Ignite Creation Date:
2025-12-26 @ 10:16 PM
Ignite Modification Date:
2025-12-26 @ 10:16 PM
Study NCT ID:
NCT05901012
Status:
COMPLETED
Last Update Posted:
2023-10-11
First Post:
2023-05-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Tolerability of DMT in Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004130', 'term': 'N,N-Dimethyltryptamine'}], 'ancestors': [{'id': 'D014363', 'term': 'Tryptamines'}, {'id': 'D015306', 'term': 'Biogenic Monoamines'}, {'id': 'D001679', 'term': 'Biogenic Amines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'This study employs a double-blind design. The participant and investigator will all be blind to the order of substance administration during the dosing sessions. Each participant will undergo two dosing sessions on the same day, one with N,N-Dimethyltryptamine (DMT) at a dosage of 60 mg, and another with a placebo containing 1 mg of DMT. The order of substance administration (DMT or placebo) will be randomized and unknown to all parties involved in the study until data collection is complete to ensure unbiased results'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'This is a double-blind, randomized, placebo-controlled crossover design. 25 participants will be evaluated, who will undergo two dosing sessions on the same day: with DMT (60 mg, inhaled) and with placebo (1 mg DMT, inhaled). Each session will last approximately 2 hours, the substance order will be randomized.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-07-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-10', 'studyFirstSubmitDate': '2023-05-22', 'studyFirstSubmitQcDate': '2023-06-02', 'lastUpdatePostDateStruct': {'date': '2023-10-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Systolic Blood Pressure', 'timeFrame': 'up to 2 hours', 'description': 'Assessed 7 times on each session'}, {'measure': 'Diastolic Blood Pressure', 'timeFrame': 'up to 2 hours', 'description': 'Assessed 7 times on each session'}, {'measure': 'Heart rate', 'timeFrame': 'up to 2 hours', 'description': 'Assessed 7 times on each session'}, {'measure': 'Respiratory rate', 'timeFrame': 'up to 2 hours', 'description': 'Assessed 7 times on each session'}, {'measure': 'Oxygen saturation', 'timeFrame': 'up to 2 hours', 'description': 'Assessed 7 times on each session'}], 'secondaryOutcomes': [{'measure': 'Plasma level of glucose', 'timeFrame': 'up to 2 hours', 'description': 'Assessed 2 times on each session'}, {'measure': 'Plasma level of total cholesterol', 'timeFrame': 'up to 2 hours', 'description': 'Assessed 2 times on each session'}, {'measure': 'Plasma level of C-reactive protein (CRP)', 'timeFrame': 'up to 2 hours', 'description': 'Assessed 2 times on each session'}, {'measure': 'Plasma level of urea', 'timeFrame': 'up to 2 hours', 'description': 'Assessed 2 times on each session'}, {'measure': 'Plasma level of creatinine', 'timeFrame': 'up to 2 hours', 'description': 'Assessed 2 times on each session'}, {'measure': 'Plasma level of aspartate transaminase (AST)', 'timeFrame': 'up to 2 hours', 'description': 'Assessed 2 times on each session'}, {'measure': 'Plasma level of alanine transaminase (ALT)', 'timeFrame': 'up to 2 hours', 'description': 'Assessed 2 times on each session'}, {'measure': 'Plasma level of cortisol', 'timeFrame': 'up to 2 hours', 'description': 'Assessed 2 times on each session'}, {'measure': 'Plasma level of subjective effects of DMT', 'timeFrame': 'up to 2 hours', 'description': 'Assessed 2 times on each session'}, {'measure': 'Evaluate the subjective effects of DMT', 'timeFrame': 'up to 2 hours', 'description': 'Assessment of the acute subjective effects of DMT, compared to placebo, by 5D-ASC (5 Dimensions- Altered States of consciousness). Scores range from 0 to 94, where higher scores indicate more intense psychedelic subjective effects.'}, {'measure': 'Evaluate the subjective effects of DMT', 'timeFrame': 'up to 2 hours', 'description': 'Assessment of the acute subjective effects of DMT, compared to placebo, by HRS (Hallucinogen Rating Scale). Scores range from 0 to 400, where higher scores indicate more intense psychedelic subjective effects.'}, {'measure': 'Evaluate the subjective effects of DMT', 'timeFrame': 'up to 2 hours', 'description': 'Assessment of the acute subjective effects of DMT, compared to placebo, by MEQ (Questionnaire of Mystical Experiences). Scores range from 0 to 150, where higher scores indicate more intense psychedelic subjective effects.'}, {'measure': 'Evaluate acute effects on alpha waves using electroencephalography before, during and after the dosing', 'timeFrame': 'up to 1 hours', 'description': 'Assessment of the electrical cerebral activity in different bandwidth as alpha waves by EEG before, during and after each session.'}, {'measure': 'Evaluate acute effects on beta waves using electroencephalography before, during and after the dosing', 'timeFrame': 'up to 1 hours', 'description': 'Assessment of the electrical cerebral activity in different bandwidth as beta waves by EEG before, during and after each session.'}, {'measure': 'Evaluate acute effects on theta waves using electroencephalography before, during and after the dosing', 'timeFrame': 'up to 1 hours', 'description': 'Assessment of the electrical cerebral activity in different bandwidth as theta waves by EEG before, during and after each session.'}, {'measure': 'Evaluate the subacute effects of DMT, compared to placebo, on electroencephalography markers', 'timeFrame': 'up to 0.5 hours', 'description': 'Assessment of the subacute effects of DMT on EEG, including ERP (event-related potential ) generated from visual and auditory stimulation by applying a visual and auditory perception and imagination task.'}, {'measure': 'Evaluate the acute effects of DMT, compared to placebo, on electroencephalography markers', 'timeFrame': 'up to 0.5 hours', 'description': 'Assessment of the acute effects of DMT in ERP (event-related potential) generated from auditory stimulation in an oddball protocol.'}, {'measure': 'Evaluate the subacute effects of DMT on suggestibility', 'timeFrame': 'up to 1 hours', 'description': 'Assessment of the subacute effects of DMT on suggestibility by applying a suggestibility task named Creative Imagination Scale (CIS). Scores range from 0 to 40. Higher scores indicate more intense suggestibility.'}, {'measure': 'Evaluate the influence of expectations', 'timeFrame': 'up to 0.5 hours', 'description': 'Assessment of the influence of expectations variables on subjective experience'}, {'measure': 'Evaluate the influence of personality trait', 'timeFrame': 'up to 0.5 hours', 'description': 'Assessment of the influence of personality trait on suggestibility'}, {'measure': 'Assess DMT Plasma Concentration-Time Profile using High-performance liquid chromatography', 'timeFrame': 'up to 50 minutes', 'description': 'Evaluate changes in serum DMT concentration over time measured in baseline, 2 and 50 minutes after each session.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['N,N-DMT', 'N,N-Dimethyltryptamine', 'DMT', 'placebo', 'psychedelic'], 'conditions': ['Safety Issues', 'Healthy Volunteers']}, 'referencesModule': {'references': [{'pmid': '40532423', 'type': 'DERIVED', 'citation': 'Wiessner I, Falchi-Carvalho M, Laborde S, Barros H, Bolcont R, Ruschi Silva S, Pantrigo E, Medina M, Arichelle F, Almeida R, Aires R, Nunes Ferreira LF, Dantas Correa L, Da Costa Bezerra RB, Thie K, Silva-Costa N, de Araujo Costa Neto LA, Jales Lima de Queiroz MV, Galvao-Coelho N, Araujo D, Palhano-Fontes F. Safety, tolerability and subjective effects of vaporized N,N-Dimethyltryptamine: A randomized double-blind clinical trial. Eur Neuropsychopharmacol. 2025 Aug;97:16-27. doi: 10.1016/j.euroneuro.2025.06.002. Epub 2025 Jun 17.'}], 'seeAlsoLinks': [{'url': 'https://www.gov.br/ebserh/pt-br/hospitais-universitarios/regiao-nordeste/huol-ufrn', 'label': 'Hospital Universitário Onofre Lopes - UFRN (Federal University of Rio Grande do Norte)'}]}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the acute and subacute effects of an inhaled N, N-Dimethyltryptamine (DMT) in healthy individuals.', 'detailedDescription': 'This is a double-blind, randomized, placebo-controlled crossover design. 25 participants will be evaluated, who will undergo two dosing sessions on the same day: with DMT (60 mg, inhaled) and with placebo (1 mg DMT, inhaled). Each session will last approximately 2 hours; the substance order will be randomized.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* previous experience with DMT\n* be right-handed\n* healthy volunteers\n\nExclusion Criteria:\n\n* heart failure\n* liver failure\n* kidney failure\n* uncontrolled high blood pressure\n* history of heart rhythm disorders\n* history of valvular heart disease\n* history of chronic obstructive pulmonary disease (COPD)\n* active or in treatment for bronchial asthma\n* severe obesity\n* coagulation disorders\n* clinical evidence or history of increased intracranial\n* clinical evidence or history of cerebrospinal pressure\n* history or reports of epilepsy\n* severe neurological disease,\n* pregnancy\n* reported or clinically recognized thyroid disorders\n* diagnosis or family suspicion of genetic monoamine deficiency oxidase\n* previous adverse response to psychedelic substances\n* symptoms or family members with a present or past psychotic disorder\n* dissociative identity disorder\n* bipolar affective disorder\n* prodromal symptoms of schizophrenia\n* problematic use or abuse of alcohol or other psychoactive substances (except tobacco)\n* acute or subacute risk of suicide\n* acute flu symptoms\n* symptoms of airway infection\n* contact with a confirmed case of COVID-19 (SARS-CoV-2) in the last 7 days'}, 'identificationModule': {'nctId': 'NCT05901012', 'briefTitle': 'Safety and Tolerability of DMT in Healthy Adults', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Federal do Rio Grande do Norte'}, 'officialTitle': 'Inhaled N,N-Dimethyltryptamine: a Safety and Tolerability Study in Healthy Adults', 'orgStudyIdInfo': {'id': 'DMTcog'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '60mg of N,N-Dimethyltryptamine', 'description': 'One inhaled dose of 60mg of vaporized DMT.', 'interventionNames': ['Drug: N,N-Dimethyltryptamine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo-like', 'description': 'One inhaled dose of 1mg of vaporized DMT.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'N,N-Dimethyltryptamine', 'type': 'DRUG', 'otherNames': ['DMT'], 'description': 'DMT will be administered using a vaporizer device in a placebo-controlled, double-blind, randomized, monocentric clinical trial design.', 'armGroupLabels': ['60mg of N,N-Dimethyltryptamine']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'DMT will be administered using a vaporizer device in a placebo-controlled, double-blind, randomized, monocentric clinical trial design.', 'armGroupLabels': ['Placebo-like']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59012300', 'city': 'Natal', 'state': 'Rio Grande do Norte', 'country': 'Brazil', 'facility': 'Hospital Universitário Onofre Lopes', 'geoPoint': {'lat': -5.795, 'lon': -35.20944}}], 'overallOfficials': [{'name': 'Draulio B. Araujo, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidade Federal do Rio Grande do Norte'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Federal do Rio Grande do Norte', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Draulio Barros de Araujo', 'investigatorAffiliation': 'Universidade Federal do Rio Grande do Norte'}}}}