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Mash DC, Allen-Ferdinand K, Mayor M, Kovera CA, Ayafor JF, Williams IC, Ervin FR.
“[Ibogaine:] Clinical Observations of Safety after Single Oral Dose Administration”.
College on Problems of Drug Dependence (CPDD). 1998 June.
Ibogaine, a naturally occurring indole alkaloid derived from the roots of Tabernanthe iboga, is currently under investigation as a therapeutic agent for drug dependence. We report here preliminary observations on the safety of single oral dose administration of ibogaine to cocaine and heroin dependent subjects. Baseline screening included a medical evaluation, physical examination, ECG, blood chemistries, and hematological work-up, as well as psychiatric and chemical dependency evaluations. Subjects (N=30) were assigned to one of three fixed-dose treatments under open label conditions: 500 mg, 600 mg, and 800 mg ibogaine. Adverse events were assessed by clinical side-effects ratings and open-ended query. No significant adverse events were seen under these study conditions. The most frequent side effects were nausea and mild tremor at early time points after drug administration. Random regression of vital signs (respiration rate, systolic and diastolic blood pressures and pulse) revealed no significant changes across time or by treatment condition. White blood count, neutrophil levels, sodium or potassium levels were in the normal range. No significant changes from baseline were seen for ALT, AST, alkaline phosphatase (ALP), and GGT. Intensive monitoring demonstrated that no electrocardiographic abnormalities were produced or exaggerated following ibogaine administration. These preliminary results demonstrate that single doses of ibogaine were well tolerated in drug-dependent subjects, and that there were no significant problems with safety. Supported in part by the Addiction Research Fund.
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