Study record at a glance
| Study ID | NCT04003948 |
|---|---|
| Design | Completed Phase 2 randomized, parallel-group, double-blind study; the registry additionally specifies quadruple masking of participants, care providers, investigators, and outcomes assessors |
| Condition / topic | Opioid dependence and methadone detoxification |
| Population | Participants with opioid dependence receiving methadone treatment, studied at a single hospital site in Catalonia, Spain |
| Sample size | 20 participants, actual enrollment |
| Comparator | Fixed-dose and ascending-dose ibogaine hydrochloride arms; no placebo arm is listed in the registry |
| Follow-up | Methadone dose was registered over 0 to 6 months; adverse events and cardiovascular measures were registered over 0 to 24 hours |
| Outcome focus | Rate of methadone dose decrease, adverse events at different doses, and electrocardiogram measures including QT interval and ST wave |
What it suggests
The registry documents completion of a small, masked, randomized dose-comparison study with defined methadone-taper and safety outcomes under hospital monitoring
What it cannot establish
Registry completion does not establish efficacy, comparative benefit, or long-term safety. This Atlas draws no efficacy conclusion without a results source, and the small single-site dose-comparison design limits generalization
Recruitment relevance
The registry lists the trial as completed, with primary completion in April 2024. It is not open for enrollment
Do not travel, discontinue medication, or change care based on this summary. The sponsor and the current primary source govern participation decisions.
How this summary was framed
This record reports the design and registered or officially announced research question before interpretation. Unknown sample, comparator, follow-up, and outcome details remain marked as unknown. The Atlas does not infer results from recruitment status, regulatory acceptance, funding, or study completion.