Clinical TrialIbogaineIbogaineIbogainePlaceboCompleted

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

Phase 1B single-center randomized double-blind placebo-controlled ascending single-dose safety/PK study of noribogaine (60, 120, 180 mg oral) in methadone-maintained opioid-dependent adults. Enrollment: 27. Primary outcomes: Cmax, half-life, Tmax, clearance, plus safety via AEs, vitals, ECG and psychological assessments through Day 7. Sponsor: DemeRx Inc. Single center, New Zealand.

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Target Enrollment
27 participants
Study Type
Phase I interventional
Design
Randomized, double Blind

Study Arms & Interventions

Noribogaine 60mg

experimental

Single dose of 60 mg noribogaine administered orally

Interventions

  • Ibogaine60 mg
    via Oral• single dose• 1 doses total

    Administered with 240 mL of water

Noribogaine 120mg

experimental

Single dose of 120 mg noribogaine administered orally

Interventions

  • Ibogaine120 mg
    via Oral• single dose• 1 doses total

    Administered with 240 mL of water

Noribogaine 180mg

experimental

Single dose of 180 mg noribogaine administered orally

Interventions

  • Ibogaine180 mg
    via Oral• single dose• 1 doses total

    Administered with 240 mL of water

Placebo

placebo

Matching oral placebo

Interventions

  • Placebo
    via oral• single dose• 1 doses total

    Matching placebo administered with 240 mL of water

Study Protocol, Arms & Participants

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Study Details

  • Status
    Completed
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Randomizeddouble Blind
  • Target Enrollment27 participants
  • Timeline
    Start: 2013-10-14
  • Compounds
    IbogaineIbogaineIbogainePlacebo

Related Publications

PaywallindividualPrimary

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
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.

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