Scientists map brain changes during Hour-Long DMT experience

NCT ID NCT07693257

Knowledge-focused Sponsor: Jon Dean Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
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Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This study investigates how a continuous intravenous infusion of DMT, a psychedelic substance, alters brain activity and perception over an extended period. Healthy volunteers with prior DMT experience will receive low and medium doses for one hour while undergoing fMRI scans. Researchers aim to identify brain patterns linked to the visual and emotional effects of DMT, providing insights into its neural mechanisms.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
N,N-dimethyltryptamine (DMT)
What this could lead to
If successful, this could reveal how DMT alters brain function during prolonged experiences, potentially informing future therapies for mood disorders.
What could go wrong
This is a small Phase 1 study in healthy volunteers, so results may not apply to broader populations. DMT can cause intense psychological effects, and the study does not test therapeutic benefits.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 * 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) Exclusion Criteria: * 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 * 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

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As listed by the trial registrant

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How to take part

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Contacts and locations

Locations

  • Altman Clinical and Translational Research Institute

    La Jolla, California, 92037, United States

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