Diabetes Mellitus
Conditions
Brief summary
The present study is a phase 1 dose escalation study of harmine in healthy volunteers. The primary goal of the trial is to determine the maximum tolerated dose of harmine.
Detailed description
The present study is a phase 1 dose escalation study of harmine in healthy volunteers. The primary goal of the trial is to determine the maximum tolerated dose of harmine. Harmine will be administered in an open-label, dose escalation design that will use the continual reassessment method to inform the next dose to test in a subject. There will be a total of seven possible doses that include 100 mg, 200 mg, 300 mg, 500 mg, 700 mg, 900 mg and 1200 mg. Each study subject will receive a single oral dose of harmine in this single ascending dose design. On the treatment day, subjects will undergo continuous medical monitoring. All adverse events will be documented and events that qualify as dose limiting toxicities (DLTs) will be used to inform dosing for the subsequent subjects.
Interventions
DRUGHarmine Hydrochloride Capsules
capsules taken orally
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
James Murrough
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study will employ the continual reassessment method (CRM) to find an MTD of Harmine. It uses a statistical model to estimate the relationship between dose and DLT risk to inform decisions on dosing. It first starts with a selected target DLT rate and a mathematical model for the relationship between dose and toxicity, the prior dose-toxicity curve. After a patient experiences a DLT or not, the dose-toxicity curve is re-fit incorporating the latest outcome. The next dose assigned is that most likely to be associated with the target toxicity level (the MTD). At every step, the next patient is assigned the dose estimated to be nearest to the MTD.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female aged 18-55 years; * Participants must have a level of understanding of the English language sufficient to agree to all tests and examinations required by the study and must be able to participate fully in the informed consent process; * Body Mass Index (BMI) between 19 and 30; * Women of childbearing potential and men must be using an acceptable method of contraception to avoid pregnancy throughout the study as judged by the investigator; * Women must not be breastfeeding;
Exclusion criteria
* Children under the age of 18 and adults over the age of 55 due to concerns regarding neurodevelopmental and neurocognitive effects, respectively. * Individuals who are underweight as defined as a BMI \<19, or who are obese as defined as \>30 according to the Centers for Disease Control (CDC). These criteria are in line with the goals of a phase I dose finding and pharmacokinetic study. * Presence of a significant medical illness i.e., delirium, metastatic cancer, decompensated cardiac, liver or kidney failure, major surgery, stroke or myocardial infarction during the three months prior to entry; * Presence of a significant neurological disease such as Parkinson's disease, primary or secondary seizure disorders, intracranial tumors, severe head trauma; neurodegenerative diseases; * Presence of neurocognitive or dementing disorders; * Presence or history of psychiatric disorder as diagnosed by Mini Neuropsychiatric Interview (MINI); * Urine toxicology positive for illicit drugs or dis-allowed concomitant medications as per study protocol; * Medications with primary central nervous system (CNS) effects are dis-allowed, including psychotropic medications, antidepressants, benzodiazepines, centrally acting hypnotic agents, and centrally acting anti-migraine therapies; * Medications with primary cardiovascular effects are dis-allowed, including beta-adrenergic antagonists, ACE inhibitors, calcium channel blockers, and diuretics; * Any OTC medications or herbal remedies (see concomitant medications listed above) that could interfere with the study drug, pose a risk to the subject, or contain high tyramine as outlined in the Low Tyramine Diet attachment and above in the concomitant medication summary; * Any other medications that, in the opinion of the investigators, would pose a safety risk to the patient or that would interfere with the interpretation of study results; Positive pregnancy test at screen or on the morning of the treatment day in women of childbearing potential; * Systolic blood pressure outside the range of 100 - 140 mmHg, diastolic blood pressure outside the range of 60 - 90 mmHg, and pulse rate at rest \> 100 or \< 60 bpm; * History of positive tests for hepatitis B surface antigen, hepatitis C antibodies; * History of HIV; * Significant ECG abnormalities as follows: * Heart Rate \< 60 and \>100 bpm * PR Interval \<120 and \> 220 ms * QRS duration \< 70 and \>120 ms * QTC Interval (Bazett) \> 450 ms
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Dose Limiting Toxicity (DLT) | 24 hours | DLT which is defined if have any one of the following: Patient Rated Inventory of Side Effects (PRISE): 0-51, higher scores indicate more adverse events observed Brief Psychiatric Rating Scale (BPRS): 4 - 28, higher scores indicate more symptoms of psychosis Vitals: blood pressure and heart rate will all be measured - anything outside of the following ranges will be noted: * Symptomatic hypotension, or \> 20% decrease in systolic blood pressure (SBP) from pre-dosing and an absolute SBP \< 90; or * Symptomatic hypertension, or \> 20% increase in SBP or diastolic blood pressure (DBP) from predosing and absolute SBP \> 170 or DBP \> 95; * New onset tachycardia (heart rate \>100 bpm) and \>20% increase from pre-dosing; or symptomatic bradycardia (heart rate \<60 bpm) and \> 20% decrease from pre-dosing. * Signs and symptoms of cardiac ischemia, defined by acute ischemic changes on ECG with or without concomitant symptoms |
| Maximum Tolerated Dose (MTD) of Oral Harmine HCl Based on Dose Limiting Toxicity (DLT) | 24 hours | The MTD was determined to be between 100 and 200mg and is weight-based. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) - Feeling High/Intoxicated | baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7 8, and 24 hours | Visual Analog Scale (VAS) to characterize psychoactive effects of harmine in healthy adults. Full scale from 0-10, with higher scores indicating subjective states are experienced more strongly |
| Visual Analog Scale (VAS) - Drowsiness | baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7 8, and 24 hours | Visual Analog Scale (VAS) to characterize psychoactive effects of harmine in healthy adults. Full scale from 0-10, with higher scores indicating subjective states are experienced more strongly |
| Visual Analog Scale (VAS) - Anxiety | baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7 8, and 24 hours | Visual Analog Scale (VAS) to characterize psychoactive effects of harmine in healthy adults. Full scale from 0-10, with higher scores indicating subjective states are experienced more strongly |
| Visual Analog Scale (VAS) - Depressed Mood | baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7 8, and 24 hours | Visual Analog Scale (VAS) to characterize psychoactive effects of harmine in healthy adults. Full scale from 0-10, with higher scores indicating subjective states are experienced more strongly. |
| Visual Analog Scale (VAS) - Happy Mood | baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7 8, and 24 hours | Visual Analog Scale (VAS) to characterize psychoactive effects of harmine in healthy adults. Full scale from 0-10, with higher scores indicating subjective states are experienced more strongly |
| Visual Analog Scale (VAS) - Excitement | baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7 8, and 24 hours | Visual Analog Scale (VAS) to characterize psychoactive effects of harmine in healthy adults. Full scale from 0-10, with higher scores indicating subjective states are experienced more strongly. |
| Visual Analog Scale (VAS) - Feeling of Control | baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7 8, and 24 hours | Visual Analog Scale (VAS) to characterize psychoactive effects of harmine in healthy adults. Full scale from 0-10, with higher scores indicating subjective states are experienced more strongly. |
| Visual Analog Scale (VAS) - Vividness of Image | baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7 8, and 24 hours | Visual Analog Scale (VAS) to characterize psychoactive effects of harmine in healthy adults. Full scale from 0-10, with higher scores indicating subjective states are experienced more strongly. |
| Profile of Mood States Bipolar Scale (POMS-Bi): Composed-Anxious Scale | Baseline, 2, 6, 7, 8, and 24 hours | The POMS-Bi is a 72-item psychological self-report rating scale used to assess transient, distinct mood states. It is also a validated instrument for identifying the effects of drug treatments. Items are rated on a four-point scale from 0 much unlike this to 3 much like this. It includes six bipolar scales: composed-anxious, agreeable-hostile, elated-depressed, confident-unsure, energetic-tired, and clearheaded-confused. Each subscale is scored 0-36, with higher scores associated with better mood |
| Visual Analog Scale (VAS) - Nausea | baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7 8, and 24 hours | Visual Analog Scale (VAS) to characterize psychoactive effects of harmine in healthy adults. Full scale from 0-10, with higher scores indicating subjective states are experienced more strongly |
| Profile of Mood States Bipolar Scale (POMS-Bi): Elated-Depression Scale | Baseline, 2, 6, 7, 8, and 24 hours | The POMS-Bi is a 72-item psychological self-report rating scale used to assess transient, distinct mood states. It is also a validated instrument for identifying the effects of drug treatments. Items are rated on a four-point scale from 0 much unlike this to 3 much like this. It includes six bipolar scales: composed-anxious, agreeable-hostile, elated-depressed, confident-unsure, energetic-tired, and clearheaded-confused. Each subscale is scored 0-36, with higher scores associated with better mood |
| Profile of Mood States Bipolar Scale (POMS-Bi): Confident-Unsure Scale | Baseline, 2, 6, 7, 8, and 24 hours | The POMS-Bi is a 72-item psychological self-report rating scale used to assess transient, distinct mood states. It is also a validated instrument for identifying the effects of drug treatments. Items are rated on a four-point scale from 0 much unlike this to 3 much like this. It includes six bipolar scales: composed-anxious, agreeable-hostile, elated-depressed, confident-unsure, energetic-tired, and clearheaded-confused. Each subscale is scored 0-36, with higher scores associated with better mood |
| Profile of Mood States Bipolar Scale (POMS-Bi): Energetic-Tired Scale | Baseline, 2, 6, 7, 8, and 24 hours | The POMS-Bi is a 72-item psychological self-report rating scale used to assess transient, distinct mood states. It is also a validated instrument for identifying the effects of drug treatments. Items are rated on a four-point scale from 0 much unlike this to 3 much like this. It includes six bipolar scales: composed-anxious, agreeable-hostile, elated-depressed, confident-unsure, energetic-tired, and clearheaded-confused. Each subscale is scored 0-36, with higher scores associated with better mood |
| Profile of Mood States Bipolar Scale (POMS-Bi): Clearheaded-Confused Scale | Baseline, 2, 6, 7, 8, and 24 hours | The POMS-Bi is a 72-item psychological self-report rating scale used to assess transient, distinct mood states. It is also a validated instrument for identifying the effects of drug treatments. Items are rated on a four-point scale from 0 much unlike this to 3 much like this. It includes six bipolar scales: composed-anxious, agreeable-hostile, elated-depressed, confident-unsure, energetic-tired, and clearheaded-confused. Each subscale is scored 0-36, with higher scores associated with better mood |
| Perceived Stress Scale (PSS) | 24 hours | The PSS is a 10-item self-report scale that measures the perception of stress. Each item is rated on a scale from 0-4. Full scale from 0-40, with higher score indicating more perceived stress |
| Patient Rated Inventory of Side Effects (PRISE) | 24 hours | The PRISE is a self-report Adverse Event (AE) Checklist used to qualify side effects by identifying and evaluating the tolerability of each symptom. Only new onset or worsening symptoms were included. Participants could report more than one AE. |
| Brief Psychiatric Rating Scale (BPRS) | Baseline, 2, 6, 7, 8, and 24 hours | The BPRS is a 16-item clinician- administered scale that captures acute behavioral changes throughout treatment. Each item is rated on a scale from 1-7. Full scale from 16-112 with higher score indicating more worse health outcomes. |
| Columbia Suicide Severity Rating Scale (C-SSRS) | 24 hours | The C-SSRS is a clinician-administered suicidal ideation and behavior rating scale used to evaluate suicide risk. Full range from 0 (low intensity suicidal ideation to 9 (high intensity suicidal ideation). |
| Profile of Mood States Bipolar Scale (POMS-Bi): Agreeable-Hostile Scale | Baseline, 2, 6, 7, 8, and 24 hours | The POMS-Bi is a 72-item psychological self-report rating scale used to assess transient, distinct mood states. It is also a validated instrument for identifying the effects of drug treatments. Items are rated on a four-point scale from 0 much unlike this to 3 much like this. It includes six bipolar scales: composed-anxious, agreeable-hostile, elated-depressed, confident-unsure, energetic-tired, and clearheaded-confused. Each subscale is scored 0-36, with higher scores associated with better mood |
| Visual Analog Scale (VAS) - Hunger | baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7 8, and 24 hours | Visual Analog Scale (VAS) to characterize psychoactive effects of harmine in healthy adults. Full scale from 0-10, with higher scores indicating subjective states are experienced more strongly. |
Countries
United States
Participant flow
Recruitment details
Between September 2022, and June 2023, a total of 34 participants signed consent with 7 failed screening. 27 were enrolled
Participants by arm
| Arm | Count |
|---|---|
| Harmine Dose 100 mg Each study subject received a single oral dose of harmine in this single ascending dose design.
Harmine Hydrochloride Capsules: capsules taken orally | 10 |
| Harmine 200 mg Each study subject received a single oral dose of harmine in this single ascending dose design.
Harmine Hydrochloride Capsules: capsules taken orally | 10 |
| Harmine >200mg Each study subject received a single oral dose of harmine in this single ascending dose design.
Harmine Hydrochloride Capsules: capsules taken orally | 5 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 2 | 0 | 0 |
Baseline characteristics
| Characteristic | Harmine >200mg | Total | Harmine 200 mg | Harmine Dose 100 mg |
|---|---|---|---|---|
| Age, Continuous | 29.4 years STANDARD_DEVIATION 3.9 | 29.9 years STANDARD_DEVIATION 6.3 | 31.1 years STANDARD_DEVIATION 7.3 | 28.9 years STANDARD_DEVIATION 6.6 |
| Body mass index | 25.2 kg/m^2 STANDARD_DEVIATION 4 | 24.8 kg/m^2 STANDARD_DEVIATION 3 | 24.5 kg/m^2 STANDARD_DEVIATION 3 | 24.8 kg/m^2 STANDARD_DEVIATION 2.7 |
| Education level Completed graduate/professional school | 0 Participants | 9 Participants | 5 Participants | 4 Participants |
| Education level Graduated 2-year college/trade school | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Education level Graduated 4-year college | 2 Participants | 4 Participants | 0 Participants | 2 Participants |
| Education level Some college | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Education level Some graduate/professional school | 3 Participants | 10 Participants | 4 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 6 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 18 Participants | 8 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Marital status Married/living with someone as if married | 1 Participants | 9 Participants | 4 Participants | 4 Participants |
| Marital status Never married | 4 Participants | 16 Participants | 6 Participants | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 7 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 12 Participants | 5 Participants | 4 Participants |
| Sex: Female, Male Female | 2 Participants | 12 Participants | 5 Participants | 5 Participants |
| Sex: Female, Male Male | 3 Participants | 13 Participants | 5 Participants | 5 Participants |
| Weight | 76 kg STANDARD_DEVIATION 22.6 | 69.6 kg STANDARD_DEVIATION 15 | 69.7 kg STANDARD_DEVIATION 14.9 | 66.2 kg STANDARD_DEVIATION 10.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 | 0 / 5 |
| other Total, other adverse events | 2 / 10 | 5 / 10 | 5 / 5 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 5 |
Outcome results
Primary
Maximum Tolerated Dose (MTD) of Oral Harmine HCl Based on Dose Limiting Toxicity (DLT)
The MTD was determined to be between 100 and 200mg and is weight-based.
Time frame: 24 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Harmine Hydrochloride 100mg | Maximum Tolerated Dose (MTD) of Oral Harmine HCl Based on Dose Limiting Toxicity (DLT) | 2.7 mg/kg |
Primary
Number of Participants With Dose Limiting Toxicity (DLT)
DLT which is defined if have any one of the following: Patient Rated Inventory of Side Effects (PRISE): 0-51, higher scores indicate more adverse events observed Brief Psychiatric Rating Scale (BPRS): 4 - 28, higher scores indicate more symptoms of psychosis Vitals: blood pressure and heart rate will all be measured - anything outside of the following ranges will be noted: * Symptomatic hypotension, or \> 20% decrease in systolic blood pressure (SBP) from pre-dosing and an absolute SBP \< 90; or * Symptomatic hypertension, or \> 20% increase in SBP or diastolic blood pressure (DBP) from predosing and absolute SBP \> 170 or DBP \> 95; * New onset tachycardia (heart rate \>100 bpm) and \>20% increase from pre-dosing; or symptomatic bradycardia (heart rate \<60 bpm) and \> 20% decrease from pre-dosing. * Signs and symptoms of cardiac ischemia, defined by acute ischemic changes on ECG with or without concomitant symptoms
Time frame: 24 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Harmine Hydrochloride 100mg | Number of Participants With Dose Limiting Toxicity (DLT) | 0 Participants |
| Harmine Hydrochloride 200mg | Number of Participants With Dose Limiting Toxicity (DLT) | 6 Participants |
| Harmine Hydrochloride 300mg | Number of Participants With Dose Limiting Toxicity (DLT) | 4 Participants |
| Harmine Hydrochloride 500mg | Number of Participants With Dose Limiting Toxicity (DLT) | 1 Participants |
Secondary
Brief Psychiatric Rating Scale (BPRS)
The BPRS is a 16-item clinician- administered scale that captures acute behavioral changes throughout treatment. Each item is rated on a scale from 1-7. Full scale from 16-112 with higher score indicating more worse health outcomes.
Time frame: Baseline, 2, 6, 7, 8, and 24 hours
Population: 300mg and 500mg arm combined
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Harmine Hydrochloride 100mg | Brief Psychiatric Rating Scale (BPRS) | 24 hours | 16 score on a scale |
| Harmine Hydrochloride 100mg | Brief Psychiatric Rating Scale (BPRS) | 2 hours | 16 score on a scale |
| Harmine Hydrochloride 100mg | Brief Psychiatric Rating Scale (BPRS) | 6 hours | 16 score on a scale |
| Harmine Hydrochloride 100mg | Brief Psychiatric Rating Scale (BPRS) | 7 hours | 16 score on a scale |
| Harmine Hydrochloride 100mg | Brief Psychiatric Rating Scale (BPRS) | 8 hours | 16 score on a scale |
| Harmine Hydrochloride 100mg | Brief Psychiatric Rating Scale (BPRS) | Baseline | 16 score on a scale |
| Harmine Hydrochloride 200mg | Brief Psychiatric Rating Scale (BPRS) | 7 hours | 16 score on a scale |
| Harmine Hydrochloride 200mg | Brief Psychiatric Rating Scale (BPRS) | Baseline | 16.1 score on a scale |
| Harmine Hydrochloride 200mg | Brief Psychiatric Rating Scale (BPRS) | 6 hours | 16 score on a scale |
| Harmine Hydrochloride 200mg | Brief Psychiatric Rating Scale (BPRS) | 8 hours | 16 score on a scale |
| Harmine Hydrochloride 200mg | Brief Psychiatric Rating Scale (BPRS) | 2 hours | 16.3 score on a scale |
| Harmine Hydrochloride 200mg | Brief Psychiatric Rating Scale (BPRS) | 24 hours | 16 score on a scale |
| Harmine Hydrochloride 300mg | Brief Psychiatric Rating Scale (BPRS) | 2 hours | 16 score on a scale |
| Harmine Hydrochloride 300mg | Brief Psychiatric Rating Scale (BPRS) | 6 hours | 16 score on a scale |
| Harmine Hydrochloride 300mg | Brief Psychiatric Rating Scale (BPRS) | 24 hours | 16 score on a scale |
| Harmine Hydrochloride 300mg | Brief Psychiatric Rating Scale (BPRS) | 7 hours | 16 score on a scale |
| Harmine Hydrochloride 300mg | Brief Psychiatric Rating Scale (BPRS) | 8 hours | 16 score on a scale |
| Harmine Hydrochloride 300mg | Brief Psychiatric Rating Scale (BPRS) | Baseline | 16 score on a scale |
Secondary
Columbia Suicide Severity Rating Scale (C-SSRS)
The C-SSRS is a clinician-administered suicidal ideation and behavior rating scale used to evaluate suicide risk. Full range from 0 (low intensity suicidal ideation to 9 (high intensity suicidal ideation).
Time frame: 24 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Harmine Hydrochloride 100mg | Columbia Suicide Severity Rating Scale (C-SSRS) | 0 score on a scale |
| Harmine Hydrochloride 200mg | Columbia Suicide Severity Rating Scale (C-SSRS) | 0 score on a scale |
| Harmine Hydrochloride 300mg | Columbia Suicide Severity Rating Scale (C-SSRS) | 0 score on a scale |
Secondary
Patient Rated Inventory of Side Effects (PRISE)
The PRISE is a self-report Adverse Event (AE) Checklist used to qualify side effects by identifying and evaluating the tolerability of each symptom. Only new onset or worsening symptoms were included. Participants could report more than one AE.
Time frame: 24 hours
Population: Participants given 300mg and 500mg were combined into one arm
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Harmine Hydrochloride 100mg | Patient Rated Inventory of Side Effects (PRISE) | Blurred vision | 0 Participants |
| Harmine Hydrochloride 100mg | Patient Rated Inventory of Side Effects (PRISE) | Poor coordination | 1 Participants |
| Harmine Hydrochloride 100mg | Patient Rated Inventory of Side Effects (PRISE) | Decreased energy | 3 Participants |
| Harmine Hydrochloride 100mg | Patient Rated Inventory of Side Effects (PRISE) | Tremors | 0 Participants |
| Harmine Hydrochloride 100mg | Patient Rated Inventory of Side Effects (PRISE) | Anxiety | 1 Participants |
| Harmine Hydrochloride 100mg | Patient Rated Inventory of Side Effects (PRISE) | Nausea/vomiting | 0 Participants |
| Harmine Hydrochloride 100mg | Patient Rated Inventory of Side Effects (PRISE) | Sleeping too much | 0 Participants |
| Harmine Hydrochloride 100mg | Patient Rated Inventory of Side Effects (PRISE) | Restlessness | 2 Participants |
| Harmine Hydrochloride 100mg | Patient Rated Inventory of Side Effects (PRISE) | Constipation | 1 Participants |
| Harmine Hydrochloride 100mg | Patient Rated Inventory of Side Effects (PRISE) | Dry mouth | 2 Participants |
| Harmine Hydrochloride 100mg | Patient Rated Inventory of Side Effects (PRISE) | Palpitations | 1 Participants |
| Harmine Hydrochloride 100mg | Patient Rated Inventory of Side Effects (PRISE) | General malaise | 0 Participants |
| Harmine Hydrochloride 100mg | Patient Rated Inventory of Side Effects (PRISE) | Dizziness on standing | 1 Participants |
| Harmine Hydrochloride 100mg | Patient Rated Inventory of Side Effects (PRISE) | Difficulty sleeping | 0 Participants |
| Harmine Hydrochloride 100mg | Patient Rated Inventory of Side Effects (PRISE) | Increased perspiration | 0 Participants |
| Harmine Hydrochloride 100mg | Patient Rated Inventory of Side Effects (PRISE) | Poor concentration | 2 Participants |
| Harmine Hydrochloride 100mg | Patient Rated Inventory of Side Effects (PRISE) | Dizziness | 3 Participants |
| Harmine Hydrochloride 100mg | Patient Rated Inventory of Side Effects (PRISE) | Ringing in ears | 0 Participants |
| Harmine Hydrochloride 100mg | Patient Rated Inventory of Side Effects (PRISE) | Headache | 2 Participants |
| Harmine Hydrochloride 100mg | Patient Rated Inventory of Side Effects (PRISE) | Fatigue | 4 Participants |
| Harmine Hydrochloride 200mg | Patient Rated Inventory of Side Effects (PRISE) | General malaise | 1 Participants |
| Harmine Hydrochloride 200mg | Patient Rated Inventory of Side Effects (PRISE) | Decreased energy | 8 Participants |
| Harmine Hydrochloride 200mg | Patient Rated Inventory of Side Effects (PRISE) | Fatigue | 9 Participants |
| Harmine Hydrochloride 200mg | Patient Rated Inventory of Side Effects (PRISE) | Dizziness | 5 Participants |
| Harmine Hydrochloride 200mg | Patient Rated Inventory of Side Effects (PRISE) | Nausea/vomiting | 5 Participants |
| Harmine Hydrochloride 200mg | Patient Rated Inventory of Side Effects (PRISE) | Dizziness on standing | 3 Participants |
| Harmine Hydrochloride 200mg | Patient Rated Inventory of Side Effects (PRISE) | Poor concentration | 3 Participants |
| Harmine Hydrochloride 200mg | Patient Rated Inventory of Side Effects (PRISE) | Headache | 4 Participants |
| Harmine Hydrochloride 200mg | Patient Rated Inventory of Side Effects (PRISE) | Poor coordination | 3 Participants |
| Harmine Hydrochloride 200mg | Patient Rated Inventory of Side Effects (PRISE) | Anxiety | 1 Participants |
| Harmine Hydrochloride 200mg | Patient Rated Inventory of Side Effects (PRISE) | Restlessness | 1 Participants |
| Harmine Hydrochloride 200mg | Patient Rated Inventory of Side Effects (PRISE) | Palpitations | 2 Participants |
| Harmine Hydrochloride 200mg | Patient Rated Inventory of Side Effects (PRISE) | Dry mouth | 1 Participants |
| Harmine Hydrochloride 200mg | Patient Rated Inventory of Side Effects (PRISE) | Sleeping too much | 2 Participants |
| Harmine Hydrochloride 200mg | Patient Rated Inventory of Side Effects (PRISE) | Tremors | 3 Participants |
| Harmine Hydrochloride 200mg | Patient Rated Inventory of Side Effects (PRISE) | Blurred vision | 3 Participants |
| Harmine Hydrochloride 200mg | Patient Rated Inventory of Side Effects (PRISE) | Ringing in ears | 0 Participants |
| Harmine Hydrochloride 200mg | Patient Rated Inventory of Side Effects (PRISE) | Increased perspiration | 1 Participants |
| Harmine Hydrochloride 200mg | Patient Rated Inventory of Side Effects (PRISE) | Difficulty sleeping | 1 Participants |
| Harmine Hydrochloride 200mg | Patient Rated Inventory of Side Effects (PRISE) | Constipation | 0 Participants |
| Harmine Hydrochloride 300mg | Patient Rated Inventory of Side Effects (PRISE) | Fatigue | 3 Participants |
| Harmine Hydrochloride 300mg | Patient Rated Inventory of Side Effects (PRISE) | Tremors | 0 Participants |
| Harmine Hydrochloride 300mg | Patient Rated Inventory of Side Effects (PRISE) | Headache | 1 Participants |
| Harmine Hydrochloride 300mg | Patient Rated Inventory of Side Effects (PRISE) | Constipation | 0 Participants |
| Harmine Hydrochloride 300mg | Patient Rated Inventory of Side Effects (PRISE) | Blurred vision | 0 Participants |
| Harmine Hydrochloride 300mg | Patient Rated Inventory of Side Effects (PRISE) | Poor concentration | 3 Participants |
| Harmine Hydrochloride 300mg | Patient Rated Inventory of Side Effects (PRISE) | Difficulty sleeping | 0 Participants |
| Harmine Hydrochloride 300mg | Patient Rated Inventory of Side Effects (PRISE) | Ringing in ears | 2 Participants |
| Harmine Hydrochloride 300mg | Patient Rated Inventory of Side Effects (PRISE) | Dizziness on standing | 5 Participants |
| Harmine Hydrochloride 300mg | Patient Rated Inventory of Side Effects (PRISE) | Decreased energy | 5 Participants |
| Harmine Hydrochloride 300mg | Patient Rated Inventory of Side Effects (PRISE) | Increased perspiration | 1 Participants |
| Harmine Hydrochloride 300mg | Patient Rated Inventory of Side Effects (PRISE) | Nausea/vomiting | 5 Participants |
| Harmine Hydrochloride 300mg | Patient Rated Inventory of Side Effects (PRISE) | Palpitations | 1 Participants |
| Harmine Hydrochloride 300mg | Patient Rated Inventory of Side Effects (PRISE) | Restlessness | 1 Participants |
| Harmine Hydrochloride 300mg | Patient Rated Inventory of Side Effects (PRISE) | Dizziness | 5 Participants |
| Harmine Hydrochloride 300mg | Patient Rated Inventory of Side Effects (PRISE) | Dry mouth | 1 Participants |
| Harmine Hydrochloride 300mg | Patient Rated Inventory of Side Effects (PRISE) | Anxiety | 2 Participants |
| Harmine Hydrochloride 300mg | Patient Rated Inventory of Side Effects (PRISE) | General malaise | 0 Participants |
| Harmine Hydrochloride 300mg | Patient Rated Inventory of Side Effects (PRISE) | Sleeping too much | 1 Participants |
| Harmine Hydrochloride 300mg | Patient Rated Inventory of Side Effects (PRISE) | Poor coordination | 2 Participants |
Secondary
Perceived Stress Scale (PSS)
The PSS is a 10-item self-report scale that measures the perception of stress. Each item is rated on a scale from 0-4. Full scale from 0-40, with higher score indicating more perceived stress
Time frame: 24 hours
Population: 300mg and 500mg arm combined
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Harmine Hydrochloride 100mg | Perceived Stress Scale (PSS) | 8 hours | 5.7 score on a scale |
| Harmine Hydrochloride 100mg | Perceived Stress Scale (PSS) | 7 hours | 6.3 score on a scale |
| Harmine Hydrochloride 100mg | Perceived Stress Scale (PSS) | Baseline | 5.7 score on a scale |
| Harmine Hydrochloride 100mg | Perceived Stress Scale (PSS) | 6 hours | 6.8 score on a scale |
| Harmine Hydrochloride 100mg | Perceived Stress Scale (PSS) | 24 hours | 6.2 score on a scale |
| Harmine Hydrochloride 200mg | Perceived Stress Scale (PSS) | 7 hours | 7.8 score on a scale |
| Harmine Hydrochloride 200mg | Perceived Stress Scale (PSS) | Baseline | 7.1 score on a scale |
| Harmine Hydrochloride 200mg | Perceived Stress Scale (PSS) | 6 hours | 7.2 score on a scale |
| Harmine Hydrochloride 200mg | Perceived Stress Scale (PSS) | 8 hours | 8.5 score on a scale |
| Harmine Hydrochloride 200mg | Perceived Stress Scale (PSS) | 24 hours | 7.8 score on a scale |
| Harmine Hydrochloride 300mg | Perceived Stress Scale (PSS) | 24 hours | 6.6 score on a scale |
| Harmine Hydrochloride 300mg | Perceived Stress Scale (PSS) | 8 hours | 5.2 score on a scale |
| Harmine Hydrochloride 300mg | Perceived Stress Scale (PSS) | Baseline | 5.8 score on a scale |
| Harmine Hydrochloride 300mg | Perceived Stress Scale (PSS) | 7 hours | 5.6 score on a scale |
| Harmine Hydrochloride 300mg | Perceived Stress Scale (PSS) | 6 hours | 4.8 score on a scale |
Secondary
Profile of Mood States Bipolar Scale (POMS-Bi): Agreeable-Hostile Scale
The POMS-Bi is a 72-item psychological self-report rating scale used to assess transient, distinct mood states. It is also a validated instrument for identifying the effects of drug treatments. Items are rated on a four-point scale from 0 much unlike this to 3 much like this. It includes six bipolar scales: composed-anxious, agreeable-hostile, elated-depressed, confident-unsure, energetic-tired, and clearheaded-confused. Each subscale is scored 0-36, with higher scores associated with better mood
Time frame: Baseline, 2, 6, 7, 8, and 24 hours
Population: 300mg and 500mg arm combined
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Harmine Hydrochloride 100mg | Profile of Mood States Bipolar Scale (POMS-Bi): Agreeable-Hostile Scale | Baseline | 31.5 score on a scale |
| Harmine Hydrochloride 100mg | Profile of Mood States Bipolar Scale (POMS-Bi): Agreeable-Hostile Scale | 2 hours | 30.0 score on a scale |
| Harmine Hydrochloride 100mg | Profile of Mood States Bipolar Scale (POMS-Bi): Agreeable-Hostile Scale | 6 hours | 31.1 score on a scale |
| Harmine Hydrochloride 100mg | Profile of Mood States Bipolar Scale (POMS-Bi): Agreeable-Hostile Scale | 7 hours | 31.8 score on a scale |
| Harmine Hydrochloride 100mg | Profile of Mood States Bipolar Scale (POMS-Bi): Agreeable-Hostile Scale | 8 hours | 32.2 score on a scale |
| Harmine Hydrochloride 100mg | Profile of Mood States Bipolar Scale (POMS-Bi): Agreeable-Hostile Scale | 24 hours | 33.0 score on a scale |
| Harmine Hydrochloride 200mg | Profile of Mood States Bipolar Scale (POMS-Bi): Agreeable-Hostile Scale | 24 hours | 27.6 score on a scale |
| Harmine Hydrochloride 200mg | Profile of Mood States Bipolar Scale (POMS-Bi): Agreeable-Hostile Scale | Baseline | 28.7 score on a scale |
| Harmine Hydrochloride 200mg | Profile of Mood States Bipolar Scale (POMS-Bi): Agreeable-Hostile Scale | 7 hours | 27.0 score on a scale |
| Harmine Hydrochloride 200mg | Profile of Mood States Bipolar Scale (POMS-Bi): Agreeable-Hostile Scale | 8 hours | 27.7 score on a scale |
| Harmine Hydrochloride 200mg | Profile of Mood States Bipolar Scale (POMS-Bi): Agreeable-Hostile Scale | 2 hours | 28.1 score on a scale |
| Harmine Hydrochloride 200mg | Profile of Mood States Bipolar Scale (POMS-Bi): Agreeable-Hostile Scale | 6 hours | 28.1 score on a scale |
| Harmine Hydrochloride 300mg | Profile of Mood States Bipolar Scale (POMS-Bi): Agreeable-Hostile Scale | 2 hours | 29.2 score on a scale |
| Harmine Hydrochloride 300mg | Profile of Mood States Bipolar Scale (POMS-Bi): Agreeable-Hostile Scale | 6 hours | 30.6 score on a scale |
| Harmine Hydrochloride 300mg | Profile of Mood States Bipolar Scale (POMS-Bi): Agreeable-Hostile Scale | 24 hours | 29.8 score on a scale |
| Harmine Hydrochloride 300mg | Profile of Mood States Bipolar Scale (POMS-Bi): Agreeable-Hostile Scale | 7 hours | 30.6 score on a scale |
| Harmine Hydrochloride 300mg | Profile of Mood States Bipolar Scale (POMS-Bi): Agreeable-Hostile Scale | Baseline | 31.6 score on a scale |
| Harmine Hydrochloride 300mg | Profile of Mood States Bipolar Scale (POMS-Bi): Agreeable-Hostile Scale | 8 hours | 30.0 score on a scale |
Secondary
Profile of Mood States Bipolar Scale (POMS-Bi): Clearheaded-Confused Scale
The POMS-Bi is a 72-item psychological self-report rating scale used to assess transient, distinct mood states. It is also a validated instrument for identifying the effects of drug treatments. Items are rated on a four-point scale from 0 much unlike this to 3 much like this. It includes six bipolar scales: composed-anxious, agreeable-hostile, elated-depressed, confident-unsure, energetic-tired, and clearheaded-confused. Each subscale is scored 0-36, with higher scores associated with better mood
Time frame: Baseline, 2, 6, 7, 8, and 24 hours
Population: 300mg and 500mg arm combined
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Harmine Hydrochloride 100mg | Profile of Mood States Bipolar Scale (POMS-Bi): Clearheaded-Confused Scale | 8 hours | 31.2 score on a scale |
| Harmine Hydrochloride 100mg | Profile of Mood States Bipolar Scale (POMS-Bi): Clearheaded-Confused Scale | 6 hours | 30.3 score on a scale |
| Harmine Hydrochloride 100mg | Profile of Mood States Bipolar Scale (POMS-Bi): Clearheaded-Confused Scale | 24 hours | 32.4 score on a scale |
| Harmine Hydrochloride 100mg | Profile of Mood States Bipolar Scale (POMS-Bi): Clearheaded-Confused Scale | Baseline | 31.1 score on a scale |
| Harmine Hydrochloride 100mg | Profile of Mood States Bipolar Scale (POMS-Bi): Clearheaded-Confused Scale | 7 hours | 30.6 score on a scale |
| Harmine Hydrochloride 100mg | Profile of Mood States Bipolar Scale (POMS-Bi): Clearheaded-Confused Scale | 2 hours | 29.0 score on a scale |
| Harmine Hydrochloride 200mg | Profile of Mood States Bipolar Scale (POMS-Bi): Clearheaded-Confused Scale | 7 hours | 26.9 score on a scale |
| Harmine Hydrochloride 200mg | Profile of Mood States Bipolar Scale (POMS-Bi): Clearheaded-Confused Scale | 8 hours | 26.6 score on a scale |
| Harmine Hydrochloride 200mg | Profile of Mood States Bipolar Scale (POMS-Bi): Clearheaded-Confused Scale | 2 hours | 24.7 score on a scale |
| Harmine Hydrochloride 200mg | Profile of Mood States Bipolar Scale (POMS-Bi): Clearheaded-Confused Scale | 24 hours | 28.3 score on a scale |
| Harmine Hydrochloride 200mg | Profile of Mood States Bipolar Scale (POMS-Bi): Clearheaded-Confused Scale | Baseline | 27.9 score on a scale |
| Harmine Hydrochloride 200mg | Profile of Mood States Bipolar Scale (POMS-Bi): Clearheaded-Confused Scale | 6 hours | 27.5 score on a scale |
| Harmine Hydrochloride 300mg | Profile of Mood States Bipolar Scale (POMS-Bi): Clearheaded-Confused Scale | 24 hours | 30.0 score on a scale |
| Harmine Hydrochloride 300mg | Profile of Mood States Bipolar Scale (POMS-Bi): Clearheaded-Confused Scale | Baseline | 31.2 score on a scale |
| Harmine Hydrochloride 300mg | Profile of Mood States Bipolar Scale (POMS-Bi): Clearheaded-Confused Scale | 2 hours | 22.2 score on a scale |
| Harmine Hydrochloride 300mg | Profile of Mood States Bipolar Scale (POMS-Bi): Clearheaded-Confused Scale | 6 hours | 29.6 score on a scale |
| Harmine Hydrochloride 300mg | Profile of Mood States Bipolar Scale (POMS-Bi): Clearheaded-Confused Scale | 7 hours | 27.8 score on a scale |
| Harmine Hydrochloride 300mg | Profile of Mood States Bipolar Scale (POMS-Bi): Clearheaded-Confused Scale | 8 hours | 28.6 score on a scale |
Secondary
Profile of Mood States Bipolar Scale (POMS-Bi): Composed-Anxious Scale
The POMS-Bi is a 72-item psychological self-report rating scale used to assess transient, distinct mood states. It is also a validated instrument for identifying the effects of drug treatments. Items are rated on a four-point scale from 0 much unlike this to 3 much like this. It includes six bipolar scales: composed-anxious, agreeable-hostile, elated-depressed, confident-unsure, energetic-tired, and clearheaded-confused. Each subscale is scored 0-36, with higher scores associated with better mood
Time frame: Baseline, 2, 6, 7, 8, and 24 hours
Population: 300mg and 500mg arm combined
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Harmine Hydrochloride 100mg | Profile of Mood States Bipolar Scale (POMS-Bi): Composed-Anxious Scale | Baseline | 33.9 score on a scale |
| Harmine Hydrochloride 100mg | Profile of Mood States Bipolar Scale (POMS-Bi): Composed-Anxious Scale | 2 hours | 31.7 score on a scale |
| Harmine Hydrochloride 100mg | Profile of Mood States Bipolar Scale (POMS-Bi): Composed-Anxious Scale | 6 hours | 31.9 score on a scale |
| Harmine Hydrochloride 100mg | Profile of Mood States Bipolar Scale (POMS-Bi): Composed-Anxious Scale | 7 hours | 33.5 score on a scale |
| Harmine Hydrochloride 100mg | Profile of Mood States Bipolar Scale (POMS-Bi): Composed-Anxious Scale | 8 hours | 32.7 score on a scale |
| Harmine Hydrochloride 100mg | Profile of Mood States Bipolar Scale (POMS-Bi): Composed-Anxious Scale | 24 hours | 33.1 score on a scale |
| Harmine Hydrochloride 200mg | Profile of Mood States Bipolar Scale (POMS-Bi): Composed-Anxious Scale | 24 hours | 29.3 score on a scale |
| Harmine Hydrochloride 200mg | Profile of Mood States Bipolar Scale (POMS-Bi): Composed-Anxious Scale | Baseline | 29.3 score on a scale |
| Harmine Hydrochloride 200mg | Profile of Mood States Bipolar Scale (POMS-Bi): Composed-Anxious Scale | 7 hours | 29.1 score on a scale |
| Harmine Hydrochloride 200mg | Profile of Mood States Bipolar Scale (POMS-Bi): Composed-Anxious Scale | 8 hours | 29.2 score on a scale |
| Harmine Hydrochloride 200mg | Profile of Mood States Bipolar Scale (POMS-Bi): Composed-Anxious Scale | 2 hours | 28.5 score on a scale |
| Harmine Hydrochloride 200mg | Profile of Mood States Bipolar Scale (POMS-Bi): Composed-Anxious Scale | 6 hours | 30.7 score on a scale |
| Harmine Hydrochloride 300mg | Profile of Mood States Bipolar Scale (POMS-Bi): Composed-Anxious Scale | 2 hours | 29 score on a scale |
| Harmine Hydrochloride 300mg | Profile of Mood States Bipolar Scale (POMS-Bi): Composed-Anxious Scale | 6 hours | 33.6 score on a scale |
| Harmine Hydrochloride 300mg | Profile of Mood States Bipolar Scale (POMS-Bi): Composed-Anxious Scale | 24 hours | 33.0 score on a scale |
| Harmine Hydrochloride 300mg | Profile of Mood States Bipolar Scale (POMS-Bi): Composed-Anxious Scale | 7 hours | 32.8 score on a scale |
| Harmine Hydrochloride 300mg | Profile of Mood States Bipolar Scale (POMS-Bi): Composed-Anxious Scale | Baseline | 33.6 score on a scale |
| Harmine Hydrochloride 300mg | Profile of Mood States Bipolar Scale (POMS-Bi): Composed-Anxious Scale | 8 hours | 31.4 score on a scale |
Secondary
Profile of Mood States Bipolar Scale (POMS-Bi): Confident-Unsure Scale
The POMS-Bi is a 72-item psychological self-report rating scale used to assess transient, distinct mood states. It is also a validated instrument for identifying the effects of drug treatments. Items are rated on a four-point scale from 0 much unlike this to 3 much like this. It includes six bipolar scales: composed-anxious, agreeable-hostile, elated-depressed, confident-unsure, energetic-tired, and clearheaded-confused. Each subscale is scored 0-36, with higher scores associated with better mood
Time frame: Baseline, 2, 6, 7, 8, and 24 hours
Population: 300mg and 500mg arm combined
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Harmine Hydrochloride 100mg | Profile of Mood States Bipolar Scale (POMS-Bi): Confident-Unsure Scale | Baseline | 27.4 score on a scale |
| Harmine Hydrochloride 100mg | Profile of Mood States Bipolar Scale (POMS-Bi): Confident-Unsure Scale | 2 hours | 24.8 score on a scale |
| Harmine Hydrochloride 100mg | Profile of Mood States Bipolar Scale (POMS-Bi): Confident-Unsure Scale | 6 hours | 26.5 score on a scale |
| Harmine Hydrochloride 100mg | Profile of Mood States Bipolar Scale (POMS-Bi): Confident-Unsure Scale | 7 hours | 27.1 score on a scale |
| Harmine Hydrochloride 100mg | Profile of Mood States Bipolar Scale (POMS-Bi): Confident-Unsure Scale | 8 hours | 27.0 score on a scale |
| Harmine Hydrochloride 100mg | Profile of Mood States Bipolar Scale (POMS-Bi): Confident-Unsure Scale | 24 hours | 29.0 score on a scale |
| Harmine Hydrochloride 200mg | Profile of Mood States Bipolar Scale (POMS-Bi): Confident-Unsure Scale | 24 hours | 24.6 score on a scale |
| Harmine Hydrochloride 200mg | Profile of Mood States Bipolar Scale (POMS-Bi): Confident-Unsure Scale | Baseline | 24.3 score on a scale |
| Harmine Hydrochloride 200mg | Profile of Mood States Bipolar Scale (POMS-Bi): Confident-Unsure Scale | 7 hours | 22.9 score on a scale |
| Harmine Hydrochloride 200mg | Profile of Mood States Bipolar Scale (POMS-Bi): Confident-Unsure Scale | 8 hours | 23.2 score on a scale |
| Harmine Hydrochloride 200mg | Profile of Mood States Bipolar Scale (POMS-Bi): Confident-Unsure Scale | 2 hours | 22.6 score on a scale |
| Harmine Hydrochloride 200mg | Profile of Mood States Bipolar Scale (POMS-Bi): Confident-Unsure Scale | 6 hours | 24.5 score on a scale |
| Harmine Hydrochloride 300mg | Profile of Mood States Bipolar Scale (POMS-Bi): Confident-Unsure Scale | 2 hours | 21.6 score on a scale |
| Harmine Hydrochloride 300mg | Profile of Mood States Bipolar Scale (POMS-Bi): Confident-Unsure Scale | 6 hours | 22.4 score on a scale |
| Harmine Hydrochloride 300mg | Profile of Mood States Bipolar Scale (POMS-Bi): Confident-Unsure Scale | 24 hours | 26.0 score on a scale |
| Harmine Hydrochloride 300mg | Profile of Mood States Bipolar Scale (POMS-Bi): Confident-Unsure Scale | 7 hours | 23.4 score on a scale |
| Harmine Hydrochloride 300mg | Profile of Mood States Bipolar Scale (POMS-Bi): Confident-Unsure Scale | Baseline | 27.4 score on a scale |
| Harmine Hydrochloride 300mg | Profile of Mood States Bipolar Scale (POMS-Bi): Confident-Unsure Scale | 8 hours | 24 score on a scale |
Secondary
Profile of Mood States Bipolar Scale (POMS-Bi): Elated-Depression Scale
The POMS-Bi is a 72-item psychological self-report rating scale used to assess transient, distinct mood states. It is also a validated instrument for identifying the effects of drug treatments. Items are rated on a four-point scale from 0 much unlike this to 3 much like this. It includes six bipolar scales: composed-anxious, agreeable-hostile, elated-depressed, confident-unsure, energetic-tired, and clearheaded-confused. Each subscale is scored 0-36, with higher scores associated with better mood
Time frame: Baseline, 2, 6, 7, 8, and 24 hours
Population: 300mg and 500mg arm combined
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Harmine Hydrochloride 100mg | Profile of Mood States Bipolar Scale (POMS-Bi): Elated-Depression Scale | Baseline | 29.1 score on a scale |
| Harmine Hydrochloride 100mg | Profile of Mood States Bipolar Scale (POMS-Bi): Elated-Depression Scale | 2 hours | 28.1 score on a scale |
| Harmine Hydrochloride 100mg | Profile of Mood States Bipolar Scale (POMS-Bi): Elated-Depression Scale | 6 hours | 29.0 score on a scale |
| Harmine Hydrochloride 100mg | Profile of Mood States Bipolar Scale (POMS-Bi): Elated-Depression Scale | 7 hours | 28.9 score on a scale |
| Harmine Hydrochloride 100mg | Profile of Mood States Bipolar Scale (POMS-Bi): Elated-Depression Scale | 8 hours | 29.8 score on a scale |
| Harmine Hydrochloride 100mg | Profile of Mood States Bipolar Scale (POMS-Bi): Elated-Depression Scale | 24 hours | 31.4 score on a scale |
| Harmine Hydrochloride 200mg | Profile of Mood States Bipolar Scale (POMS-Bi): Elated-Depression Scale | 24 hours | 25.5 score on a scale |
| Harmine Hydrochloride 200mg | Profile of Mood States Bipolar Scale (POMS-Bi): Elated-Depression Scale | Baseline | 25.6 score on a scale |
| Harmine Hydrochloride 200mg | Profile of Mood States Bipolar Scale (POMS-Bi): Elated-Depression Scale | 7 hours | 24.7 score on a scale |
| Harmine Hydrochloride 200mg | Profile of Mood States Bipolar Scale (POMS-Bi): Elated-Depression Scale | 8 hours | 25.0 score on a scale |
| Harmine Hydrochloride 200mg | Profile of Mood States Bipolar Scale (POMS-Bi): Elated-Depression Scale | 2 hours | 24.6 score on a scale |
| Harmine Hydrochloride 200mg | Profile of Mood States Bipolar Scale (POMS-Bi): Elated-Depression Scale | 6 hours | 25.8 score on a scale |
| Harmine Hydrochloride 300mg | Profile of Mood States Bipolar Scale (POMS-Bi): Elated-Depression Scale | 2 hours | 24.6 score on a scale |
| Harmine Hydrochloride 300mg | Profile of Mood States Bipolar Scale (POMS-Bi): Elated-Depression Scale | 6 hours | 27.2 score on a scale |
| Harmine Hydrochloride 300mg | Profile of Mood States Bipolar Scale (POMS-Bi): Elated-Depression Scale | 24 hours | 26.0 score on a scale |
| Harmine Hydrochloride 300mg | Profile of Mood States Bipolar Scale (POMS-Bi): Elated-Depression Scale | 7 hours | 25.6 score on a scale |
| Harmine Hydrochloride 300mg | Profile of Mood States Bipolar Scale (POMS-Bi): Elated-Depression Scale | Baseline | 27.0 score on a scale |
| Harmine Hydrochloride 300mg | Profile of Mood States Bipolar Scale (POMS-Bi): Elated-Depression Scale | 8 hours | 26.0 score on a scale |
Secondary
Profile of Mood States Bipolar Scale (POMS-Bi): Energetic-Tired Scale
The POMS-Bi is a 72-item psychological self-report rating scale used to assess transient, distinct mood states. It is also a validated instrument for identifying the effects of drug treatments. Items are rated on a four-point scale from 0 much unlike this to 3 much like this. It includes six bipolar scales: composed-anxious, agreeable-hostile, elated-depressed, confident-unsure, energetic-tired, and clearheaded-confused. Each subscale is scored 0-36, with higher scores associated with better mood
Time frame: Baseline, 2, 6, 7, 8, and 24 hours
Population: 300mg and 500mg arm combined
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Harmine Hydrochloride 100mg | Profile of Mood States Bipolar Scale (POMS-Bi): Energetic-Tired Scale | Baseline | 24.5 score on a scale |
| Harmine Hydrochloride 100mg | Profile of Mood States Bipolar Scale (POMS-Bi): Energetic-Tired Scale | 2 hours | 22.0 score on a scale |
| Harmine Hydrochloride 100mg | Profile of Mood States Bipolar Scale (POMS-Bi): Energetic-Tired Scale | 6 hours | 23.1 score on a scale |
| Harmine Hydrochloride 100mg | Profile of Mood States Bipolar Scale (POMS-Bi): Energetic-Tired Scale | 7 hours | 23.5 score on a scale |
| Harmine Hydrochloride 100mg | Profile of Mood States Bipolar Scale (POMS-Bi): Energetic-Tired Scale | 8 hours | 26.1 score on a scale |
| Harmine Hydrochloride 100mg | Profile of Mood States Bipolar Scale (POMS-Bi): Energetic-Tired Scale | 24 hours | 29.3 score on a scale |
| Harmine Hydrochloride 200mg | Profile of Mood States Bipolar Scale (POMS-Bi): Energetic-Tired Scale | 24 hours | 24.0 score on a scale |
| Harmine Hydrochloride 200mg | Profile of Mood States Bipolar Scale (POMS-Bi): Energetic-Tired Scale | Baseline | 20.9 score on a scale |
| Harmine Hydrochloride 200mg | Profile of Mood States Bipolar Scale (POMS-Bi): Energetic-Tired Scale | 7 hours | 20.2 score on a scale |
| Harmine Hydrochloride 200mg | Profile of Mood States Bipolar Scale (POMS-Bi): Energetic-Tired Scale | 8 hours | 20.5 score on a scale |
| Harmine Hydrochloride 200mg | Profile of Mood States Bipolar Scale (POMS-Bi): Energetic-Tired Scale | 2 hours | 14.5 score on a scale |
| Harmine Hydrochloride 200mg | Profile of Mood States Bipolar Scale (POMS-Bi): Energetic-Tired Scale | 6 hours | 20.1 score on a scale |
| Harmine Hydrochloride 300mg | Profile of Mood States Bipolar Scale (POMS-Bi): Energetic-Tired Scale | 2 hours | 7.2 score on a scale |
| Harmine Hydrochloride 300mg | Profile of Mood States Bipolar Scale (POMS-Bi): Energetic-Tired Scale | 6 hours | 19.6 score on a scale |
| Harmine Hydrochloride 300mg | Profile of Mood States Bipolar Scale (POMS-Bi): Energetic-Tired Scale | 24 hours | 20.8 score on a scale |
| Harmine Hydrochloride 300mg | Profile of Mood States Bipolar Scale (POMS-Bi): Energetic-Tired Scale | 7 hours | 16.2 score on a scale |
| Harmine Hydrochloride 300mg | Profile of Mood States Bipolar Scale (POMS-Bi): Energetic-Tired Scale | Baseline | 21.8 score on a scale |
| Harmine Hydrochloride 300mg | Profile of Mood States Bipolar Scale (POMS-Bi): Energetic-Tired Scale | 8 hours | 19.4 score on a scale |
Secondary
Visual Analog Scale (VAS) - Anxiety
Visual Analog Scale (VAS) to characterize psychoactive effects of harmine in healthy adults. Full scale from 0-10, with higher scores indicating subjective states are experienced more strongly
Time frame: baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7 8, and 24 hours
Population: 300mg and 500mg arm combined
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Anxiety | 6 hours | 0.28 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Anxiety | 7 hours | 0.19 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Anxiety | 1.5 hours | 0.59 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Anxiety | 8 hours | 0.17 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Anxiety | 24 hours | 0.31 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Anxiety | 0.5 hours | 0.33 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Anxiety | 2 hours | 0.53 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Anxiety | 3 hours | 0.42 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Anxiety | baseline | 0.38 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Anxiety | 4 hours | 0.38 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Anxiety | 1 hour | 1 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Anxiety | 5 hours | 0.24 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Anxiety | 1 hour | 1.03 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Anxiety | 6 hours | 0.51 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Anxiety | baseline | 1.01 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Anxiety | 2 hours | 0.78 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Anxiety | 7 hours | 0.53 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Anxiety | 0.5 hours | 0.79 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Anxiety | 4 hours | 0.55 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Anxiety | 8 hours | 0.62 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Anxiety | 1.5 hours | 0.76 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Anxiety | 3 hours | 0.54 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Anxiety | 24 hours | 0.57 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Anxiety | 5 hours | 0.58 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Anxiety | 24 hours | 0.14 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Anxiety | 0.5 hours | 2.58 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Anxiety | 1 hour | 1.56 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Anxiety | 1.5 hours | 0.70 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Anxiety | 2 hours | 0.22 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Anxiety | 3 hours | 0.08 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Anxiety | 4 hours | 0.28 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Anxiety | 5 hours | 0.26 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Anxiety | 6 hours | 0.20 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Anxiety | 7 hours | 0.04 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Anxiety | 8 hours | 0.12 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Anxiety | baseline | 0.42 score on a scale |
Secondary
Visual Analog Scale (VAS) - Depressed Mood
Visual Analog Scale (VAS) to characterize psychoactive effects of harmine in healthy adults. Full scale from 0-10, with higher scores indicating subjective states are experienced more strongly.
Time frame: baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7 8, and 24 hours
Population: 300mg and 500mg arm combined
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Depressed Mood | baseline | 0.19 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Depressed Mood | 0.5 hours | 1.18 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Depressed Mood | 1 hour | 0.26 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Depressed Mood | 1.5 hours | 0.28 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Depressed Mood | 2 hours | 0.64 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Depressed Mood | 3 hours | 0.22 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Depressed Mood | 4 hours | 0.24 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Depressed Mood | 5 hours | 0.22 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Depressed Mood | 6 hours | 0.20 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Depressed Mood | 7 hours | 0.31 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Depressed Mood | 8 hours | 0.20 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Depressed Mood | 24 hours | 0.20 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Depressed Mood | 24 hours | 0.33 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Depressed Mood | baseline | 0.33 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Depressed Mood | 4 hours | 0.38 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Depressed Mood | 6 hours | 0.18 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Depressed Mood | 0.5 hours | 0.41 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Depressed Mood | 3 hours | 0.36 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Depressed Mood | 8 hours | 0.31 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Depressed Mood | 1 hour | 0.28 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Depressed Mood | 5 hours | 0.28 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Depressed Mood | 2 hours | 0.38 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Depressed Mood | 1.5 hours | 0.44 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Depressed Mood | 7 hours | 0.29 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Depressed Mood | 1.5 hours | 0.24 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Depressed Mood | 2 hours | 0.10 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Depressed Mood | 7 hours | 0.12 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Depressed Mood | 3 hours | 0.14 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Depressed Mood | 4 hours | 0.28 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Depressed Mood | 5 hours | 0.84 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Depressed Mood | 8 hours | 0.16 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Depressed Mood | baseline | 0.38 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Depressed Mood | 0.5 hours | 0.16 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Depressed Mood | 6 hours | 0.16 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Depressed Mood | 1 hour | 0.46 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Depressed Mood | 24 hours | 0.12 score on a scale |
Secondary
Visual Analog Scale (VAS) - Drowsiness
Visual Analog Scale (VAS) to characterize psychoactive effects of harmine in healthy adults. Full scale from 0-10, with higher scores indicating subjective states are experienced more strongly
Time frame: baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7 8, and 24 hours
Population: 300mg and 500mg arm combined
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Drowsiness | baseline | 1.43 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Drowsiness | 0.5 hours | 1.98 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Drowsiness | 1 hour | 2.54 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Drowsiness | 1.5 hours | 2.58 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Drowsiness | 2 hours | 1.97 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Drowsiness | 3 hours | 1.58 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Drowsiness | 4 hours | 2.29 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Drowsiness | 5 hours | 1.10 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Drowsiness | 6 hours | 1.86 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Drowsiness | 7 hours | 1.75 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Drowsiness | 8 hours | 1.43 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Drowsiness | 24 hours | 1.80 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Drowsiness | 24 hours | 1.00 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Drowsiness | baseline | 2.14 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Drowsiness | 4 hours | 2.56 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Drowsiness | 6 hours | 1.73 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Drowsiness | 0.5 hours | 3.04 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Drowsiness | 3 hours | 3.24 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Drowsiness | 8 hours | 2.20 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Drowsiness | 1 hour | 3.02 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Drowsiness | 5 hours | 1.86 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Drowsiness | 2 hours | 3.86 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Drowsiness | 1.5 hours | 3.96 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Drowsiness | 7 hours | 1.77 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Drowsiness | 1.5 hours | 4.50 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Drowsiness | 2 hours | 4.72 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Drowsiness | 7 hours | 2.92 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Drowsiness | 3 hours | 3.46 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Drowsiness | 4 hours | 3.32 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Drowsiness | 5 hours | 2.50 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Drowsiness | 8 hours | 2.20 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Drowsiness | baseline | 2.46 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Drowsiness | 0.5 hours | 3.10 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Drowsiness | 6 hours | 0.96 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Drowsiness | 1 hour | 3.60 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Drowsiness | 24 hours | 2.68 score on a scale |
Secondary
Visual Analog Scale (VAS) - Excitement
Visual Analog Scale (VAS) to characterize psychoactive effects of harmine in healthy adults. Full scale from 0-10, with higher scores indicating subjective states are experienced more strongly.
Time frame: baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7 8, and 24 hours
Population: 300mg and 500mg arm combined
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Excitement | baseline | 2.55 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Excitement | 0.5 hours | 2.35 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Excitement | 1 hour | 2.66 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Excitement | 1.5 hours | 1.53 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Excitement | 2 hours | 2.37 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Excitement | 3 hours | 2.50 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Excitement | 4 hours | 2.49 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Excitement | 5 hours | 2.25 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Excitement | 6 hours | 3.21 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Excitement | 7 hours | 2.54 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Excitement | 8 hours | 2.58 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Excitement | 24 hours | 4.01 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Excitement | 24 hours | 2.35 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Excitement | baseline | 2.12 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Excitement | 4 hours | 2.29 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Excitement | 6 hours | 1.42 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Excitement | 0.5 hours | 1.44 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Excitement | 3 hours | 1.65 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Excitement | 8 hours | 1.39 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Excitement | 1 hour | 2.10 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Excitement | 5 hours | 2.17 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Excitement | 2 hours | 2.02 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Excitement | 1.5 hours | 1.89 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Excitement | 7 hours | 1.02 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Excitement | 1.5 hours | 2.48 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Excitement | 2 hours | 2.92 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Excitement | 7 hours | 2.68 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Excitement | 3 hours | 3.16 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Excitement | 4 hours | 2.76 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Excitement | 5 hours | 2.16 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Excitement | 8 hours | 2.70 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Excitement | baseline | 3.90 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Excitement | 0.5 hours | 3.92 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Excitement | 6 hours | 2.36 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Excitement | 1 hour | 3.46 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Excitement | 24 hours | 2.98 score on a scale |
Secondary
Visual Analog Scale (VAS) - Feeling High/Intoxicated
Visual Analog Scale (VAS) to characterize psychoactive effects of harmine in healthy adults. Full scale from 0-10, with higher scores indicating subjective states are experienced more strongly
Time frame: baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7 8, and 24 hours
Population: 300mg and 500mg arm combined
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Feeling High/Intoxicated | baseline | 0.80 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Feeling High/Intoxicated | 0.5 hours | 0.77 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Feeling High/Intoxicated | 1 hour | 1.09 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Feeling High/Intoxicated | 1.5 hours | 1.29 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Feeling High/Intoxicated | 2 hours | 0.18 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Feeling High/Intoxicated | 3 hours | 0.54 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Feeling High/Intoxicated | 4 hours | 0.84 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Feeling High/Intoxicated | 5 hours | 0.40 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Feeling High/Intoxicated | 6 hours | 0.53 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Feeling High/Intoxicated | 7 hours | 0.76 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Feeling High/Intoxicated | 8 hours | 0.56 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Feeling High/Intoxicated | 24 hours | 0.62 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Feeling High/Intoxicated | 24 hours | 0.54 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Feeling High/Intoxicated | baseline | 0.44 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Feeling High/Intoxicated | 4 hours | 0.57 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Feeling High/Intoxicated | 6 hours | 0.66 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Feeling High/Intoxicated | 0.5 hours | 0.88 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Feeling High/Intoxicated | 3 hours | 0.62 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Feeling High/Intoxicated | 8 hours | 0.86 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Feeling High/Intoxicated | 1 hour | 2.23 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Feeling High/Intoxicated | 5 hours | 0.49 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Feeling High/Intoxicated | 2 hours | 2.27 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Feeling High/Intoxicated | 1.5 hours | 2.43 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Feeling High/Intoxicated | 7 hours | 0.65 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Feeling High/Intoxicated | 1.5 hours | 3.1 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Feeling High/Intoxicated | 2 hours | 2.74 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Feeling High/Intoxicated | 7 hours | 0.12 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Feeling High/Intoxicated | 3 hours | 0.16 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Feeling High/Intoxicated | 4 hours | 0.22 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Feeling High/Intoxicated | 5 hours | 0.22 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Feeling High/Intoxicated | 8 hours | 0.14 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Feeling High/Intoxicated | baseline | 0.12 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Feeling High/Intoxicated | 0.5 hours | 3.52 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Feeling High/Intoxicated | 6 hours | 0.18 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Feeling High/Intoxicated | 1 hour | 4.52 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Feeling High/Intoxicated | 24 hours | 0.12 score on a scale |
Secondary
Visual Analog Scale (VAS) - Feeling of Control
Visual Analog Scale (VAS) to characterize psychoactive effects of harmine in healthy adults. Full scale from 0-10, with higher scores indicating subjective states are experienced more strongly.
Time frame: baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7 8, and 24 hours
Population: 300mg and 500mg arm combined
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Feeling of Control | baseline | 4.00 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Feeling of Control | 0.5 hours | 3.84 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Feeling of Control | 1 hour | 3.14 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Feeling of Control | 1.5 hours | 3.39 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Feeling of Control | 2 hours | 3.48 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Feeling of Control | 3 hours | 4.13 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Feeling of Control | 4 hours | 4.22 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Feeling of Control | 5 hours | 3.07 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Feeling of Control | 6 hours | 3.75 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Feeling of Control | 7 hours | 3.76 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Feeling of Control | 8 hours | 3.83 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Feeling of Control | 24 hours | 3.94 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Feeling of Control | 24 hours | 3.52 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Feeling of Control | baseline | 3.27 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Feeling of Control | 4 hours | 2.87 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Feeling of Control | 6 hours | 2.14 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Feeling of Control | 0.5 hours | 2.00 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Feeling of Control | 3 hours | 2.17 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Feeling of Control | 8 hours | 2.11 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Feeling of Control | 1 hour | 3.81 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Feeling of Control | 5 hours | 2.51 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Feeling of Control | 2 hours | 3.07 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Feeling of Control | 1.5 hours | 1.91 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Feeling of Control | 7 hours | 1.80 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Feeling of Control | 1.5 hours | 4.04 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Feeling of Control | 2 hours | 4.24 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Feeling of Control | 7 hours | 4.50 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Feeling of Control | 3 hours | 3.56 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Feeling of Control | 4 hours | 3.56 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Feeling of Control | 5 hours | 3.48 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Feeling of Control | 8 hours | 4.56 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Feeling of Control | baseline | 3.24 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Feeling of Control | 0.5 hours | 5.46 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Feeling of Control | 6 hours | 4.44 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Feeling of Control | 1 hour | 3.96 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Feeling of Control | 24 hours | 5.30 score on a scale |
Secondary
Visual Analog Scale (VAS) - Happy Mood
Visual Analog Scale (VAS) to characterize psychoactive effects of harmine in healthy adults. Full scale from 0-10, with higher scores indicating subjective states are experienced more strongly
Time frame: baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7 8, and 24 hours
Population: 300mg and 500mg arm combined
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Happy Mood | baseline | 6.13 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Happy Mood | 0.5 hours | 5.73 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Happy Mood | 1 hour | 5.63 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Happy Mood | 1.5 hours | 4.90 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Happy Mood | 2 hours | 5.34 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Happy Mood | 3 hours | 5.43 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Happy Mood | 4 hours | 5.70 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Happy Mood | 5 hours | 5.10 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Happy Mood | 6 hours | 5.07 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Happy Mood | 7 hours | 5.37 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Happy Mood | 8 hours | 5.70 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Happy Mood | 24 hours | 5.84 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Happy Mood | 24 hours | 4.85 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Happy Mood | baseline | 5.22 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Happy Mood | 4 hours | 4.50 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Happy Mood | 6 hours | 4.39 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Happy Mood | 0.5 hours | 4.28 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Happy Mood | 3 hours | 3.98 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Happy Mood | 8 hours | 4.19 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Happy Mood | 1 hour | 4.27 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Happy Mood | 5 hours | 4.34 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Happy Mood | 2 hours | 3.83 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Happy Mood | 1.5 hours | 4.45 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Happy Mood | 7 hours | 4.17 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Happy Mood | 1.5 hours | 3.94 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Happy Mood | 2 hours | 3.72 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Happy Mood | 7 hours | 4.32 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Happy Mood | 3 hours | 4.12 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Happy Mood | 4 hours | 5.22 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Happy Mood | 5 hours | 4.20 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Happy Mood | 8 hours | 4.36 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Happy Mood | baseline | 5.60 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Happy Mood | 0.5 hours | 5.50 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Happy Mood | 6 hours | 5.02 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Happy Mood | 1 hour | 4.80 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Happy Mood | 24 hours | 4.84 score on a scale |
Secondary
Visual Analog Scale (VAS) - Hunger
Visual Analog Scale (VAS) to characterize psychoactive effects of harmine in healthy adults. Full scale from 0-10, with higher scores indicating subjective states are experienced more strongly.
Time frame: baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7 8, and 24 hours
Population: 300mg and 500mg arm combined
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Hunger | baseline | 2.31 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Hunger | 0.5 hours | 4.10 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Hunger | 1 hour | 2.64 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Hunger | 1.5 hours | 5.39 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Hunger | 2 hours | 5.38 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Hunger | 3 hours | 4.68 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Hunger | 4 hours | 4.14 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Hunger | 5 hours | 2.56 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Hunger | 6 hours | 2.98 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Hunger | 7 hours | 3.66 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Hunger | 8 hours | 2.87 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Hunger | 24 hours | 3.95 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Hunger | 24 hours | 3.51 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Hunger | baseline | 3.91 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Hunger | 4 hours | 4.78 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Hunger | 6 hours | 2.02 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Hunger | 0.5 hours | 3.40 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Hunger | 3 hours | 4.65 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Hunger | 8 hours | 4.29 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Hunger | 1 hour | 3.58 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Hunger | 5 hours | 1.85 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Hunger | 2 hours | 4.74 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Hunger | 1.5 hours | 4.26 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Hunger | 7 hours | 3.35 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Hunger | 1.5 hours | 5.88 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Hunger | 2 hours | 4.94 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Hunger | 7 hours | 4.02 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Hunger | 3 hours | 5.36 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Hunger | 4 hours | 6.16 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Hunger | 5 hours | 2.54 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Hunger | 8 hours | 4.30 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Hunger | baseline | 2.96 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Hunger | 0.5 hours | 4.32 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Hunger | 6 hours | 3.86 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Hunger | 1 hour | 4.66 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Hunger | 24 hours | 4.74 score on a scale |
Secondary
Visual Analog Scale (VAS) - Nausea
Visual Analog Scale (VAS) to characterize psychoactive effects of harmine in healthy adults. Full scale from 0-10, with higher scores indicating subjective states are experienced more strongly
Time frame: baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7 8, and 24 hours
Population: 300mg and 500mg arm combined
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Nausea | 0.5 hours | 0.71 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Nausea | 2 hours | 0.69 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Nausea | 1.5 hours | 0.44 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Nausea | 8 hours | 0.23 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Nausea | 3 hours | 0.25 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Nausea | baseline | 0.13 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Nausea | 24 hours | 0.25 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Nausea | 4 hours | 0.37 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Nausea | 7 hours | 0.28 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Nausea | 1 hour | 0.39 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Nausea | 5 hours | 0.23 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Nausea | 6 hours | 0.24 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Nausea | 5 hours | 0.46 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Nausea | 6 hours | 0.29 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Nausea | 7 hours | 0.65 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Nausea | 8 hours | 0.39 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Nausea | 24 hours | 0.32 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Nausea | 1.5 hours | 2.25 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Nausea | 2 hours | 1.78 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Nausea | 0.5 hours | 0.80 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Nausea | 3 hours | 0.93 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Nausea | baseline | 0.33 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Nausea | 4 hours | 0.48 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Nausea | 1 hour | 2.40 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Nausea | 24 hours | 0.08 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Nausea | baseline | 0.10 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Nausea | 0.5 hours | 0.12 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Nausea | 1 hour | 2.30 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Nausea | 1.5 hours | 2.82 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Nausea | 2 hours | 2.22 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Nausea | 3 hours | 1.04 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Nausea | 4 hours | 0.94 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Nausea | 5 hours | 0.60 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Nausea | 6 hours | 0.16 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Nausea | 7 hours | 0.14 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Nausea | 8 hours | 0.16 score on a scale |
Secondary
Visual Analog Scale (VAS) - Vividness of Image
Visual Analog Scale (VAS) to characterize psychoactive effects of harmine in healthy adults. Full scale from 0-10, with higher scores indicating subjective states are experienced more strongly.
Time frame: baseline, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7 8, and 24 hours
Population: 300mg and 500mg arm combined
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Vividness of Image | baseline | 5.34 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Vividness of Image | 0.5 hours | 5.03 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Vividness of Image | 1 hour | 5.17 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Vividness of Image | 1.5 hours | 5.21 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Vividness of Image | 2 hours | 5.33 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Vividness of Image | 3 hours | 5.82 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Vividness of Image | 4 hours | 5.70 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Vividness of Image | 5 hours | 5.78 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Vividness of Image | 6 hours | 5.72 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Vividness of Image | 7 hours | 5.70 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Vividness of Image | 8 hours | 5.94 score on a scale |
| Harmine Hydrochloride 100mg | Visual Analog Scale (VAS) - Vividness of Image | 24 hours | 5.91 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Vividness of Image | 24 hours | 2.45 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Vividness of Image | baseline | 2.99 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Vividness of Image | 4 hours | 2.61 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Vividness of Image | 6 hours | 2.21 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Vividness of Image | 0.5 hours | 2.42 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Vividness of Image | 3 hours | 2.76 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Vividness of Image | 8 hours | 2.39 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Vividness of Image | 1 hour | 2.94 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Vividness of Image | 5 hours | 2.45 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Vividness of Image | 2 hours | 2.57 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Vividness of Image | 1.5 hours | 2.75 score on a scale |
| Harmine Hydrochloride 200mg | Visual Analog Scale (VAS) - Vividness of Image | 7 hours | 2.17 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Vividness of Image | 1.5 hours | 3.76 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Vividness of Image | 2 hours | 3.24 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Vividness of Image | 7 hours | 2.16 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Vividness of Image | 3 hours | 2.04 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Vividness of Image | 4 hours | 2.32 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Vividness of Image | 5 hours | 2.02 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Vividness of Image | 8 hours | 2.50 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Vividness of Image | baseline | 2.10 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Vividness of Image | 0.5 hours | 3.50 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Vividness of Image | 6 hours | 2.58 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Vividness of Image | 1 hour | 4.24 score on a scale |
| Harmine Hydrochloride 300mg | Visual Analog Scale (VAS) - Vividness of Image | 24 hours | 2.20 score on a scale |