An open label study to evaluate the safety, tolerability, and subjective effects of two dimethyltryptamine (DMT) and harmala alkaloid containing formulations in healthy volunteers

Exclusion Criteria17

• History of psychosis: past or present diagnosis of bipolar disorder, schizophrenia, or schizoaffective disorder.
• Family history of psychosis: past or present diagnosis of bipolar disorder type 1 in first degree relative, or schizophrenia, or schizoaffective disorder in first or second degree relative.
• Current suicidality or history of suicide attempt.
• Current psychiatric disorder diagnosis.
• Daily/weekly high-risk alcohol use (as per NHMRC guidelines).
• Use of any psychoactive medication (e.g., a selective serotonin reuptake inhibitor such as paroxetine or citalopram), haloperidol, any medication with MAO activity (such as isocarboxazid, phenelzine, selegiline or tranylcypromine, linezolid, and methylene blue), or any drug that has been indicated as a potential precipitative agent for serotonin syndrome within 28 days prior to study drug administration and through to the end of study.
• Currently taking any other regular medication, including: Opiates, Anti-histamines, Anti-convulsants, Amphetamines, Kava, and St John’s wort.
• Used a hallucinogen in the past month (a one-month wash-out is acceptable)
• Smoking/using nicotine
• Substance/alcohol use disorder
• History of Hallucinogen Persisting Perception Disorder (HPPD).
• Serious medical condition e.g., Cardiovascular, Metabolic, Neurological, Respiratory, Oncological, haematological disorder.
• Serious ECG abnormality
• Serious abnormal haematology or electrolyte, renal or liver test result (indicated by screening aspartate aminotransferase (AST) or alanine aminotransferase (ALT) 1.2X or total bilirubin 1.5 x upper limit of normal (ULN), which remains above these limits if retested) in the previous 12 months (as provided by their GP or SVHM).
• Not agreeing to fasting from midnight prior to the Dose Day sessions until the afternoon of that treatment day.
• Females who are pregnant, nursing, or trying to become pregnant (pregnancy test provided).
• Participation in another clinical study involving investigational study treatment within 30 days or 5 half-lives, whichever is longer, prior to screening.