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Noribogaine Therapy for Relief of Opioid... — Clinical Trial Details | Blossom

Clinical TrialIbogaineCompleted

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)

This randomised controlled parallel group Phase I trial (n=27) evaluated the safety and efficacy of noribogaine for symptoms of opioid withdrawal.

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Target Enrollment

27 participants

Study Type

Phase I interventional

Design

Randomized

Registry

ANZCTR / ACTRN12612000821897

Detailed Description

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.

Study Arms & Interventions

Experimental Arm

experimental

Interventions

Ibogaine

Participants

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

Locations

Unknown facility — Australia

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.

Study Details

Status
Completed
Phase
Phase I
Type
interventional
Design
Randomized
Target Enrollment27 participants
Timeline
Start: 2013-10-14
End: 2014-05-13
Compound
Ibogaine