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)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613001064796

Acronym

NITROW-P1

Enrollment

Registered

2013-09-24

Start date

2013-10-14

Completion date

2014-05-13

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 under supervision at the study site.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

The main inclusion criteria are opioid dependent male and female adults who provide written consent and are on stable doses of methadone through the OST programme. Participants cannot have any other major illnesses or disorders and must be willing to comply with the restrictions of the study.

Exclusion criteria

Exclusion criteria include current treatment for hepatitis C; HIV positive; DSM IV Axis I diagnosis of psychotic disorders; specified excluded concomitant medications; DSM IV criteria for dependence on substances other than opioids, caffeine, and/or nicotine.

Outcome results