A Phase 1B, Single Center, Randomized, Double-Blind, Placebo-Controlled, Ascending Single Dose Study of the Safety, Tolerability and Pharmacokinetics of Noribogaine in Opioid-Dependent Patients Discontinuing Methadone

Ascending single-dose, double-blind, placebo-controlled safety study of noribogaine in opioid-dependent patients

In a randomized, double‑blind, placebo‑controlled single ascending‑dose study in 27 opioid‑dependent patients, noribogaine was generally well tolerated with dose‑linear pharmacokinetics (t1/2 24–30 h) but caused a concentration‑dependent QTcI prolongation (mean increases ≈16, 28 and 42 ms at 60, 120 and 180 mg) and mostly mild adverse events (visual changes, headache, nausea). There was a non‑significant trend to reduced opioid withdrawal scores, most apparent at 120 mg, but study design limits efficacy conclusions and supports planned exposure‑controlled multiple‑dose trials.

Published

April 1, 2016

Journal

Clinical Pharmacology in Drug Development

Authors

Glue, P., Cape, G., Tunnicliff, D., Lockhart, M., Lam, F., Hung, N., Tak Hung, C., Harland, S., Devane, J., Crockett, R. S., Howes, J., Darpo, B., Zhou, M., Weis, H., Friedhoff, L., Buckland, H.