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临床试验/NCT07693257
NCT07693257尚未招募1 期

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

Jon Dean1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年9月1日最近更新:
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试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
20
试验地点
1
主要终点
fMRI - Blood Oxygen Level Dependent (BOLD) Signaling
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 65 Years（Adult, Older Adult）
性别
All
接受健康志愿者
是

入选标准

  • •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)

排除标准

  • •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

结局指标

主要结局

fMRI - Blood Oxygen Level Dependent (BOLD) Signaling

时间窗: 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.

次要结局

  • Numeric Rating Sale for current anxiety and pain, and feelings of compassion toward oneself and other(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(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(Up to 3 months: Assessed at baseline fMRI (Visit 2), and dosing fMRI (Visits 6, 8))
  • Hallucinogen Rating Scale(Up to 3 months: Assessed at baseline fMRI (Visit 2), and dosing fMRI (Visits 6, 8))
  • Autonomous Entity Questionnaire(Up to 3 months: Assessed at baseline fMRI (Visit 2), and dosing fMRI (Visits 6, 8))
  • State Anxiety Inventory(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(Up to 3 months: Assessed at dosing fMRI (Visits 6, 8))
  • 11-Dimensional Altered States of Consciousness Questionnaire(Up to 3 months: Assessed at baseline fMRI (Visit 2), and dosing fMRI (Visits 6, 8))
  • Challenging Experiences Questionnaire(Up to 3 months: Assessed at baseline fMRI (Visit 2), and dosing fMRI (Visits 6, 8))
  • Heart Rate(Up to 3 months: Assessed at screening (Visit 1), baseline fMRI (Visit 2), preparatory session (Visit 5), dosing fMRI (Visits 6, 8))
  • Persisting Effects Questionnaire(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(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(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(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(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(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(Up to 4 months: Assessed at baseline fMRI (Visit 2), integration (Visit 9), and follow-up (Visit 12))
  • Adverse events(Up to 6 months: Tracked across all study visits)
  • Blood Pressure(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(Assessed at all study visits from enrollment through completion of the 4-week post-dosing follow-up (Visit 12))

研究者

发起方
Jon Dean
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jon Dean

Assistant Professor, Director of DMT Research

University of California, San Diego

研究点 (1)

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