Safety, Tolerability, and Efficacy of Sublingual Microdoses of 5-MeO-DMT for Depression and Anxiety
NCT ID: NCT06816667
Last Updated: 2025-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
40 participants
INTERVENTIONAL
2024-10-21
2025-03-01
Brief Summary
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Study Design and Objectives:
Participants are divided into four groups: one receiving a placebo and three receiving different doses of 5-MeO-DMT (6 mg, 9 mg, or 12 mg). Each group comprises 10 participants, totaling 40 individuals. The study administers one dose weekly for four weeks, with comprehensive monitoring at baseline and throughout the trial to track changes in emotional, cognitive, and physical well-being.
Objectives:
Assessing 5-MeO-DMT's impact on anxiety, depression, and emotional well-being. Understanding its pharmacokinetics (absorption, distribution, metabolism, and excretion).
Evaluating its safety profile and identifying potential side effects, both mild and severe.
Monitoring and Safety Participant safety is prioritized, with medical professionals conducting regular evaluations of vital signs, such as heart rate and blood pressure. Detailed tracking of mood, perception, and physical responses ensures any adverse reactions are documented and analyzed.
Sublingual Administration The sublingual route is being studied for its rapid absorption into the bloodstream. Researchers will determine how efficiently the body processes 5-MeO-DMT, its duration in the bloodstream, and its influence on daily life. These findings will inform the practicality of this administration method in clinical settings.
Significance of the Study This trial aims to establish a robust safety and tolerability profile for 5-MeO-DMT while exploring its effects on anxiety and depression. The results will also provide essential data to guide future studies into its therapeutic potential for improving mental health and overall quality of life.
By addressing both the compound's safety and potential benefits, this research lays the groundwork for developing innovative mental health treatments.
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Detailed Description
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Study Objectives
The Phase I component emphasizes:
* Safety and Tolerability: Assessing physiological responses, including vital signs (heart rate, blood pressure, respiration rate, temperature) and cardiac function (ECGs). Biochemical markers of renal, hepatic, and hematological health will be monitored to detect potential adverse effects.
* Pharmacokinetics: Evaluating how 5-MeO-DMT is absorbed, distributed, metabolized, and eliminated through blood sampling at multiple time points. Key metrics include peak plasma concentration (Cmax), time to peak (Tmax), and overall exposure (AUC).
The Phase II component explores the efficacy of 5-MeO-DMT in reducing symptoms of anxiety and depression and enhancing emotional well-being.
Participants and Dosing Regimen The trial enrolls 40 participants aged 40-80, divided into four groups: one placebo group and three active treatment groups receiving sublingual doses of 6 mg, 9 mg, or 12 mg of 5-MeO-DMT. A single weekly dose is administered over four weeks, enabling the evaluation of immediate and cumulative effects.
Recruitment will target healthy volunteers who meet specific anxiety and mood criteria. Notably, participants will be screened to exclude individuals with previous psychedelic experiences involving tryptamines, ergolines, or phenethylamines, those with contraindications to the use of psychedelics, and those currently taking prescribed psychoactive medications. This includes serotonin reuptake inhibitors, benzodiazepines, medications primarily affecting serotonin neurons (e.g., ondansetron), and MAO inhibitors.
Neurocognitive and Psychological Assessments
Participants undergo validated assessments to evaluate changes in:
* Mood and Anxiety: Tools include the State-Trait Anxiety Inventory (STAI), Beck Depression Inventory II (BDI-II), Depression, Anxiety, and Stress Scale (DASS-21), and Suicidal Ideation Scale (SSI).
* Cognitive Function: Neurocognitive tests like the Phonological Verbal Fluency Test (FAS), Paced Auditory Serial Addition Test (PASAT), and Digit Span Scale (DSS) assess executive function, working memory, and attention.
Validated instruments will be employed to evaluate mood, anxiety levels, cognitive function, and any perceptual or psychological effects experienced by participants. These assessments will be conducted at baseline (Week 0), during each dosing week (Weeks 1-4), and at the end of the study (Week 5). By measuring these parameters, the trial aims to identify the effects of sub-psychedelic doses of 5-MeO-DMT on cognitive processes and emotional states.
Safety Protocols The study complies with Good Clinical Practice (GCP) and ethical standards, including approval from the CEI of the Ministry of Health of San Juan, Argentina. Informed consent is obtained from all participants, who are screened to exclude individuals with prior psychedelic experiences, contraindications, or concurrent use of psychoactive medications.
The trial prioritizes participant safety with continuous monitoring and immediate medical response protocols for any adverse events.
Expected Outcomes This study aims to generate a comprehensive dataset on the safety, pharmacokinetics, and potential efficacy of sublingual 5-MeO-DMT, providing a clear and detailed understanding of its safety and tolerability profile under controlled conditions.
The findings are expected to inform future research into the therapeutic potential of 5-MeO-DMT for anxiety, depression, and other mental health disorders, offering critical insights into its clinical applications. By advancing the understanding of psychedelic compounds, this study represents a pivotal step toward developing innovative, evidence-based treatments for mental health challenges.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Phase I focuses on safety and pharmacokinetics, monitoring vital signs, ECGs, and biochemical markers while analyzing parameters like Cmax, Tmax, and AUC. Phase II assesses efficacy in reducing anxiety and depression, measured through validated scales (STAI, BDI-II, DASS-21), alongside neurocognitive assessments (FAS, PASAT).
This trial aims to provide comprehensive data on 5-MeO-DMT's safety, tolerability, and potential therapeutic effects for well being, mood and anxiety disorders.
TREATMENT
TRIPLE
Study Groups
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Arm 1: 6 mg of 5-MeO-DMT Sublingual Administration
In this arm, participants will receive a sublingual dose of 6 mg of 5-MeO-DMT once a week for four consecutive weeks. This dosage is designed to evaluate the safety, tolerability, and potential efficacy of 5-MeO-DMT at a sub-psychedelic level.
Comprehensive monitoring will include assessments of vital signs, adverse reactions, and overall well-being. Psychiatric evaluations, such as the State-Trait Anxiety Inventory (STAI) and Beck Depression Inventory II (BDI-II), will measure changes in anxiety and depression symptoms. Neurocognitive tests will assess functions like attention, working memory, and executive function.
EEG evaluations will explore potential changes in brain activity. The findings from this arm will provide critical insights into the effects of a 6 mg dose on emotional health and cognitive performance, contributing to the understanding of 5-MeO-DMT's therapeutic potential in mood and anxiety disorders without inducing a full psychedelic experience.
BMND08
Participants will receive a sublingual dose of 5-MeO-DMT once a week for four consecutive weeks. The intervention will be administered in the form of a sublingual tablet. The substance 5-MeO-DMT, a potent tryptamine, is known for its psychoactive properties but will be administered at a dose that does not induce a full psychedelic experience.
Brain electrical activity monitor
EEG is a technique used to monitor brain electrical activity by recording brain waves through electrodes placed on the scalp. This procedure allows the assessment of brain waves such as delta, theta, alpha, and beta, specifically to evaluate the changes in brain activity following sublingual administration of 5-MeO-DMT.
Biochemical determinations
Biochemical determinations will be performed to assess hematological, renal, hepatic, cardiac, and cellular lysis functions. The biochemical markers that will be measured include red blood cells, hematocrit, hemoglobin, glycated hemoglobin, white blood cells, microalbuminuria (urine albumin/creatinine ratio), and various serum markers such as cortisol, glucose, urea, serum creatinine, total cholesterol, HDL, LDL, triglycerides, AST, ALT, lactate dehydrogenase (LDH), creatine kinase (CK), CK-MB, and C-reactive protein.
Acute Subjective Ratings of Psychedelic Effects
To determine the intensity of the acute effects experienced by subjects, retrospective ratings will be collected 1 hour after 5-MeO-DMT or placebo exposure. Subjective ratings will include the Peak Experience Scale (PES), the Ego Dissolution Inventory (EDI), and the Mystical Experiences Questionnaire (MEQ).
vital signs
Vital signs, including blood pressure, heart rate, oxygen saturation, respiration rate, body temperature, and electrocardiograms (ECGs), will be monitored over the six weeks of the treatment
Cognitive Assessments
Cognitive assessments will evaluate the effects of sublingual 5-MeO-DMT on cognitive functions. Participants will undergo the Phonological Verbal Fluency Test (FAS) to assess executive function, the Paced Auditory Serial Addition Test (PASAT) to evaluate processing speed, and the Digit Span Scale (DSS) for attention span and working memory. These tests will be administered at baseline, during treatment, and post-treatment to assess any cognitive changes in response to the different doses of 5-MeO-DMT (6 mg, 9 mg, 12 mg) or placebo, helping to determine how the intervention may influence cognitive processing, memory, and attention.
Psychiatric Assessments
Psychiatric evaluations will be conducted to assess the emotional and psychological effects of sublingual 5-MeO-DMT. Participants will complete the Beck Depression Inventory II (BDI II) to measure mood and depressive symptoms, the State-Trait Anxiety Inventory (STAI) to evaluate state anxiety, and the Depression, Anxiety, and Stress Scale (DASS-21) to assess stress levels. Additionally, the Suicidal Ideation Scale (SSI) will be used to monitor any changes in suicidal ideation throughout the study. These psychiatric assessments will be administered at multiple time points during the study to evaluate the potential therapeutic effects of 5-MeO-DMT in improving mood, anxiety, and overall psychological well-being.
Arm 2: 9 mg 5-MeO-DMT Sublingual Administration
In this arm, participants will receive a sublingual dose of 9 mg of 5-MeO-DMT once a week for four consecutive weeks. This dosage is chosen to evaluate the safety, tolerability, and pharmacokinetics of 5-MeO-DMT at a sub-psychedelic level.
Participants will be closely monitored for adverse effects, changes in vital signs, and overall health during the treatment period. Assessments will include validated psychiatric evaluations, such as STAI and BDI-II, to measure changes in anxiety and depressive symptoms. Neurocognitive tests, including DSS, FAS and PASAT, will evaluate processing speed and executive function.
EEG recordings will explore potential changes in brain activity. This arm will provide valuable insights into the emotional and cognitive effects of the 9 mg dose, offering critical information on its therapeutic potential for anxiety and depression while ensuring safety and tolerability without inducing full psychedelic experiences.
BMND08
Participants will receive a sublingual dose of 5-MeO-DMT once a week for four consecutive weeks. The intervention will be administered in the form of a sublingual tablet. The substance 5-MeO-DMT, a potent tryptamine, is known for its psychoactive properties but will be administered at a dose that does not induce a full psychedelic experience.
Brain electrical activity monitor
EEG is a technique used to monitor brain electrical activity by recording brain waves through electrodes placed on the scalp. This procedure allows the assessment of brain waves such as delta, theta, alpha, and beta, specifically to evaluate the changes in brain activity following sublingual administration of 5-MeO-DMT.
Biochemical determinations
Biochemical determinations will be performed to assess hematological, renal, hepatic, cardiac, and cellular lysis functions. The biochemical markers that will be measured include red blood cells, hematocrit, hemoglobin, glycated hemoglobin, white blood cells, microalbuminuria (urine albumin/creatinine ratio), and various serum markers such as cortisol, glucose, urea, serum creatinine, total cholesterol, HDL, LDL, triglycerides, AST, ALT, lactate dehydrogenase (LDH), creatine kinase (CK), CK-MB, and C-reactive protein.
Acute Subjective Ratings of Psychedelic Effects
To determine the intensity of the acute effects experienced by subjects, retrospective ratings will be collected 1 hour after 5-MeO-DMT or placebo exposure. Subjective ratings will include the Peak Experience Scale (PES), the Ego Dissolution Inventory (EDI), and the Mystical Experiences Questionnaire (MEQ).
vital signs
Vital signs, including blood pressure, heart rate, oxygen saturation, respiration rate, body temperature, and electrocardiograms (ECGs), will be monitored over the six weeks of the treatment
Cognitive Assessments
Cognitive assessments will evaluate the effects of sublingual 5-MeO-DMT on cognitive functions. Participants will undergo the Phonological Verbal Fluency Test (FAS) to assess executive function, the Paced Auditory Serial Addition Test (PASAT) to evaluate processing speed, and the Digit Span Scale (DSS) for attention span and working memory. These tests will be administered at baseline, during treatment, and post-treatment to assess any cognitive changes in response to the different doses of 5-MeO-DMT (6 mg, 9 mg, 12 mg) or placebo, helping to determine how the intervention may influence cognitive processing, memory, and attention.
Psychiatric Assessments
Psychiatric evaluations will be conducted to assess the emotional and psychological effects of sublingual 5-MeO-DMT. Participants will complete the Beck Depression Inventory II (BDI II) to measure mood and depressive symptoms, the State-Trait Anxiety Inventory (STAI) to evaluate state anxiety, and the Depression, Anxiety, and Stress Scale (DASS-21) to assess stress levels. Additionally, the Suicidal Ideation Scale (SSI) will be used to monitor any changes in suicidal ideation throughout the study. These psychiatric assessments will be administered at multiple time points during the study to evaluate the potential therapeutic effects of 5-MeO-DMT in improving mood, anxiety, and overall psychological well-being.
Arm 3: 12 mg 5-MeO-DMT Sublingual Administration
In this arm, participants will receive a sublingual dose of 12 mg of 5-MeO-DMT once a week for four consecutive weeks. This higher dose is designed to evaluate the safety, tolerability, and pharmacokinetics of 5-MeO-DMT at a level that remains below the threshold for inducing full psychedelic experiences.
Participants will be closely monitored for adverse effects, changes in vital signs, and overall health during the treatment period. Detailed psychiatric assessments, including the STAI, BDI-II and DASS-21 will be used to measure changes in anxiety, depression, and emotional well-being. Neurocognitive tests, such as the FAS, PASAT and Digit Symbol, to evaluate attention, working memory, and processing speed.
Additionally, EEG evaluations will explore potential changes in brain activity. Data from this arm will provide critical insights into the therapeutic potential of the 12 mg dose for reducing mood and anxiety symptoms while ensuring safety and maintaining tolerability.
BMND08
Participants will receive a sublingual dose of 5-MeO-DMT once a week for four consecutive weeks. The intervention will be administered in the form of a sublingual tablet. The substance 5-MeO-DMT, a potent tryptamine, is known for its psychoactive properties but will be administered at a dose that does not induce a full psychedelic experience.
Brain electrical activity monitor
EEG is a technique used to monitor brain electrical activity by recording brain waves through electrodes placed on the scalp. This procedure allows the assessment of brain waves such as delta, theta, alpha, and beta, specifically to evaluate the changes in brain activity following sublingual administration of 5-MeO-DMT.
Pharmacokinetic Study of Sublingually Administered Psychoactive Substance
For pharmacokinetic analysis, approximately 6 mL of EDTA blood will be collected to assess the pharmacokinetics of a sublingual dose of 5-MeO-DMT. Samples will be obtained at baseline (pre-dose, 0 minutes) and at the following time points post-dose: 5, 10, 20, 30, 40, 50, 60, and 120 minutes.
Biochemical determinations
Biochemical determinations will be performed to assess hematological, renal, hepatic, cardiac, and cellular lysis functions. The biochemical markers that will be measured include red blood cells, hematocrit, hemoglobin, glycated hemoglobin, white blood cells, microalbuminuria (urine albumin/creatinine ratio), and various serum markers such as cortisol, glucose, urea, serum creatinine, total cholesterol, HDL, LDL, triglycerides, AST, ALT, lactate dehydrogenase (LDH), creatine kinase (CK), CK-MB, and C-reactive protein.
Acute Subjective Ratings of Psychedelic Effects
To determine the intensity of the acute effects experienced by subjects, retrospective ratings will be collected 1 hour after 5-MeO-DMT or placebo exposure. Subjective ratings will include the Peak Experience Scale (PES), the Ego Dissolution Inventory (EDI), and the Mystical Experiences Questionnaire (MEQ).
vital signs
Vital signs, including blood pressure, heart rate, oxygen saturation, respiration rate, body temperature, and electrocardiograms (ECGs), will be monitored over the six weeks of the treatment
Cognitive Assessments
Cognitive assessments will evaluate the effects of sublingual 5-MeO-DMT on cognitive functions. Participants will undergo the Phonological Verbal Fluency Test (FAS) to assess executive function, the Paced Auditory Serial Addition Test (PASAT) to evaluate processing speed, and the Digit Span Scale (DSS) for attention span and working memory. These tests will be administered at baseline, during treatment, and post-treatment to assess any cognitive changes in response to the different doses of 5-MeO-DMT (6 mg, 9 mg, 12 mg) or placebo, helping to determine how the intervention may influence cognitive processing, memory, and attention.
Psychiatric Assessments
Psychiatric evaluations will be conducted to assess the emotional and psychological effects of sublingual 5-MeO-DMT. Participants will complete the Beck Depression Inventory II (BDI II) to measure mood and depressive symptoms, the State-Trait Anxiety Inventory (STAI) to evaluate state anxiety, and the Depression, Anxiety, and Stress Scale (DASS-21) to assess stress levels. Additionally, the Suicidal Ideation Scale (SSI) will be used to monitor any changes in suicidal ideation throughout the study. These psychiatric assessments will be administered at multiple time points during the study to evaluate the potential therapeutic effects of 5-MeO-DMT in improving mood, anxiety, and overall psychological well-being.
Arm 4: Placebo Sublingual Administration
Participants in this arm will receive a placebo formulation administered sublingually once a week for four consecutive weeks. The placebo is designed to be indistinguishable from the active 5-MeO-DMT formulations in appearance, taste, and administration method, ensuring that both participants and investigators remain blinded to treatment allocations.
Participants will undergo the same evaluations as those in the active treatment arms. These assessments include psychiatric evaluations (STAI, BDI-II, and DASS-21), and neurocognitive tests to measure attention, memory, and processing speed. EEG evaluations will also be performed to explore potential changes in brain activity.
This arm serves as the baseline comparator, allowing for the differentiation of the specific therapeutic effects of 5-MeO-DMT from potential placebo effects. The findings will help establish the safety and efficacy of the active compound in reducing symptoms of anxiety and depression.
BMND08
Participants will receive a sublingual dose of 5-MeO-DMT once a week for four consecutive weeks. The intervention will be administered in the form of a sublingual tablet. The substance 5-MeO-DMT, a potent tryptamine, is known for its psychoactive properties but will be administered at a dose that does not induce a full psychedelic experience.
Brain electrical activity monitor
EEG is a technique used to monitor brain electrical activity by recording brain waves through electrodes placed on the scalp. This procedure allows the assessment of brain waves such as delta, theta, alpha, and beta, specifically to evaluate the changes in brain activity following sublingual administration of 5-MeO-DMT.
Biochemical determinations
Biochemical determinations will be performed to assess hematological, renal, hepatic, cardiac, and cellular lysis functions. The biochemical markers that will be measured include red blood cells, hematocrit, hemoglobin, glycated hemoglobin, white blood cells, microalbuminuria (urine albumin/creatinine ratio), and various serum markers such as cortisol, glucose, urea, serum creatinine, total cholesterol, HDL, LDL, triglycerides, AST, ALT, lactate dehydrogenase (LDH), creatine kinase (CK), CK-MB, and C-reactive protein.
Acute Subjective Ratings of Psychedelic Effects
To determine the intensity of the acute effects experienced by subjects, retrospective ratings will be collected 1 hour after 5-MeO-DMT or placebo exposure. Subjective ratings will include the Peak Experience Scale (PES), the Ego Dissolution Inventory (EDI), and the Mystical Experiences Questionnaire (MEQ).
vital signs
Vital signs, including blood pressure, heart rate, oxygen saturation, respiration rate, body temperature, and electrocardiograms (ECGs), will be monitored over the six weeks of the treatment
Cognitive Assessments
Cognitive assessments will evaluate the effects of sublingual 5-MeO-DMT on cognitive functions. Participants will undergo the Phonological Verbal Fluency Test (FAS) to assess executive function, the Paced Auditory Serial Addition Test (PASAT) to evaluate processing speed, and the Digit Span Scale (DSS) for attention span and working memory. These tests will be administered at baseline, during treatment, and post-treatment to assess any cognitive changes in response to the different doses of 5-MeO-DMT (6 mg, 9 mg, 12 mg) or placebo, helping to determine how the intervention may influence cognitive processing, memory, and attention.
Psychiatric Assessments
Psychiatric evaluations will be conducted to assess the emotional and psychological effects of sublingual 5-MeO-DMT. Participants will complete the Beck Depression Inventory II (BDI II) to measure mood and depressive symptoms, the State-Trait Anxiety Inventory (STAI) to evaluate state anxiety, and the Depression, Anxiety, and Stress Scale (DASS-21) to assess stress levels. Additionally, the Suicidal Ideation Scale (SSI) will be used to monitor any changes in suicidal ideation throughout the study. These psychiatric assessments will be administered at multiple time points during the study to evaluate the potential therapeutic effects of 5-MeO-DMT in improving mood, anxiety, and overall psychological well-being.
Interventions
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BMND08
Participants will receive a sublingual dose of 5-MeO-DMT once a week for four consecutive weeks. The intervention will be administered in the form of a sublingual tablet. The substance 5-MeO-DMT, a potent tryptamine, is known for its psychoactive properties but will be administered at a dose that does not induce a full psychedelic experience.
Brain electrical activity monitor
EEG is a technique used to monitor brain electrical activity by recording brain waves through electrodes placed on the scalp. This procedure allows the assessment of brain waves such as delta, theta, alpha, and beta, specifically to evaluate the changes in brain activity following sublingual administration of 5-MeO-DMT.
Pharmacokinetic Study of Sublingually Administered Psychoactive Substance
For pharmacokinetic analysis, approximately 6 mL of EDTA blood will be collected to assess the pharmacokinetics of a sublingual dose of 5-MeO-DMT. Samples will be obtained at baseline (pre-dose, 0 minutes) and at the following time points post-dose: 5, 10, 20, 30, 40, 50, 60, and 120 minutes.
Biochemical determinations
Biochemical determinations will be performed to assess hematological, renal, hepatic, cardiac, and cellular lysis functions. The biochemical markers that will be measured include red blood cells, hematocrit, hemoglobin, glycated hemoglobin, white blood cells, microalbuminuria (urine albumin/creatinine ratio), and various serum markers such as cortisol, glucose, urea, serum creatinine, total cholesterol, HDL, LDL, triglycerides, AST, ALT, lactate dehydrogenase (LDH), creatine kinase (CK), CK-MB, and C-reactive protein.
Acute Subjective Ratings of Psychedelic Effects
To determine the intensity of the acute effects experienced by subjects, retrospective ratings will be collected 1 hour after 5-MeO-DMT or placebo exposure. Subjective ratings will include the Peak Experience Scale (PES), the Ego Dissolution Inventory (EDI), and the Mystical Experiences Questionnaire (MEQ).
vital signs
Vital signs, including blood pressure, heart rate, oxygen saturation, respiration rate, body temperature, and electrocardiograms (ECGs), will be monitored over the six weeks of the treatment
Cognitive Assessments
Cognitive assessments will evaluate the effects of sublingual 5-MeO-DMT on cognitive functions. Participants will undergo the Phonological Verbal Fluency Test (FAS) to assess executive function, the Paced Auditory Serial Addition Test (PASAT) to evaluate processing speed, and the Digit Span Scale (DSS) for attention span and working memory. These tests will be administered at baseline, during treatment, and post-treatment to assess any cognitive changes in response to the different doses of 5-MeO-DMT (6 mg, 9 mg, 12 mg) or placebo, helping to determine how the intervention may influence cognitive processing, memory, and attention.
Psychiatric Assessments
Psychiatric evaluations will be conducted to assess the emotional and psychological effects of sublingual 5-MeO-DMT. Participants will complete the Beck Depression Inventory II (BDI II) to measure mood and depressive symptoms, the State-Trait Anxiety Inventory (STAI) to evaluate state anxiety, and the Depression, Anxiety, and Stress Scale (DASS-21) to assess stress levels. Additionally, the Suicidal Ideation Scale (SSI) will be used to monitor any changes in suicidal ideation throughout the study. These psychiatric assessments will be administered at multiple time points during the study to evaluate the potential therapeutic effects of 5-MeO-DMT in improving mood, anxiety, and overall psychological well-being.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must provide written informed consent to participate in the study.
* Participants must exhibit moderate to high levels of anxiety and/or depression:
* Anxiety levels assessed using the State-Trait Anxiety Inventory (STAI):
* STAI-S (State) score of ≥20 for men and ≥23 for women
* STAI-T (Trait) score of ≥20 for men and ≥26 for women
* Depression levels assessed using the Beck Depression Inventory (BDI):
* BDI score of ≥21 indicating the presence of moderate to severe depressive symptoms.
* Participants may meet the criteria for either anxiety, depression, or both, as long as they meet the respective thresholds for each
Exclusion Criteria
* Cardiovascular conditions, including: Uncontrolled hypertension, Angina, Clinically significant ECG abnormalities (e.g., atrial fibrillation), Transient ischemic attack (TIA) within the last 6 months.
* Stroke or peripheral/pulmonary vascular disease without active claudication.
* Blood pressure exceeding 140 mmHg systolic or 90 mmHg diastolic.
* Epilepsy or a history of seizures.
* Kidney failure.
* Insulin-dependent diabetes.
* Chronic obstructive pulmonary disease (COPD).
* Increased intracranial or cerebrospinal pressure
* Hyperthyroidism
* Psychotic symptoms or a family history of psychotic disorders
* Prodromal symptoms of schizophrenia or dissociative identity disorder.
* Severe symptoms of depression or anxiety requiring immediate treatment with antidepressants or daily anxiolytic medications, especially in cases involving suicidal ideation.
* Medications: Regular use of prescribed psychoactive medications, such as: Benzodiazepines, Medications affecting serotonin neurons (e.g., ondansetron), Monoamine oxidase inhibitors (MAOIs).
* Drug Interactions: Use of potent metabolic inducers or inhibitors, including: Inducers: Rifampicin (rifabutin, rifapentine), anticonvulsants (carbamazepine, phenytoin, phenobarbital), nevirapine, efavirenz, taxol, dexamethasone. or Inhibitors: All HIV protease inhibitors, itraconazole, ketoconazole, erythromycin, clarithromycin, and troleandomycin.
40 Years
80 Years
ALL
Yes
Sponsors
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Biomind Labs Inc.
INDUSTRY
Hospital Descentralizado Dr. Marcial V. Quiroga
UNKNOWN
Universidad Católica de Cuyo
UNKNOWN
Responsible Party
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Principal Investigators
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Martin A. Bruno, PhD
Role: PRINCIPAL_INVESTIGATOR
Biomind Labs Inc.
Locations
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Hospital Descentralizado Dr. Marcial V. Quiroga.
San Juan, Rivadavia, Argentina
Countries
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References
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Bistue Millon MB, Noguera L, Bruno D, Vita L, Zanino M, Kassuha DE, Ortiz JE, Feresin GE, Diaz-Dellavalle P, Orosco L, Garces MA, Diez P, Albarracin SG, Bruno MA. Safety and tolerability of multiple sublingual microdoses of 5-MeO-DMT in adults with moderate symptoms of depression and/or anxiety: a randomized, double-blind, placebo-controlled study. Neuropsychopharmacology. 2025 Oct;50(11):1715-1723. doi: 10.1038/s41386-025-02167-3. Epub 2025 Jul 15.
Related Links
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Biomind Labs is developing the next generation of pharmaceuticals to treat patients suffering from neurological disorders. This unique approach targets the original and initial drivers of the diseases.
Other Identifiers
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BMND08-01
Identifier Type: -
Identifier Source: org_study_id
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