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This study measures the safety and efficacy of repeated low dose MM120 as treatment for ADHD in adults: a multi-center, randomized, double-blind, placebo-controlled
This study is a multi-center, randomized, double-blind, placebo-controlled Phase 2a study of low dose MM120 (20 μg) compared with a placebo administered for 6 weeks (twice a week on a 3/4-day schedule).
Low dose MM120 (20 μg) is about 20% of the dose typically consumed for recreational psychedelic purposes.
There will be a 1:1 randomization, double-blind, to MM120 or placebo with the aim to reach 26 evaluable patients in each of the 2 arms at Week 6.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1- Placebo | Placebo Comparator | A total of 26 patients will receive a placebo identical in appearance to the investigational medicinal product (IMP) administered orally twice weekly (e.g., Tuesday/Friday) for 6 weeks. |
|
| Arm 2- MM120 | Experimental | A total of 26 patients will receive 20 μg of MM120 administered orally twice weekly for 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MM120 | Drug | MM120 is a psychedelic drug that can cause intensified thoughts, emotions, and sensory perception. At sufficiently high dosages MM120 manifests primarily visual, as well as auditory, hallucinations. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Symptoms | The Adult ADHD investigator symptom rating scale (AISRS) total score consists of 18 items from the original Attention-deficit/hyperactivity Disorder Rating Scale (ADHD-RS). The ADHD-RS includes 9 items that address symptoms of inattention, and 9 items that address symptoms of impulsivity and hyperactivity. Each item is rated from 0 to 3. The AISRS total score can range from 0 to 54. A higher score corresponds to a worse severity of ADHD. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Symptoms | The Adult ADHD investigator symptom rating scale (AISRS) total score consists of 18 items from the original Attention-deficit/hyperactivity Disorder Rating Scale (ADHD-RS). The ADHD-RS includes 9 items that address symptoms of inattention, and 9 items that address symptoms of impulsivity and hyperactivity. Each item is rated from 0 to 3. The AISRS total score can range from 0 to 54. A higher score corresponds to a worse severity of ADHD. |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic Outcomes | Maximum Plasma Concentration [Cmax] of MM-120 in the blood at Week 1 Day 1 | 0.5, 1, 2, 3, 4, 6 hours post-dose |
| Pharmacokinetic Parameters (Cmax) | Maximum concentration (Cmax) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kim Kuypers | Maastricht University | Principal Investigator |
| Matthias Liechti | University Hospital, Basel, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University | Maastricht | Netherlands | ||||
| University Hospital Basel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42322409 | Derived | Haijen-Bongers ECHM, Hurks PPM, Schepers J, Vizeli P, Santos de Jesus J, Mueller L, Schmid Y, Liechti ME, Kuypers KPC. Effects of repeated low-dose LSD on neuropsychological functioning in adults with ADHD: a randomized placebo-controlled study. Psychopharmacology (Berl). 2026 Jun 20. doi: 10.1007/s00213-026-07107-7. Online ahead of print. | |
| 40105807 |
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A total of 74 potential participants were screened and 21 were excluded.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 2- MM120 | A total of 26 patients will receive 20 μg of MM120 administered orally twice weekly for 6 weeks. MM120: MM120 is a psychedelic drug that can cause intensified thoughts, emotions, and sensory perception. At sufficiently high dosages MM120 manifests primarily visual, as well as auditory, hallucinations. |
| FG001 | Arm 1- Placebo | A total of 26 patients will receive a placebo identical in appearance to the investigational medicinal product (IMP) administered orally twice weekly (e.g., Tuesday/Friday) for 6 weeks. Placebo: A treatment which is designed to have no therapeutic value. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
A summary of demographic information for the FAS is shown below.
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 2- MM120 | A total of 26 patients will receive 20 μg of MM120 administered orally twice weekly for 6 weeks. MM120: MM120 is a psychedelic drug that can cause intensified thoughts, emotions, and sensory perception. At sufficiently high dosages MM120 manifests primarily visual, as well as auditory, hallucinations. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Symptoms | The Adult ADHD investigator symptom rating scale (AISRS) total score consists of 18 items from the original Attention-deficit/hyperactivity Disorder Rating Scale (ADHD-RS). The ADHD-RS includes 9 items that address symptoms of inattention, and 9 items that address symptoms of impulsivity and hyperactivity. Each item is rated from 0 to 3. The AISRS total score can range from 0 to 54. A higher score corresponds to a worse severity of ADHD. | Full Analysis Set (FAS): All subjects in the randomized set (RAN) who were not mis-randomized | Posted | Mean | Standard Deviation | units on a scale | 6 weeks |
|
From time of signing ICF (or screening visit) through study completion, typically 14 weeks.
Each event was to be described in detail, along with start and stop dates, severity, relationship to IMP, action taken, and outcome. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) as specified in the SAP.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 2- MM120 | A total of 26 patients will receive 20 μg of MM120 administered orally twice weekly for 6 weeks. MM120: MM120 is a psychedelic drug that can cause intensified thoughts, emotions, and sensory perception. At sufficiently high dosages MM120 manifests primarily visual, as well as auditory, hallucinations. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
Although a multicenter-trial, one site enrolled 95% of participants. Only twice-weekly dose regimen was tested, which may not account for interindividual variability in response. Finally, other outcomes such as emotion regulation were not addressed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Affairs | Definium Therapeutics US, Inc. | 1-332-245-4732 | MedAffairs@definiumtx.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 9, 2022 | Nov 27, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 19, 2023 | Nov 27, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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|
| Placebo | Other | A treatment which is designed to have no therapeutic value. |
|
| Week 2 |
| Number of Patients Who Experience a Decrease in the Clinical Global Impressions Scale (CGI-S) | The Clinical Global Impression - Severity (CGI-S) was used to assess the subject's current severity of illness at the time of the assessment relative to the clinician's past experience with patients who have the same diagnosis. The CGI-S comprises 1 Investigator-completed (or trained rater-completed) item with 7 possible ratings (1-7 points), where a higher score indicates more severe illness. | Baseline, Week 2, Week 6, Week 10 |
| Change From Baseline in in Clinical Global Impressions Scale (CGI-S) | The Clinical Global Impression - Severity (CGI-S) was used to assess the subject's current severity of illness at the time of the assessment relative to the clinician's past experience with patients who have the same diagnosis. The CGI-S comprises 1 Investigator-completed (or trained rater-completed) item with 7 possible ratings (1-7 points), where a higher score indicates more severe illness. | Baseline, Week 2, Week 6 |
| Adult Attention-deficit/Hyperactivity Disorder Self-reporting Rating Scale (ASRS) | The Adult Attention-Deficit/Hyperactivity Disorder Self-Reporting Rating Scale (ASRS) is composed of 18 questions, and uses a scale that ranges from 0-4 based on the individuals mark in either the "never, rarely, sometimes, often, very often" column for a possible total score of 72. A higher score corresponds to a worse severity of ADHD. | 6 weeks |
| Change From Baseline in Connors' Adult ADHD Rating Scale (CAARS) | The Connors' Adult ADHD Rating Scale (CAARS) Self-Report Long Form is a 66-item measure of ADHD symptom. Responses are scored on a 4-point scale, where 0 = not at all, 1 = just a little, 2 = pretty much, and 3 = very much. Item scores are summed to three main scores which are then transformed using population-derived age- and sex-adjusted norm values to a T-score. A T-score < 60 indicates no ADHD. A T-score of 60-64 indicates borderline ADHD. A T-score of > 64 indicates ADHD. | 6 weeks |
| 5 Dimensions of Altered States of Consciousness Questionnaire (5D-ASC) Scores | The 5 dimensions of altered states of consciousness (5D-ASC) scale is a visual analog scale (VAS) consisting of 94 items each scored on a 0-100mm VAS extrapolated to 100% scale for quantitative evaluation. These 94 items are categorized into five dimensions: oceanic boundlessness (min:0, max:2700), anxious ego dissolution (min:0, max:2100), visionary destructuralization (min:0, max:1800), auditory alterations (min:0, max:1600), and vigilance reduction (min:0, max:1200). The total score is the sum of all questions and can range from 0 to 9400. Higher scores = more alteration in state of consciousness. | 6 weeks |
| Mystical Experience Questionnaire 30 Items (MEQ30) | The Mystical Experience Questionnaire 30 item (MEQ30) is a 30-item questionnaire rated on a six-point scale. The scale has been used to assess mystical experiences in studies using psilocybin and LSD. Higher scores = greater mystical experiences. The total score is expressed as a percentage of the maximum possible score (0 to 100%). | 6 weeks |
| Summary of Drug Effects Visual Analog Scale (VAS) | A series of single item visual Analog Scales (VAS) are used repeatedly 0 -6 hours after drug administration: The following 9 items were used in VAS (0-100 mm): "any drug effect", "good drug effect", bad drug effect", "drug liking", "fear", nausea", "alteration of vision", "alteration of sense of time", and "the boundaries between myself and my surroundings seem to blur". VAS scores range from 0 = no effect to 100 = strong effect. The scores for each item are extrapolated to a 100% scale and presented for each time point of assessment. | 6 hours |
| 0.5, 1, 2, 3, 4, 6 hours post-dose |
| Pharmacokinetic Parameters (Tmax and t1/2) | Time to maximum concentration (Tmax), half life (t1/2) | 0.5, 1, 2, 3, 4, 6 hours post-dose |
| Pharmacokinetic Parameters (AUC0-inf and AUC0-6h) | Area under the concentration curve from time 0 to infinity (AUC0-inf), Area under the concentration curve from time 0 to 6 hour (AUC0-6h) | 0.5, 1, 2, 3, 4, 6 hours post-dose |
| Basel |
| Switzerland |
| Mueller L, Santos de Jesus J, Schmid Y, Muller F, Becker A, Klaiber A, Straumann I, Luethi D, Haijen ECHM, Hurks PPM, Kuypers KPC, Liechti ME. Safety and Efficacy of Repeated Low-Dose LSD for ADHD Treatment in Adults: A Randomized Clinical Trial. JAMA Psychiatry. 2025 Jun 1;82(6):555-562. doi: 10.1001/jamapsychiatry.2025.0044. |
| Pregnancy |
|
| Arm 1- Placebo |
A total of 26 patients will receive a placebo identical in appearance to the investigational medicinal product (IMP) administered orally twice weekly (e.g., Tuesday/Friday) for 6 weeks. Placebo: A treatment which is designed to have no therapeutic value. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Baseline ADHD investigator symptom rating scale (AISRS) | The Adult ADHD investigator symptom rating scale (AISRS) total score consists of 18 items from the original Attention-deficit/hyperactivity Disorder Rating Scale (ADHD-RS). The ADHD-RS includes 9 items that address symptoms of inattention, and 9 items that address symptoms of impulsivity and hyperactivity. Each item is rated from 0 to 3. The AISRS total score can range from 0 to 54. A higher score corresponds to a worse severity of ADHD. | Baseline values from subjects not included in Primary efficacy analysis were excluded from this calculation | Mean | Standard Deviation | units on a scale |
|
| OG001 | Arm 1- Placebo | A total of 26 patients will receive a placebo identical in appearance to the investigational medicinal product (IMP) administered orally twice weekly (e.g., Tuesday/Friday) for 6 weeks. Placebo: A treatment which is designed to have no therapeutic value. |
|
|
|
| Secondary | Changes in Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Symptoms | The Adult ADHD investigator symptom rating scale (AISRS) total score consists of 18 items from the original Attention-deficit/hyperactivity Disorder Rating Scale (ADHD-RS). The ADHD-RS includes 9 items that address symptoms of inattention, and 9 items that address symptoms of impulsivity and hyperactivity. Each item is rated from 0 to 3. The AISRS total score can range from 0 to 54. A higher score corresponds to a worse severity of ADHD. | Full Analysis Set (FAS): All subjects in the randomized set (RAN) who were not mis-randomized | Posted | Mean | Standard Deviation | units on a scale | Week 2 |
|
|
|
|
| Secondary | Number of Patients Who Experience a Decrease in the Clinical Global Impressions Scale (CGI-S) | The Clinical Global Impression - Severity (CGI-S) was used to assess the subject's current severity of illness at the time of the assessment relative to the clinician's past experience with patients who have the same diagnosis. The CGI-S comprises 1 Investigator-completed (or trained rater-completed) item with 7 possible ratings (1-7 points), where a higher score indicates more severe illness. | Full Analysis Set (FAS): All subjects in the randomized set (RAN) who were not mis-randomized | Posted | Count of Participants | Participants | Baseline, Week 2, Week 6, Week 10 |
|
|
|
| Secondary | Change From Baseline in in Clinical Global Impressions Scale (CGI-S) | The Clinical Global Impression - Severity (CGI-S) was used to assess the subject's current severity of illness at the time of the assessment relative to the clinician's past experience with patients who have the same diagnosis. The CGI-S comprises 1 Investigator-completed (or trained rater-completed) item with 7 possible ratings (1-7 points), where a higher score indicates more severe illness. | Full Analysis Set (FAS): All subjects in the randomized set (RAN) who were not mis-randomized | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 2, Week 6 |
|
|
|
| Secondary | Adult Attention-deficit/Hyperactivity Disorder Self-reporting Rating Scale (ASRS) | The Adult Attention-Deficit/Hyperactivity Disorder Self-Reporting Rating Scale (ASRS) is composed of 18 questions, and uses a scale that ranges from 0-4 based on the individuals mark in either the "never, rarely, sometimes, often, very often" column for a possible total score of 72. A higher score corresponds to a worse severity of ADHD. | Full Analysis Set (FAS): All subjects in the randomized set (RAN) who were not mis-randomized | Posted | Mean | Standard Deviation | units on a scale | 6 weeks |
|
|
|
| Secondary | Change From Baseline in Connors' Adult ADHD Rating Scale (CAARS) | The Connors' Adult ADHD Rating Scale (CAARS) Self-Report Long Form is a 66-item measure of ADHD symptom. Responses are scored on a 4-point scale, where 0 = not at all, 1 = just a little, 2 = pretty much, and 3 = very much. Item scores are summed to three main scores which are then transformed using population-derived age- and sex-adjusted norm values to a T-score. A T-score < 60 indicates no ADHD. A T-score of 60-64 indicates borderline ADHD. A T-score of > 64 indicates ADHD. | Full Analysis Set (FAS): All subjects in the randomized set (RAN) who were not mis-randomized | Posted | Mean | Standard Deviation | units on a scale | 6 weeks |
|
|
|
| Secondary | 5 Dimensions of Altered States of Consciousness Questionnaire (5D-ASC) Scores | The 5 dimensions of altered states of consciousness (5D-ASC) scale is a visual analog scale (VAS) consisting of 94 items each scored on a 0-100mm VAS extrapolated to 100% scale for quantitative evaluation. These 94 items are categorized into five dimensions: oceanic boundlessness (min:0, max:2700), anxious ego dissolution (min:0, max:2100), visionary destructuralization (min:0, max:1800), auditory alterations (min:0, max:1600), and vigilance reduction (min:0, max:1200). The total score is the sum of all questions and can range from 0 to 9400. Higher scores = more alteration in state of consciousness. | Full Analysis Set (FAS): All subjects in the randomized set (RAN) who were not mis-randomized. | Posted | Mean | 95% Confidence Interval | units on a scale | 6 weeks |
|
|
|
| Secondary | Mystical Experience Questionnaire 30 Items (MEQ30) | The Mystical Experience Questionnaire 30 item (MEQ30) is a 30-item questionnaire rated on a six-point scale. The scale has been used to assess mystical experiences in studies using psilocybin and LSD. Higher scores = greater mystical experiences. The total score is expressed as a percentage of the maximum possible score (0 to 100%). | Full Analysis Set (FAS): All subjects in the randomized set (RAN) who were not mis-randomized. | Posted | Mean | 95% Confidence Interval | percentage of maximum possible score | 6 weeks |
|
|
|
| Secondary | Summary of Drug Effects Visual Analog Scale (VAS) | A series of single item visual Analog Scales (VAS) are used repeatedly 0 -6 hours after drug administration: The following 9 items were used in VAS (0-100 mm): "any drug effect", "good drug effect", bad drug effect", "drug liking", "fear", nausea", "alteration of vision", "alteration of sense of time", and "the boundaries between myself and my surroundings seem to blur". VAS scores range from 0 = no effect to 100 = strong effect. The scores for each item are extrapolated to a 100% scale and presented for each time point of assessment. | Full Analysis Set (FAS): All subjects in the randomized set (RAN) who were not mis-randomized. | Posted | Mean | Full Range | percentage of maximum possible score | 6 hours |
|
|
|
| Other Pre-specified | Pharmacokinetic Outcomes | Maximum Plasma Concentration [Cmax] of MM-120 in the blood at Week 1 Day 1 | Pharmacokinetic Set (PKS): All subjects in the randomized set (RAN) who received a dose of MM120 and had at least 1 postdose PK measurement without important protocol deviations thought to significantly affect the PK of the drug. A strategy for dealing with data affected by protocol violations and deviations was to be agreed to by the Sponsor, monitor, and pharmacokineticist, prior to clean file and code break. Subjects were analyzed according to the treatment they actually received. | Posted | Mean | Standard Deviation | ng/mL | 0.5, 1, 2, 3, 4, 6 hours post-dose |
|
|
|
| Other Pre-specified | Pharmacokinetic Parameters (Cmax) | Maximum concentration (Cmax) | Pharmacokinetic Set (PKS): All subjects in the randomized set (RAN) who received a dose of MM120 and had at least 1 postdose PK measurement without important protocol deviations thought to significantly affect the PK of the drug. A strategy for dealing with data affected by protocol violations and deviations was to be agreed to by the Sponsor, monitor, and pharmacokineticist, prior to clean file and code break. Subjects were analyzed according to the treatment they actually received. | Posted | Mean | Standard Deviation | ng/mL | 0.5, 1, 2, 3, 4, 6 hours post-dose |
|
|
|
| Other Pre-specified | Pharmacokinetic Parameters (Tmax and t1/2) | Time to maximum concentration (Tmax), half life (t1/2) | Pharmacokinetic Set (PKS): All subjects in the randomized set (RAN) who received a dose of MM120 and had at least 1 postdose PK measurement without important protocol deviations thought to significantly affect the PK of the drug. A strategy for dealing with data affected by protocol violations and deviations was to be agreed to by the Sponsor, monitor, and pharmacokineticist, prior to clean file and code break. Subjects were analyzed according to the treatment they actually received. | Posted | Mean | Standard Deviation | hours | 0.5, 1, 2, 3, 4, 6 hours post-dose |
|
|
|
| Other Pre-specified | Pharmacokinetic Parameters (AUC0-inf and AUC0-6h) | Area under the concentration curve from time 0 to infinity (AUC0-inf), Area under the concentration curve from time 0 to 6 hour (AUC0-6h) | Pharmacokinetic Set (PKS): All subjects in the randomized set (RAN) who received a dose of MM120 and had at least 1 postdose PK measurement without important protocol deviations thought to significantly affect the PK of the drug. A strategy for dealing with data affected by protocol violations and deviations was to be agreed to by the Sponsor, monitor, and pharmacokineticist, prior to clean file and code break. Subjects were analyzed according to the treatment they actually received. | Posted | Mean | Standard Deviation | ng*h/mL | 0.5, 1, 2, 3, 4, 6 hours post-dose |
|
|
|
| 0 |
| 27 |
| 0 |
| 27 |
| 21 |
| 27 |
| EG001 | Arm 1- Placebo | A total of 26 patients will receive a placebo identical in appearance to the investigational medicinal product (IMP) administered orally twice weekly (e.g., Tuesday/Friday) for 6 weeks. Placebo: A treatment which is designed to have no therapeutic value. | 0 | 26 | 0 | 26 | 23 | 26 |
| Disturbance in Attention | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Akathisia | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Restless leg syndrome | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Illusion | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
|
| Apathy | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
|
| Euphoric mood | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
|
| Flashbacks | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
|
| Hypersomnia | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Feeling abnormal | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Swelling | General disorders | MedDRA 25.1 | Systematic Assessment |
|
| Full blood count abnormal | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Heart rate increased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Pregnancy test positive | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| SARS-CoV-2 test positive | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Urine cannabinoids increased | Investigations | MedDRA 25.1 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
|
| Palate injury | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
|
| Syncope | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Throat tightness | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA 25.1 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 25.1 | Systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA 25.1 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
|
| Urethritis noninfective | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
|
| Premenstrual pain | Reproductive system and breast disorders | MedDRA 25.1 | Systematic Assessment |
|
| High risk sexual behaviour | Social circumstances | MedDRA 25.1 | Systematic Assessment |
|
| Tooth extraction | Surgical and medical procedures | MedDRA 25.1 | Systematic Assessment |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Baseline to Week 10 |
|
| Week 2 |
|
|
| Baseline for Week 6 |
|
|
| Week 6 |
|
|
| Week 2 |
|
|
| Baseline for Week 4 |
|
|
| Week 4 |
|
|
| Baseline for Week 6 (Day 36) |
|
|
| Week 6 (Day 36) |
|
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| Baseline to Week 6 (Day 40) |
|
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| Week 6 (Day 40) |
|
|
| Change from baseline to Week 4 |
|
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| Change from Baseline to Week 6 (Day 36) |
|
|
| Change from Baseline to Week 6 (Day 40) |
|
|
| W1D1 Anxious ego dissolution |
|
|
| W1D1 Visionary destructuralization |
|
|
| W1D1 Auditory alterations |
|
|
| W1D1 Vigilance reduction |
|
|
| W1D1 Total score |
|
|
| W6 Oceanic boundlessness |
|
|
| W6 Anxious ego dissolution |
|
|
| W6 Visionary destructuralization |
|
|
| W6 Auditory alterations |
|
|
| W6 Vigilance reduction |
|
|
| W6 Total scores |
|
|
| Week 6 |
|
|
| 0h Fear |
|
| 0h Nausea |
|
| 0h Alteration of vision |
|
| 0h Alteration of sense of time |
|
| 0h Boundaries blur |
|
| 0.5h Any drug effect |
|
| 0.5h Drug liking |
|
| 0.5h Fear |
|
| 0.5h Nausea |
|
| 0.5h Alteration of vision |
|
| 0.5h Alteration of sense of time |
|
| 0.5h Boundaries blur |
|
| 1h Any drug effect |
|
| 1h Drug liking |
|
| 1h Fear |
|
| 1h Nausea |
|
| 1h Alteration of vision |
|
| 1h Alteration of sense of time |
|
| 1h Boundaries blur |
|
| 2h Any drug effect |
|
| 2h Drug liking |
|
| 2h Fear |
|
| 2h Nausea |
|
| 2h Alteration of vision |
|
| 2h Alteration of sense of time |
|
| 2h Boundaries blur |
|
| 3h Any drug effect |
|
| 3h Drug liking |
|
| 3h Fear |
|
| 3h Nausea |
|
| 3h Alteration of vision |
|
| 3h Alteration of sense of time |
|
| 3h Boundaries blur |
|
| 4h Any drug effect |
|
| 4h Drug liking |
|
| 4h Fear |
|
| 4h Nausea |
|
| 4h Alteration of vision |
|
| 4h Alteration of sense of time |
|
| 4h Boundaries blur |
|
| 6h Any drug effect |
|
| 6h Drug liking |
|
| 6h Fear |
|
| 6h Nausea |
|
| 6h Alteration of vision |
|
| 6h Alteration of sense of time |
|
| 6h Boundaries blur |
|
| Title | Measurements |
|---|---|
|
| 2hours |
|
| 3hours |
|
| 4hours |
|
| 6hours |
|