Healthy Participants StudyPhase 1NCT07693257
Neural Effects of Intravenous N,N-dimethyltryptamine (DMT)
A Phase 1 study testing N,N-Dimethyltryptamine (15 mg) and N,N-Dimethyltryptamine (17.5 mg) in people with Healthy Participants Study, run by Jon Dean at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants Study
- What is being tested?
- N,N-Dimethyltryptamine (15 mg) and N,N-Dimethyltryptamine (17.5 mg)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 1 Sep 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- Willing to refrain from using any non-prescribed psychoactive drugs, including alcohol, within 24 hours before and after study drug administration
- Willing to refrain from consumption of illicit psychoactive substances during the study
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- Agree not to use any nonprescription medications, herbal medications, or supplements during the week prior to each drug session unless an exception is approved by the study investigators
- Willing to refrain from smoking or use of nicotine from 8:00 AM on the morning of drug sessions until discharge at the end of the session
- Have used classic serotonergic hallucinogens (e.g., LSD, psilocybin mushrooms, ayahuasca) without untoward/adverse effects and report "liking" psychedelic drugs with no previous adverse reactions to DMT or other psychedelics
- Report at least 20 lifetime uses of psychedelics, including at least 5 uses of DMT (any form), at least one via inhalation, at least once within the past 2 years, and not within the past 3 months
- Able to remain in an fMRI scanner without sedation and pass fMRI safety screening
- Refrain from caffeine use prior to fMRI scanning
- Women of childbearing potential must agree to use effective birth control from screening through the final visit
- Have a relative or friend available to provide transportation after the drug session
- Not taking medications acting as serotonin antagonists (e.g., cyclobenzaprine, ondansetron), dopamine antagonists (e.g., metoclopramide, promethazine, prochlorperazine), dopamine agonists (e.g., levodopa, pramipexole, apomorphine), psychostimulants (e.g., modafinil, armodafinil, solriamfetol, methylphenidate, dexmethylphenidate, atomoxetine, dextroamphetamine, mixed amphetamine salts, lisdexamfetamine), anticholinergics (e.g., benztropine, trihexyphenidyl, scopolamine, hyoscyamine), or NMDA receptor antagonists (e.g., amantadine, memantine, ketamine)
Who cannot join
- 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
- First-degree relative with bipolar disorder, schizophrenia, or other psychotic disorder
- Suicide risk as determined by clinician assessment and/or C-SSRS
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- Active substance use disorder (excluding tobacco and caffeine)
- Use of serotonergic dietary supplements (e.g., 5-hydroxytryptophan, St. John's wort, SAM-e) if unwilling to discontinue for study duration
- Neurological conditions affecting cognition or perception (e.g., dementia, traumatic brain injury, mild cognitive impairment)
- Positive urine drug screen for amphetamines, barbiturates, buprenorphine, cocaine, methamphetamine, MDMA, methadone, opiates, or phencyclidine
- Use of DMT or another serotonergic hallucinogen within the past 3 months
- Concomitant treatment with antipsychotic medications
- Concomitant treatment with antidepressants, MAO inhibitors, or serotonin reuptake inhibitors (trazodone ≤50 mg/day for insomnia allowed but not within 48 hours of DMT session)
- Severe hearing or visual impairment
- History of seizure disorder or epilepsy
- History of adverse reactions to rescue medications used in the study (benzodiazepines, antipsychotics, labetalol, nitroglycerin, ondansetron)
- Cardiovascular disease or hypertension (SBP >140 mmHg or DBP >90 mmHg)
- Resting heart rate >90 bpm
- Hypotension (SBP <90 mmHg or DBP <60 mmHg)
- QTc prolongation (>0.045 sec for men, >0.047 sec for women)
- History of stroke, angina, clinically significant ECG abnormality, or artificial heart valve
- Severe renal impairment (GFR <30 mL/min/1.73 m²)
- Clinically significant laboratory abnormalities
- History of syncope
- History of vertigo
- Myocardial infarction within 12 months
- Child-Pugh class B or higher, or with alanine aminotransferase or aspartate aminotransferase >2x upper limit of normal
- Concomitant medications associated with serotonin syndrome (e.g., carbamazepine, dextromethorphan, lithium, linezolid, buspirone)
- Severely compromised hepatic function
- Trypanophobia (fear of needles/blood)
- Treatment with another investigational drug within 30 days of screening
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Altman Clinical and Translational Research Institute
La Jolla, California, 92037
Jon Dean, PhD
About this study
Official title: Neural Effects of Continuous Intravenous Infusion of N,N-dimethyltryptamine (DMT)
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.
Read more
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.
- Conditions
- Healthy Participants Study
- Being tested
- N,N-Dimethyltryptamine (15 mg), N,N-Dimethyltryptamine (17.5 mg)
- Keywords
- Intravenous DMT, DMT, Healthy, fMRI, Psychedelics, N,N-dimethyltryptamine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| DMT hemifumarate "low" dose | Experimental | Participants will be randomized to receive, in a double-blinded, counter-balanced, and crossover design, two doses of IV DMT during fMRI scanning delivered within two weeks apart under the care of a study physician. Receives: Drug: N,N-Dimethyltryptamine (15 mg) |
| DMT hemifumarate "medium" dose | Experimental | Participants will be randomized to receive, in a double-blinded, counter-balanced, and crossover design, two doses of IV DMT during fMRI scanning delivered within two weeks apart under the care of a study physician. Receives: Drug: N,N-Dimethyltryptamine (17.5 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 3 months: Assessed at baseline fMRI (Visit 2) and dosing fMRI (Visits 6, 8).
Secondary outcomes (20)
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
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 3 months: Assessed at baseline fMRI (Visit 2), and dosing fMRI (Visits 6, 8)
Autonomous Entity Questionnaire
Measures the presence and characteristics of perceived autonomous entities encountered during altered states of consciousness. Participants rate items assessing occurrence, emotional valence, perceived agency, and interaction with entities on Likert scales (0-100), with higher scores indicating stronger or more elaborate entity experiences
Measured: Up to 3 months: Assessed at baseline fMRI (Visit 2), and dosing fMRI (Visits 6, 8)
State Anxiety Inventory
Measures current (state) anxiety using 20 self-report items rated on a 4-point Likert scale (1-4). Total scores range from 20 to 80, with higher scores indicating greater state anxiety.
Measured: 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)
End of Day Questionnaire
Measures participants' overall experience following study drug administration, including perceived drug effects, adverse events, mood, and general well-being. Responses are collected using Likert scales (typically 0-10 or 1-5 depending on the item), and individual items are analyzed rather than a composite total score
Measured: Up to 3 months: Assessed at dosing fMRI (Visits 6, 8)
11-Dimensional Altered States of Consciousness Questionnaire
Measures multiple dimensions of altered conscious experience, including unity, insightfulness, bliss, disembodiment, anxiety, and visual alterations. Participants rate 42 items on visual analog scales ranging from 0 to 100, and scores are calculated separately for each of the 11 dimensions, with higher scores indicating greater intensity of each experience
Measured: Up to 3 months: Assessed at baseline fMRI (Visit 2), and dosing fMRI (Visits 6, 8)
Challenging Experiences Questionnaire
Measures psychologically difficult experiences during psychedelic administration across domains including fear, grief, paranoia, insanity, isolation, death, and physical distress. Participants rate 26 items on a 6-point scale (0-5), and domain scores are calculated as mean item scores, with higher scores indicating more intense challenging experiences
Measured: Up to 3 months: Assessed at baseline fMRI (Visit 2), and dosing fMRI (Visits 6, 8)
Persisting Effects Questionnaire
Measures long-term perceived changes attributed to the psychedelic experience, including changes in attitudes, mood, behavior, relationships, spirituality, and well-being. Participants rate positive and negative changes on Likert scales (-3 to +3 or 0-5), with higher positive scores reflecting greater beneficial persisting effects
Measured: 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)
Visual Effects Questionnaire
Measures the intensity and frequency of visual phenomena experienced during altered states, including geometric imagery, color enhancement, motion, patterning, and visual distortions. Participants rate items on visual analog scales ranging from 0 to 100, with higher scores indicating greater visual alterations
Measured: 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)
Vividness of Visual Imagery Questionnaire
Measures the vividness of voluntarily generated mental imagery across everyday visual scenarios. Participants rate 16 items on a 5-point scale (1-5). Total scores range from 16 to 80, with higher scores indicating more vivid visual imagery
Measured: 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)
Pittsburgh Sleep Quality Index
Measures subjective sleep quality across seven components including sleep duration, latency, efficiency, disturbances, medication use, and daytime dysfunction. Component scores (0-3) are summed to produce a global score ranging from 0 to 21, with higher scores indicating poorer sleep quality
Measured: 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)
Quick Inventory of Depressive Symptomatology
Measures the severity of depressive symptoms across nine DSM symptom domains using 16 self-report items rated from 0 to 3. Total scores range from 0 to 27, with higher scores indicating greater depression severity
Measured: Up to 4 months: Assessed at baseline fMRI (Visit 2), dosing fMRI (Visits 6, 8), and follow-up (Visits 10, 11, 12)
Five Facet Mindfulness Questionnaire
Measures trait mindfulness across five domains: observing, describing, acting with awareness, nonjudging of inner experience, and nonreactivity to inner experience. Uses a 5-point Likert scale (1-5). Total scores range from 39 to 195, with higher scores indicating greater mindfulness
Measured: 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)
Montreal Cognitive Assessment
Measures global cognitive function across domains including attention, executive function, memory, language, visuospatial ability, abstraction, and orientation. Total scores range from 0 to 30, with higher scores indicating better cognitive performance
Measured: Up to 4 months: Assessed at baseline fMRI (Visit 2), integration (Visit 9), and follow-up (Visit 12)
Adverse events
Tracking all adverse and serious adverse events throughout study participant
Measured: Up to 6 months: Tracked across all study visits
Blood Pressure
Tracking blood pressure readings for >140/90 mmHg and <90/60 mmHg cutoffs
Measured: Up to 3 months: Assessed at screening (Visit 1), baseline fMRI (Visit 2), preparatory session (Visit 5), dosing fMRI (Visits 6, 8)
Heart Rate
Tracking heart rate for >90 bmp exclusion at screening and 110 bpm and (220 - age) * 0.85 bpm during dosing
Measured: Up to 3 months: Assessed at screening (Visit 1), baseline fMRI (Visit 2), preparatory session (Visit 5), dosing fMRI (Visits 6, 8)
Columbia Suicide Severity Rating Scale
Measures the severity of suicidal ideation and suicidal behavior through structured clinician-administered questions assessing the presence, intensity, frequency, duration, controllability, deterrents, and reasons for suicidal thoughts, as well as suicidal behaviors. Suicidal ideation severity is categorized on a 5-point scale (1-5) ranging from a wish to be dead (1) to active suicidal ideation with specific plan and intent (5), while suicidal behaviors are recorded as present or absent
Measured: Assessed at all study visits from enrollment through completion of the 4-week post-dosing follow-up (Visit 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Participants StudyStudies of the same condition, open and under way.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jon Dean
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jon Dean, University of California, San Diego
- Investigators
- Jon Dean, PhD, Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07693257
- Sponsor's protocol ID
- 812478
- Status last verified
- Jul 2026
- First submitted
- 6 Feb 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Effects of Continuous Intravenous Infusion of N,N-dimethyltryptamine (DMT)
- ClinicalTrials.gov ID
- NCT07693257
- Acronym / sponsor ID
- 812478
- Conditions
- Healthy Participants Study
- Keywords
- Intravenous DMT, DMT, Healthy, fMRI, Psychedelics, N,N-dimethyltryptamine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Jon DeanUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 9 Jul 2026 (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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DMT hemifumarate "low" dose | Experimental | Drug: N,N-Dimethyltryptamine (15 mg)Participants will be randomized to receive, in a double-blinded, counter-balanced, and crossover design, two doses of IV DMT during fMRI scanning delivered within two weeks apart under the care of a study physician. |
| DMT hemifumarate "medium" dose | Experimental | Drug: N,N-Dimethyltryptamine (17.5 mg)Participants will be randomized to receive, in a double-blinded, counter-balanced, and crossover design, two doses of IV DMT during fMRI scanning delivered within two weeks apart under the care of a study physician. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
- Willing to refrain from using any non-prescribed psychoactive drugs, including alcohol, within 24 hours before and after study drug administration
Key exclusion criteria (31 listed)
- 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
- First-degree relative with bipolar disorder, schizophrenia, or other psychotic disorder
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 |
|---|---|---|
| N,N-Dimethyltryptamine (15 mg)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. | Drug | DMT hemifumarate "low" dose |
| N,N-Dimethyltryptamine (17.5 mg)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. | Drug | DMT hemifumarate "medium" dose |
Primary outcome
fMRI - Blood Oxygen Level Dependent (BOLD) Signaling
Time frame: Up to 3 months: Assessed at baseline fMRI (Visit 2) and dosing fMRI (Visits 6, 8).
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.
20 secondary outcomes
Numeric Rating Sale for current anxiety and pain, and feelings of compassion toward oneself and other
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
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
Time frame: Up to 3 months: Assessed at baseline fMRI (Visit 2), and dosing fMRI (Visits 6, 8)
Hallucinogen Rating Scale
Time frame: Up to 3 months: Assessed at baseline fMRI (Visit 2), and dosing fMRI (Visits 6, 8)
Autonomous Entity Questionnaire
Time frame: Up to 3 months: Assessed at baseline fMRI (Visit 2), and dosing fMRI (Visits 6, 8)
State Anxiety Inventory
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)
End of Day Questionnaire
Time frame: Up to 3 months: Assessed at dosing fMRI (Visits 6, 8)
11-Dimensional Altered States of Consciousness Questionnaire
Time frame: Up to 3 months: Assessed at baseline fMRI (Visit 2), and dosing fMRI (Visits 6, 8)
Challenging Experiences Questionnaire
Time frame: Up to 3 months: Assessed at baseline fMRI (Visit 2), and dosing fMRI (Visits 6, 8)
Persisting Effects Questionnaire
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)
Visual Effects Questionnaire
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)
Vividness of Visual Imagery Questionnaire
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)
Pittsburgh Sleep Quality Index
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)
Quick Inventory of Depressive Symptomatology
Time frame: Up to 4 months: Assessed at baseline fMRI (Visit 2), dosing fMRI (Visits 6, 8), and follow-up (Visits 10, 11, 12)
Five Facet Mindfulness Questionnaire
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)
Montreal Cognitive Assessment
Time frame: Up to 4 months: Assessed at baseline fMRI (Visit 2), integration (Visit 9), and follow-up (Visit 12)
Adverse events
Time frame: Up to 6 months: Tracked across all study visits
Blood Pressure
Time frame: Up to 3 months: Assessed at screening (Visit 1), baseline fMRI (Visit 2), preparatory session (Visit 5), dosing fMRI (Visits 6, 8)
Heart Rate
Time frame: Up to 3 months: Assessed at screening (Visit 1), baseline fMRI (Visit 2), preparatory session (Visit 5), dosing fMRI (Visits 6, 8)
Columbia Suicide Severity Rating Scale
Time frame: Assessed at all study visits from enrollment through completion of the 4-week post-dosing follow-up (Visit 12)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
Jon Dean, PhD principal investigator
UCSD
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 N,N-Dimethyltryptamine (15 mg) and N,N-Dimethyltryptamine (17.5 mg) in people with Healthy Participants Study, run by Jon Dean at 1 site in United States.
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 15 inclusion and 31 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: opening soon, as of the sponsor's last update on 9 Jul 2026. 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 United States. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yasmeen Esshaki (619-786-0375, deanlaboratory@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fMRI - Blood Oxygen Level Dependent (BOLD) Signaling (time frame: Up to 3 months: Assessed at baseline fMRI (Visit 2) and dosing fMRI (Visits 6, 8).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jul 2026.