Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05029401 | A Study of Oral Ibogaine in Opioid Withdrawal | PHASE1 | COMPLETED | 116 | — | — | Apr 1, 2021 | Jan 16, 2024 | Aug 6, 2024 | 2 | United Kingdom |
The SOWS-Gossop is a 10-item questionnaire to evaluate opioid withdrawal symptom severity. Each item is scored on a 4-point scale. Higher scores indicate greater severity (total score range 0-40).
| Arm | Type | Description |
|---|---|---|
| Single dose IMP (DMX-1002) | EXPERIMENTAL | Stage 1 (single blind, placebo controlled): initial dose of placebo, followed by treatment at one of 4 ascending dose levels of IMP (3, 6, 9 or 12 mg/kg) Stage 2 (blinded): MTD/TTD established in Stage 1 vs placebo (proof of concept) |
| Matching Placebo | PLACEBO_COMPARATOR | Placebo using capsules identical to the IMP (DMX-1002) |
| Name | Type | Description |
|---|---|---|
| DMX-1002 | DRUG | Investigation of the safety, tolerability and pharmacokinetics (PK) in healthy volunteers (Stage 1 - single blind), and the efficacy, safety, tolerability and PK in opioid-dependent patients (Stage 2 - double blind) |
| Placebo | DRUG | Matching placebo to the IMP (DMX-1002) |
Important Inclusion Criteria for both Stages 1 and 2: * Males and females between 18 years and 55 years of age. * For Stage 1, healthy volunteers; recreational opioid use is allowed but not required for inclusion in the study. * For Stage 2, opioid-dependent subjects (DSM-IV) seeking medically supe...