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
- Journal
- Clinical Pharmacology in Drug Development
- Authors
- Cape, G., Crockett, R. S., Darpo, B., Devane, J., Friedhoff, L., Glue, P., Harland, S., Howes, J. F., Hung, C. T., Hung, N., Lam, F., Lockhart, M., Tunnicliff, D., Weis, H., Zhou, M.