A Study of Oral Ibogaine in Opioid Withdrawal

Exclusion Criteria

• •Current diagnosis of opioid or other substance dependence (except caffeine) according to DSM-IV or DSM-5 definitions (Stage 1 only).
• •Any history of seizure or convulsion, including febrile convulsion in childhood or as an adult.
• •History of chronic or frequent migraines.
• •Current or recent (≤1 year) history of significant alcohol abuse (\>3 units per day on a regular basis)
• •For Stage 1, drug dependency disorder.
• •For Stage 2, polydrug abuse or dependency within the past 3 years other than opioids, caffeine, and/or nicotine.
• •Personal history or presence of primary psychotic disorder (including substance-induced or due to a medical condition), bipolar affective disorder Type I or Type II, or schizophrenia (not including non-psychotic, clinically stable disorders such as depression or anxiety).
• •First or second-degree family history of primary psychotic disorder, bipolar affective disorder Type I or Type II, or schizophrenia.
• •Showing suicidal tendency as per the Columbia Suicide Severity Rating Scale (C-SSRS).
• •Any prior use of ibogaine, noribogaine or other chemically related substances or any allergy or intolerance to excipients in the ibogaine capsules.
• •History or presence of clinically significant cardiovascular disease including angina, myocardial infarction, coronary artery disease, heart failure, arrhythmias, endocarditis, syncope of unknown origin, or any other condition that, in the opinion of the investigator, may be associated with a higher risk of arrhythmias.
• •History or presence at screening (12-lead ECG and 24-hour Holter monitoring) or Day -2 (12-lead ECG) of ECGs that (1) shows QTcF interval duration \>420 ms (if QTcF \>420 ms prior to dosing on Day 1, subjects need not be excluded provided QTcF was ≤ 420 at Screening and Day -2 and QTcF ≤ 440 on Day 1.), PR interval duration \>210 ms, or QRS interval duration \>120 ms, obtained as an average from 3 ECG recordings, taken at least 1 minute apart after at least 10 minutes of quiet rest in the supine position; or (2) ECG showing ventricular bigeminy, trigeminy or couplets; or (3) shows, in the opinion of the investigator, any other clinically significant abnormality.
• •History or family history of prolonged QT interval cardiac channelopathy or sudden cardiac death.
• •Orthostatic hypotension or uncontrolled hypertension as characterized by sustained systolic elevation to ≥160 mmHg and/or diastolic elevation to ≥100 mmHg at screening or Day -2.
• •Subjects with an average resting heart rate of \<50 bpm on the ECG at screening.
• •Use of any prescription drugs in the 28 days prior to the first study drug administration, that are known to inhibit or induce CYP2D6 or to cause QT prolongation or, in the opinion of the investigator, would put into question the status of the participant as healthy.