A20 PARTICIPANTS
Established comparator
Extended-release naltrexone provides an active comparator in the randomized portion of the proposed study.
The clinical study
A rigorous study.
A more informed future.
The proposed IBOCare Phase 1/2a study brings medically supervised ibogaine research together with a year of continuing recovery support.
The public study record
ClinicalTrials.gov · NCT07871877
Medically Supervised Ibogaine With 12-Month Digital Recovery Support for Opioid Use Disorder
The IBO-CARE registration sets out the planned study design, eligibility criteria, outcome measures and recruitment status.
Read the study registrationWhy this study
Promise deserves
proper evidence.
Early observations raise important questions. Careful research is how we find reliable answers.
Published observational research has reported changes in opioid withdrawal and craving after ibogaine. These studies do not establish long-term effectiveness or prove that ibogaine caused the outcomes.
Research has also documented important cardiac risks, including QT interval prolongation. Those risks make specialist screening, monitoring and independent oversight essential to the proposed study.
Read the original studies: withdrawal and craving (2018) · cardiac safety (2021).
The proposed design
Three groups.
One standard of care.
60 planned participants, ages 18–65.
One proposed Colorado clinical site.
C20 PARTICIPANTS
Randomized ibogaine
Compared with Group A in a proposed double-blind, double-dummy design to support a fair comparison.
B20 PARTICIPANTS
Recent-use pathway
A separate proposed pathway for people unable to complete a longer opioid-free waiting period.
Everyone receives the same planned preparation, monitored admissions, psychological support, monthly visits and 12 months of digital recovery support.
Design summary from the foundation’s donor briefing. The protocol may change through regulatory and ethics review.
Safety is the design
Careful by intention.
At every step.
Participant safety informs screening, monitoring, oversight and decisions about continuing.
Specialist screening
Cardiology review, laboratory tests and exclusion criteria for people at elevated cardiac risk.
72-hour cardiac monitoring
The proposed plan includes continuous telemetry and serial ECGs after each dose, extended when needed.
Independent oversight
A proposed five-member safety board with a cardiologist chair and an independent medical monitor.
Clear stopping rules
Predefined cardiac and clinical thresholds to pause dosing for an individual or a study group.
The participant journey
One year.
Support that stays.
Explore the proposed journey, from initial screening to a full year of follow-up.
Before enrollment
A careful beginning.
Medical, cardiac and psychiatric evaluation, followed by informed consent. The study team will determine eligibility. Participants are prepared for the planned admissions and issued study devices.
Screening is an assessment, not a guarantee of enrollment.
Months 0, 1 and 2
Care in a monitored setting.
The proposed protocol includes three clinical admissions. Each later session proceeds only after a safety review. Cardiac monitoring continues for at least 72 hours after dosing and longer when needed.
Safety findings guide every decision about further dosing.
Through month 3
Making space for the next step.
Weekly online psychological support is planned through the first three months, alongside the study’s other care and safety measures.
Participants receive overdose education, naloxone and access to standard treatment.
Through month 12
A bridge into everyday life.
SENTINEL combines daily wellbeing check-ins, a study phone and wearable, and monthly clinic visits. Alerts go to a named clinician; technology does not make care decisions alone.
My E Health is the proposed platform behind digital support and data services.
From readiness to results
Funding starts
the work ahead.
The donor briefing models a 39-month programme. These are planned phases, not announced treatment dates.
- MONTHS 1–9
Readiness
Regulatory and ethics review, required permissions and site preparation.
- MONTHS 10–12
First sessions
Carefully sequenced first doses and safety-board review.
- MONTHS 13–26
Enroll & study
Planned enrollment and treatment with interim safety review.
- MONTHS 25–36
Follow-up
A full year of care and follow-up data for every participant.
- MONTHS 37–39
Share the findings
Analysis, publication and recommendations for next steps.
Read the evidence
Open questions.
Original sources.
2018 · OBSERVATIONAL STUDY
Changes in withdrawal and craving scores
A 50-participant study that supports further controlled investigation.
2021 · SAFETY STUDYCardiac and neurological safety observations
An open-label study reporting QTc prolongation and other adverse effects.
2024 · PHARMACOLOGYIbogaine pharmacokinetics and pharmacodynamics
An investigation of drug exposure, metabolism and safety effects.
These are independent published studies, not results from IBOCare. The IBO-CARE trial registration is linked above; no study results are posted in that record.
Hope, with a way forward
Better questions.
Better-informed care.
Help make responsible, transparent clinical research possible.