Ignite Creation Date:
2025-12-24 @ 5:46 PM
Ignite Modification Date:
2025-12-29 @ 10:46 PM
Study NCT ID:
NCT05573568
Status:
COMPLETED
Last Update Posted:
2023-02-15
First Post:
2022-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study of DMT in Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-01-25', 'releaseDate': '2023-05-05'}], 'estimatedResultsFirstSubmitDate': '2023-05-05'}}, '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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-11-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-13', 'studyFirstSubmitDate': '2022-10-06', 'studyFirstSubmitQcDate': '2022-10-06', 'lastUpdatePostDateStruct': {'date': '2023-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Treatment-Emergent Adverse Events as clinical and psychiatry symptoms assessed by qualitative medical/clinical-psychiatry evaluation', 'timeFrame': 'up to 1 month after dosing', 'description': 'Evaluate clinical and psychiatry acute risks after DMT treatments assessed by qualitative medical evaluation after dosing.'}, {'measure': 'Blood Pressure', 'timeFrame': 'up to 2 hours after each dose', 'description': 'Assessed 20 times on each dose via systolic and diastolic blood pressure'}, {'measure': 'Heart rate', 'timeFrame': 'up to 2 hours after each dose', 'description': 'Assessed 20 times on each dose'}, {'measure': 'Respiratory rate', 'timeFrame': 'up to 2 hours after each dose', 'description': 'Assessed 20 times on each dose'}, {'measure': 'Oxygen saturation', 'timeFrame': 'up to 2 hours after each dose', 'description': 'Assessed 20 times on each dose'}], 'secondaryOutcomes': [{'measure': 'Plasma level of glucose', 'timeFrame': 'up to 2 hours after each dose', 'description': 'Assessed 2 times on each dose'}, {'measure': 'Plasma level of total cholesterol', 'timeFrame': 'up to 2 hours after each dose', 'description': 'Assessed 2 times on each dose'}, {'measure': 'Plasma level of C-reactive protein (CRP)', 'timeFrame': 'up to 2 hours after each dose', 'description': 'Assessed 2 times on each dose'}, {'measure': 'Plasma level of urea', 'timeFrame': 'up to 2 hours after each dose', 'description': 'Assessed 2 times on each dose'}, {'measure': 'Plasma level of creatinine', 'timeFrame': 'up to 2 hours after each dose', 'description': 'Assessed 2 times on each dose'}, {'measure': 'Plasma level of aspartate transaminase (AST)', 'timeFrame': 'up to 2 hours after each dose', 'description': 'Assessed 2 times on each dose'}, {'measure': 'Plasma level of alanine transaminase (ALT)', 'timeFrame': 'up to 2 hours after each dose', 'description': 'Assessed 2 times on each dose'}, {'measure': 'Plasma level of cortisol', 'timeFrame': 'up to 2 hours after each dose', 'description': 'Assessed 2 times on each dose'}, {'measure': 'Evaluate the subjective effects of DMT', 'timeFrame': 'up to 2 hours after each dose', 'description': 'Assessment of the acute subjective effects of DMT by Hallucinogen Rating Scale (HRS) after each dosing. Higher scores indicate more intense psychedelic subjective effects.'}, {'measure': 'Evaluate acute effects on cerebral activity using electroencephalography before, during and after the dosing', 'timeFrame': 'up to 2 hours after each dose', 'description': 'Assessment of the electrical cerebral activity in different bandwidth as alpha, beta, theta waves by EEG before, during and after each dosing.'}, {'measure': 'Assess DMT Plasma Concentration-Time Profile using High-performance liquid chromatography', 'timeFrame': 'up to 2 hours after each dose', 'description': 'Evaluate changes in serum DMT concentration over time measured in 2, 5, 10, 15 and 120 minutes after each dosing.'}, {'measure': 'Evaluate the impact of after DMT on satisfaction with life using scale', 'timeFrame': 'up to 1 month after dosing', 'description': 'Assessment of satisfaction with life in different time points as baseline, 1, 2, 7, 14 and 28 days after dosing using the Satisfaction with Life Scale (SWL). Scores ranging from 5 to 35. Higher scores indicate greater satisfaction with life.'}, {'measure': 'Evaluate the impact of DMT on trait and state of anxiety using scale', 'timeFrame': 'up to 1 month after dosing', 'description': 'Assessment of trait and state anxiety in different time points as baseline, 1, 2, 7, 14 and 28 days after dosing using the State-Trait Anxiety Inventory (STAI). Scores ranging from 0 to 63. Higher scores indicate more severe anxiety.'}, {'measure': 'Evaluate the impact of DMT on quality of life using scale', 'timeFrame': 'up to 1 month after dosing', 'description': 'Assessment of quality of life in different time points as baseline, 14 and 28 days after dosing using the questionnaires World Health Organization Quality of Life Assessment Instrument (WHOQOL-BREF). Scores ranging from 0 to 100.\n\nHigher scores indicate better quality of life.'}, {'measure': 'Evaluate the impact of DMT on spirituality, religiousness and personal beliefs', 'timeFrame': 'up to 1 month after dosing', 'description': 'Assessment of spirituality, religiousness and personal beliefs in different time points as baseline, 14 and 28 days after dosing using the World Health Organization Quality of Life Assessment Instrument for Spirituality, Religiousness and Personal Beliefs (WHOQOL-SRPB). The scale is divided in 8 domains, scores ranging from 4 to 20 in each domain.\n\nHigher levels indicate higher level of spirituality, religiousness and personal beliefs.'}, {'measure': 'Evaluate the impact of DMT on affect using scale', 'timeFrame': 'up to 1 month after dosing', 'description': 'Assessment of affect in different time points as baseline, 1, 2, 7, 14 and 28 days after dosing using the questionnaire Positive and Negative Affect Schedule (PANAS). To score the positive affect items 1, 3, 5, 9, 10, 12, 14, 16, 17 and 19 are summed up. Scores ranging from 10 to 50. Higher scores indicate higher levels of positive affect. To score the negative affect items 2, 4, 6, 7, 8, 11, 13, 15, 18 and 20 are summed up. Scores ranging from 10 to 50. Higher scores indicate higher levels of negative affect'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['N,N-DMT', 'DMT', 'N,N-Dimethyltryptamine', 'Healthy Volunteers'], 'conditions': ['Healthy Volunteers']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://biomindlabs.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the acute and subacute effects of an inhaled N, N-Dimethyltryptamine in healthy individuals.', 'detailedDescription': 'Participants will receive N, N-Dimethyltryptamine administered in two dosing sessions: an initial low-dose safety session and subsequent intermediate-dose treatment, in a fixed order and 2h apart.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* prior experience with N,N-Dimethyltryptamine (DMT)\n* present proof of vaccination against COVID-19 (Coronavírus)\n\nExclusion Criteria:\n\n* heart failure\n* liver failure\n* kidney failure\n* resistant hypertension\n* arrhythmia\n* valvular heart disease\n* chronic obstructive pulmonary disease\n* asthma\n* severe obesity\n* epilepsy\n* pregnancy\n* thyroid disorders\n* family diagnosis or suspicion of genetic monoamine oxidase deficiency\n* previous adverse response to psychedelic substances\n* present or past symptoms or family members with a psychotic disorder\n* dissociative identity disorder\n* bipolar disorder\n* prodromal symptoms of schizophrenia\n* abuse of alcohol or other psychoactive substances, except tobacco\n* acute or sub-acute risk of suicide\n* flu-like symptoms'}, 'identificationModule': {'nctId': 'NCT05573568', 'briefTitle': 'Clinical Study of DMT in Healthy Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biomind Labs Inc.'}, 'officialTitle': 'Inhaled N, N-Dimethyltryptamine: a Phase I Study in Healthy Adults', 'orgStudyIdInfo': {'id': 'BMND01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A - single ascending dose', 'description': 'Administration of up to 2 inhaled doses of DMT within a single day (5 mg, followed by 20 mg) with a 2-hour dose interval (5 subjects).', 'interventionNames': ['Drug: N,N-Dimethyltryptamine']}, {'type': 'EXPERIMENTAL', 'label': 'Group B - single ascending dose', 'description': 'Administration of up to 2 inhaled doses of DMT within a single day (7.5 mg, followed by 30 mg) with a 2-hour dose interval (5 subjects).', 'interventionNames': ['Drug: N,N-Dimethyltryptamine']}, {'type': 'EXPERIMENTAL', 'label': 'Group C - single ascending dose', 'description': 'Administration of up to 2 inhaled doses of DMT within a single day (10 mg, followed by 40 mg) with a 2-hour dose interval (5 subjects).', 'interventionNames': ['Drug: N,N-Dimethyltryptamine']}, {'type': 'EXPERIMENTAL', 'label': 'Group D - single ascending dose', 'description': 'Administration of up to 2 inhaled doses of DMT within a single day (12.5 mg, followed by 50 mg) with a 2-hour dose interval (5 subjects).', 'interventionNames': ['Drug: N,N-Dimethyltryptamine']}, {'type': 'EXPERIMENTAL', 'label': 'Group E - single ascending dose', 'description': 'Administration of up to 2 inhaled doses of DMT within a single day (15 mg, followed by 60 mg) with a 2-hour dose interval (5 subjects).', 'interventionNames': ['Drug: N,N-Dimethyltryptamine']}], 'interventions': [{'name': 'N,N-Dimethyltryptamine', 'type': 'DRUG', 'otherNames': ['DMT', 'BMND01'], 'description': 'DMT will be administered using a vaporizer device in a single ascending fixed-order dosing regimen', 'armGroupLabels': ['Group A - single ascending dose', 'Group B - single ascending dose', 'Group C - single ascending dose', 'Group D - single ascending dose', 'Group E - single ascending dose']}]}, '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}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biomind Labs Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Universidade Federal do Rio Grande do Norte', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-05-05', 'type': 'RELEASE'}, {'date': '2024-01-25', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Biomind Labs Inc.'}}}}