CompletedPhase 1ACTRN12613001064796

Noribogaine Therapy for Relief of Opioid withdrawal, Phase 1B

A Phase 1B, Single Center, Randomized, Double-Blind, Placebo-Controlled, Ascending Single Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Noribogaine in Opioid Dependent Participants Seeking to Discontinue Methadone Opioid Substitution Treatment (OST)


Sponsor

DemeRx Inc

Enrollment

27 participants

Start Date

Oct 14, 2013

Study Type

Interventional

Conditions

Summary

This is a research study to evaluate the safety, tolerability and effects of noribogaine, an atypical opioid. We will also be looking at its effects on opioid withdrawal symptoms in opioid dependent people who are maintained on stable doses of methadone and who want to stop taking methadone.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

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Interventions

Administration of a single oral dose of noribogaine. It is planned that the first dose cohort will receive 60mg, the second cohort 120mg and the third cohort 180mg. Noribogaine will be administered un

Administration of a single oral dose of noribogaine. It is planned that the first dose cohort will receive 60mg, the second cohort 120mg and the third cohort 180mg. Noribogaine will be administered under supervision at the study site.


Locations(1)

Otago, New Zealand

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ACTRN12613001064796