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Neurodynamics of Prosocial Emotional Processing Following Serotonergic Stimulation With N,N-Dimethyltryptamine (DMT) and Harmine in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT04716335
Recruitment Status : Recruiting
First Posted : January 20, 2021
Last Update Posted : January 20, 2021
Sponsor:
Collaborator:
University of Basel
Information provided by (Responsible Party):
Milan Scheidegger, Psychiatric University Hospital, Zurich

Tracking Information
First Submitted Date  ICMJE December 23, 2020
First Posted Date  ICMJE January 20, 2021
Last Update Posted Date January 20, 2021
Actual Study Start Date  ICMJE December 1, 2020
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 15, 2021)
  • Change in Behavioral Outcome Measures (Social Value Orientation - SVO, Charity Donation Frank Task) [ Time Frame: Acute drug effects (240 minutes - Charity Donation Frank Task, 300 minutes - SVO) ]
    Social Cognition
  • Change in Behavioral Outcome Measures (Visuall Oddball, Karaoke Task) [ Time Frame: Acute drug effects (60 min - Visuall Oddball, 150 min - Karaoke Task) ]
    Self-referential Processing
  • Change in Pharmacological-EEG (Lagged Phase Synchronicity) [ Time Frame: Baseline, Acute drug effects (30 minutes , 135 minutes, 195 minutes, 285 minutes) ]
    Functional brain connectivity
  • Change in Pharmacological-EEG (Resting State) [ Time Frame: Baseline, Acute drug effects (30 minutes , 135 minutes, 195 minutes, 285 minutes) ]
    Spectral Density
  • Change in Pharmacological-EEG [ Time Frame: Acute drug effects (60 minutes, 240 minutes) ]
    Event-Related Potentials (ERP)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 15, 2021)
  • Change in biomarkers [ Time Frame: Baseline, Acute drug effects (0 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, 210 minutes, 240 minutes, 270 minutes, 300 minutes) ]
    Tryptophan catabolites (TRYCAT)
  • Change in biomarkers [ Time Frame: Baseline, Acute drug effects (30 minutes, 90 minutes, 150 minutes, 300 minutes) ]
    Brain-derived Neurotrophic Factor (BDNF)
  • Change in biomarkers [ Time Frame: Baseline, Acute drug effects (0 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, 210 minutes, 240 minutes, 270 minutes, 300 minutes) ]
    Hypothalamic-Pituitary-Adrenal Axis (HPA-A)
  • Change in biomarkers [ Time Frame: Baseline, Acute drug effects (0 minutes, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes, 210 minutes, 240 minutes, 270 minutes, 300 minutes) ]
    API (DMT, Harmine)
  • Change in biomarkers [ Time Frame: Baseline, Acute drug effects (30 minutes, 90 minutes, 150 minutes, 300 minutes) ]
    Neuroinflammation - Interleukines
  • Change in biomarkers [ Time Frame: Baseline, Acute drug effects (30 minutes, 90 minutes, 150 minutes, 300 minutes) ]
    Oxidative Stress Markers (Nitric Oxide Synthase)
  • Psychometry [ Time Frame: Baseline, Acute, 1 day after, 1 week after, 1 month after and 4 month after intervention ]
    Cognitive Flexibility
  • Psychometry [ Time Frame: Baseline, Acute, 1 day after, 1 week after, 1 month after and 4 month after intervention ]
    MINDSENS
  • Psychometry [ Time Frame: Baseline, Acute, 1 day after, 1 week after, 1 month after and 4 month after intervention ]
    PANAS
  • Psychometry [ Time Frame: Baseline, Acute, 1 day after, 1 week after, 1 month after and 4 month after intervention ]
    CFI
  • Psychometry [ Time Frame: Baseline, Acute, 1 day after, 1 week after, 1 month after and 4 month after intervention ]
    SRQ
  • Psychometry [ Time Frame: Baseline, Acute, 1 day after, 1 week after, 1 month after and 4 month after intervention ]
    MBQ
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neurodynamics of Prosocial Emotional Processing Following Serotonergic Stimulation With N,N-Dimethyltryptamine (DMT) and Harmine in Healthy Subjects
Official Title  ICMJE Neurodynamics of Prosocial Emotional Processing Following Serotonergic Stimulation With N,N-Dimethyltryptamine (DMT) and Harmine in Healthy Subjects
Brief Summary The aim of the project is to assess brain network dynamics, self-referential information processing and prosociality and learning following the modulation of the serotonin-system by serotonergic-psychoactive compounds.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE
  • Emotions
  • Mood
  • Cognitive Function 1, Social
  • Empathy
Intervention  ICMJE
  • Drug: DMT
    DMT (max. 100mg; intranasal over 120 minutes)
  • Drug: Harmine
    Harmine (100mg; sublingual)
  • Drug: Placebo (Harmine)
    Placebo for Harmine (sublingual)
  • Drug: Placebo (DMT)
    Placebo for DMT (intranasal)
Study Arms  ICMJE
  • Experimental: Harmine + DMT
    Interventions:
    • Drug: DMT
    • Drug: Harmine
  • Experimental: Harmine + Placebo(DMT)
    Interventions:
    • Drug: Harmine
    • Drug: Placebo (DMT)
  • Placebo Comparator: Placebo(Harmin & Placebo)
    Interventions:
    • Drug: Placebo (Harmine)
    • Drug: Placebo (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 15, 2021)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2021
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Willing and capable to give informed consent for the participation in the study after it has been thoroughly explained
  • Little or no previous experiences with psychedelic substances
  • Body mass index (BMI) between 18.5 and 25
  • Willing to refrain from drinking caffeine 3 days and alcohol the day before testing session, from drinking alcohol and caffeinated drinks at the testing days and from consuming psychoactive substances or other medications for 2 weeks before testing days and for the duration of the study
  • Able and willing to comply with all study requirements
  • Informed consent form was signed
  • Good knowledge of the German language

Exclusion Criteria:

  • Previous significant adverse response to a hallucinogenic drug
  • Participation in another study where pharmaceutical compounds will be given
  • Self or first-degree relatives with present or antecedent psychiatric disorders
  • History of head trauma or fainting
  • Recent cardiac or brain surgery
  • Current use of medication or psychotropic substances (including nicotine addiction)
  • Presence of major internal or neurological disorders (including sepsis, pheochromocytoma, thyrotoxicosis, drug-induced fibrosis, familiar or basilar artery migraine)
  • Cardiovascular disease (hypertonia, coronary artery disease, heart insufficiency, myocardial infarction, coronary spastic angina)
  • Peripheral vascular disease (thromboangiitis obliterans, luetic arteritis, severe arteriosclerosis, thrombophlebitis, Raynaud's disease)
  • Liver or renal disease
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Milan Scheidegger, MD, PhD, MA HPK +41 (0)443842325 milan.scheidegger@bli.uzh.ch
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04716335
Other Study ID Numbers  ICMJE 2018-01385
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Milan Scheidegger, Psychiatric University Hospital, Zurich
Study Sponsor  ICMJE Psychiatric University Hospital, Zurich
Collaborators  ICMJE University of Basel
Investigators  ICMJE Not Provided
PRS Account Psychiatric University Hospital, Zurich
Verification Date January 2021

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