Ascending Single-Dose, Double-Blind, Placebo-Controlled Safety Study of Noribogaine in Opioid-Dependent Patients.
Clinical pharmacology in drug development November 1, 2016 Paul Glue, Gavin Cape, Donna Tunnicliff et al. 66 citations
Noribogaine, the active metabolite of ibogaine, was tested for the first time in patients on methadone opioid substitution therapy. In a randomized, double-blind, placebo-controlled trial with 27 patients, doses of 60, 120, or 180 mg were well tolerated, with common side effects including temporary changes in light perception, headache, and nausea. The drug showed dose-linear increases in blood concentration and a slow elimination half-life of 24–30 hours. Noribogaine caused a concentration-dependent increase in heart rate–corrected QT interval (QTcI), with average increases of about 16, 28, and 42 milliseconds at the three doses. There was a nonstatistically significant trend toward reduced opioid withdrawal symptoms, most notably at 120 mg, but study design issues may have affected results.