Medically Supervised Ibogaine With 12-Month Digital Recovery Support for Opioid Use Disorder

You may not qualify if:

• Congenital or acquired long-QT syndrome.
• Fridericia-corrected QT interval greater than 450 milliseconds for males or greater than 470 milliseconds for females on a protocol-qualifying screening or pre-dose electrocardiogram, or a stricter threshold required by the FDA-authorised protocol.
• History or current evidence of clinically important cardiac disease that could materially increase arrhythmia or haemodynamic risk, including: Torsade de pointes; Ventricular tachycardia or ventricular fibrillation; Previous sudden cardiac arrest; Clinically significant conduction disease; Brugada syndrome; Unexplained cardiac syncope; Cardiomyopathy; Significant heart failure; Significant valvular disease; Active myocarditis or pericarditis; Active or inadequately treated infective endocarditis; Unstable coronary disease; Recent myocardial infarction; Clinically significant atrial or ventricular arrhythmia.
• Family history suggesting an inherited arrhythmia syndrome or unexplained premature sudden cardiac death, unless specialist assessment establishes acceptable risk under the protocol.
• Clinically significant bradycardia, tachycardia, uncontrolled hypertension, symptomatic hypotension, or autonomic instability that has not been corrected before treatment.
• Uncorrected hypokalaemia, hypomagnesaemia, hypocalcaemia, or another clinically significant electrolyte or acid-base abnormality.
• Clinically significant hepatic impairment, decompensated liver disease, acute hepatitis, impaired hepatic synthetic function, or laboratory abnormalities expected to alter ibogaine or noribogaine exposure materially.
• Clinically significant renal impairment or unstable renal disease.
• Unstable respiratory, neurological, endocrine, gastrointestinal, haematological, infectious, or other systemic disease that could increase the risk of treatment, aspiration, arrhythmia, vomiting, immobility, or emergency intervention.
• Current sepsis, uncontrolled systemic infection, active infective endocarditis, or another infection requiring urgent treatment.
• Current pregnancy, intended pregnancy during the protocol-defined risk period, or breastfeeding.
• Known hypersensitivity or previous serious adverse reaction to ibogaine, noribogaine, another iboga alkaloid, or an investigational-product excipient.
• Previous ibogaine exposure associated with clinically significant QT prolongation, arrhythmia, syncope, seizure, mania, psychosis, cardiac arrest, or another serious adverse event.
• Use of a medication, supplement, or substance that creates unacceptable risk through one or more of the following: QT prolongation or torsade de pointes; Bradycardia or conduction disturbance; Clinically significant cytochrome P450 2D6 inhibition or induction; Serotonergic toxicity; Reduction of the seizure threshold; Excessive sedation or respiratory depression; Hemodynamic instability.
• Inability to discontinue, substitute, or medically transition from a prohibited medication within a pharmacologically justified period. A medically necessary treatment will not be stopped solely to qualify for enrolment where discontinuation would create greater risk.
• +16 more criteria