A Phase 1B, Single Center, Randomized, Double-Blind, Placebo-Controlled, Ascending Single Dose Study of the Safety, Tolerability and Pharmacokinetics of Noribogaine in Opioid-Dependent Patients Discontinuing Methadone
Phase 1B single-center randomized double-blind placebo-controlled ascending single-dose safety/PK study of noribogaine (60, 120, 180 mg oral) in methadone-maintained opioid-dependent adults. Enrollment: 27. Primary outcomes: Cmax, half-life, Tmax, clearance, plus safety via AEs, vitals, ECG and psychological assessments through Day 7. Sponsor: DemeRx Inc. Single center, New Zealand.
Study Arms & Interventions
Noribogaine 60mg
experimentalSingle dose of 60 mg noribogaine administered orally
Interventions
- Ibogaine60 mgvia oral• single dose• 1 doses total
Administered with 240 mL of water
Noribogaine 120mg
experimentalSingle dose of 120 mg noribogaine administered orally
Interventions
- Ibogaine120 mgvia oral• single dose• 1 doses total
Administered with 240 mL of water
Noribogaine 180mg
experimentalSingle dose of 180 mg noribogaine administered orally
Interventions
- Ibogaine180 mgvia oral• single dose• 1 doses total
Administered with 240 mL of water
Placebo
placeboMatching oral placebo
Interventions
- Placebovia oral• single dose• 1 doses total
Matching placebo administered with 240 mL of water
Primary Results(1 publication)
Participants
Adverse Events (from all publications)
| Arm / Group | n | Any TEAE | Severe | Serious | Discont. |
|---|---|---|---|---|---|
| Noribogaine 60mgexperimental | 6 | — | 0(0.0%) | 0(0.0%) | — |
| Noribogaine 120mgexperimental | 6 | — | 0(0.0%) | 0(0.0%) | — |
| Noribogaine 180mgexperimental | 6 | — | 0(0.0%) | 0(0.0%) | — |
| Placeboplacebo | 9 | — | 0(0.0%) | 0(0.0%) | — |
* Three AEs were rated as severe (nausea, vomiting, and headache) across all participants; specific arm counts for severe AEs not provided in summary table. Table 3 shows 0 severe AEs for 60mg arm specifically for the listed common AEs.
* Three AEs were rated as severe (nausea, vomiting, and headache) across all participants; specific arm counts for severe AEs not provided in summary table. Table 3 shows 0 severe AEs for 120mg arm specifically for the listed common AEs.
* Three AEs were rated as severe (nausea, vomiting, and headache) across all participants; specific arm counts for severe AEs not provided in summary table. Table 3 shows 0 severe AEs for 180mg arm specifically for the listed common AEs.
* Three AEs were rated as severe (nausea, vomiting, and headache) across all participants; specific arm counts for severe AEs not provided in summary table. Table 3 shows 1 severe AE (nausea) for placebo arm specifically for the listed common AEs.