oribogaine Therapy for Relief of Opioid withdrawal, Phase 1B
Phase 1
Completed
- Conditions
- Symptoms of opioid withdrawalMental Health - Addiction
- Registration Number
- ACTRN12613001064796
- Lead Sponsor
- DemeRx Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 27
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 & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Evaluate the safety and tolerability of noribogaine in opioid dependent participants seeking to discontinue their methadone OST. This will be evaluated by adverse events, vitals signs, ECGs, laboratory tests, physical exam, ocular exam and C-SSRS.[Day 7];Evaluate the pharmacokinetics of noribogaine in opioid dependent participants seeking to discontinue their methadone OST. The following pharmacokinetic parameters will be derived for noribogaine: Cmax, AUCT, AUC0-inf8), half-life, Tmax, Vd/F and CL/F. Urine will be assayed for noribogaine and its metabolites.[Day 7]
- Secondary Outcome Measures
Name Time Method oribogaine and methadone pharmacodynamics, as measured by oximetry, capnography and pupillometry[Day 7];Methadone Pharmacokinetic Analysis - the following pharmacokinetic parameters will be derived for methadone: Cmax, AUCO24, AUC, AUC0 inf, and half-life, Tmax, Vd/F and CL/F. [Day 1];Ability to discontinue methadone OST (Endpoint is time to resumption of OST)[Day 7];Withdrawal Suppression as measured by SOWS, OOWS, COWS, Mood VAS, ASI and PRS rating scales[Day 7]