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.

Target Enrollment
27 participants
Study Type
Phase I interventional
Design
Randomized

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

  • 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

Locations

Unknown facility — Australia

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