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
- 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.