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Fixed Order, Open-Label, Dose-Escalation Study of DMT in Humans

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ClinicalTrials.gov Identifier: NCT04711915
Recruitment Status : Recruiting
First Posted : January 15, 2021
Last Update Posted : March 12, 2021
Sponsor:
Information provided by (Responsible Party):
Deepak C. D'Souza, Yale University

Tracking Information
First Submitted Date  ICMJE January 12, 2021
First Posted Date  ICMJE January 15, 2021
Last Update Posted Date March 12, 2021
Estimated Study Start Date  ICMJE March 15, 2021
Estimated Primary Completion Date December 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2021)
  • Change in Blood Pressure [ Time Frame: -60 and -30 minutes before DMT administration; 0, +5, +10, +15, +20, +30, +45, +60, and +120 minutes after DMT administration ]
    Systolic and diastolic blood pressure will be measured before and several times after the administration of DMT on each test day.
  • Change in Heart Rate [ Time Frame: -60 and -30 minutes before DMT administration; 0, +5, +10, +15, +20, +30, +45, +60, and +120 minutes after DMT administration ]
    Heart rate will be measured before and several times after the administration of DMT on each test day.
  • Change in Psychedelic Effects [ Time Frame: -60 minutes before DMT administration; 0, +30, and +60 minutes after DMT administration ]
    The modified Altered States of Consciousness Rating Scale (ASC) will be used to assess drug-induced altered states of consciousness before and several times after drug administration. This is a 23-item subjective rating scale that will be completed using a visual analog scale format. Questions are scored 0 to 100 each; higher numbers indicate greater psychedelic effects.
  • Change in Anxiety [ Time Frame: -60 minutes before DMT administration; 0, +30, and +60 minutes after DMT administration ]
    Anxiety will be assessed using a visual analog scale that subjects will be asked to score from 0 (not at all) to 100 (worst ever) to capture the net anxiety produced by DMT. This will be collected before and several times after DMT administration.
  • Drug Reinforcing Effects [ Time Frame: +120 minutes after DMT administration ]
    Subjects will be asked to answer questions such as (1) How likely are you to use this drug? and (2) How much are you willing to pay for this experience? using a visual analog scale.
  • Overall Tolerability assessed by the VAS [ Time Frame: +120 minutes after DMT administration ]
    Overall tolerability will be assessed using a visual analog scale that subjects will be asked to score from 0 (well tolerated) to 100 (intolerable) to capture the net tolerability of DMT.
Original Primary Outcome Measures  ICMJE
 (submitted: January 12, 2021)
  • Change in Blood Pressure [ Time Frame: -60 and -30 minutes before DMT administration; 0, +5, +10, +15, +20, +30, +45, +60, and +120 minutes after DMT administration ]
    Blood pressure will be measured before and several times after the administration of DMT on each test day.
  • Change in Heart Rate [ Time Frame: -60 and -30 minutes before DMT administration; 0, +5, +10, +15, +20, +30, +45, +60, and +120 minutes after DMT administration ]
    Heart rate will be measured before and several times after the administration of DMT on each test day.
  • Change in Psychedelic Effects [ Time Frame: -60 minutes before DMT administration; 0, +30, and +60 minutes after DMT administration ]
    The modified Altered States of Consciousness Rating Scale (ASC) will be used to assess drug-induced altered states of consciousness before and several times after drug administration. This is a 23-item subjective rating scale that will be completed using a visual analog scale format. Questions are scored 0 to 100 each; higher numbers indicate greater psychedelic effects.
  • Change in Anxiety [ Time Frame: -60 minutes before DMT administration; 0, +30, and +60 minutes after DMT administration ]
    Anxiety will be assessed using a visual analog scale that subjects will be asked to score from 0 (not at all) to 100 (worst ever) to capture the net anxiety produced by DMT. This will be collected before and several times after DMT administration.
  • Drug Reinforcing Effects [ Time Frame: +120 minutes after DMT administration ]
    Subjects will be asked to answer questions such as (1) How likely are you to use this drug? and (2) How much are you willing to pay for this experience? using a visual analog scale.
  • Overall Tolerability [ Time Frame: +120 minutes after DMT administration ]
    Overall tolerability will be assessed using a visual analog scale that subjects will be asked to score from 0 (well tolerated) to 100 (intolerable) to capture the net tolerability of DMT.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fixed Order, Open-Label, Dose-Escalation Study of DMT in Humans
Official Title  ICMJE Fixed Order, Open-Label, Dose-Escalation Study of DMT in Humans
Brief Summary The goal of this fixed order, open-label, dose-escalation study is to investigate the safety and efficacy of specific doses of dimethyltryptamine (DMT) in humans.
Detailed Description The results of this study will inform the doses to be used in a larger, double-blind, randomized, placebo-controlled, crossover study. Since the goal of the open label study is to inform the double-blind, randomized, placebo-controlled study, the investigators are citing the hypothesis of the latter solely for providing context. The investigators hypothesize that the administration of DMT will result in neuroplastic changes in healthy and depressed subjects. These changes in neuroplasticity will be indexed using electroencephalographic (EEG) measures and tasks. These neuronal changes may in parallel cause changes in mood measured both in healthy and depressed subjects, which will be captured using appropriate psychometric measures of mood.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Healthy individuals and patients with major depressive disorder will participate in this study. Subjects will receive 0.1 mg/kg and 0.3 mg/kg DMT in a fixed order across 2 test days.
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Major Depressive Disorder
  • Depression
Intervention  ICMJE
  • Drug: 0.1 mg/kg Dimethyltryptamine (DMT)
    0.1 mg/kg DMT
    Other Name: Low Dose DMT
  • Drug: 0.3 mg/kg Dimethyltryptamine (DMT)
    0.3 mg/kg DMT
    Other Name: Moderate Dose DMT
Study Arms  ICMJE
  • Active Comparator: 0.1 mg/kg DMT
    0.1 mg/kg DMT administered intravenously
    Intervention: Drug: 0.1 mg/kg Dimethyltryptamine (DMT)
  • Active Comparator: 0.3 mg/kg DMT
    0.3 mg/kg DMT administered intravenously
    Intervention: Drug: 0.3 mg/kg Dimethyltryptamine (DMT)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 12, 2021)
6
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2022
Estimated Primary Completion Date December 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Healthy controls inclusion criteria:

  • Medically healthy
  • Psychiatrically healthy

Healthy controls exclusion criteria:

  • Unstable medical conditions
  • Psychiatric illness

Depression inclusion criteria:

  • Medically healthy
  • Diagnosis of major depressive disorder

Depression exclusion criteria:

-Unstable medical conditions

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Leigh T Flynn, BS 203-932-5711 ext 2557 leigh.flynn@yale.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04711915
Other Study ID Numbers  ICMJE 2000027720
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Deepak C. D'Souza, Yale University
Study Sponsor  ICMJE Yale University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Yale University
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP