling

Time frame

60 minutes

Plasma levels of cortisol, oxytocin, and BDNF

Assessed up to 18 times on each study dosing visit via blood sampling

Time frame

110 minutes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jon Dean

Lead sponsor

University of California, San Diego

Sponsor institution

Source ClinicalTrials.gov

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