Clive Michelsen
IBO-CARE is a single-site Phase 1/2a study evaluating the safety, tolerability, feasibility and preliminary outcomes of medically supervised ibogaine with 12 months of recovery support in adults with moderate-to-severe opioid use disorder. Up to 120 candidates will be screened to enrol 60 adults aged 18-65 into three cohorts of 20. Participants meeting the shared opioid-free and negative naloxone-challenge criteria will be randomised 1:1 to Cohort A or Cohort C. Cohort A receives extended-release naltrexone 380 mg intramuscularly and matching oral placebo. Cohort C receives oral ibogaine hydrochloride and matching intramuscular placebo. Cohort B follows a separate, nonrandomised recent-use ibogaine pathway with matching intramuscular placebo and clinically supervised stabilisation. All cohorts attend three monitored oral-treatment admissions at Months 0, 1 and 2. Repeat ibogaine administrations require individual eligibility and safety release. The planned injection schedule comprises twelve calendar-monthly administrations at Months 0-11, with final follow-up at Month 12. All participants receive equivalent preparation, psychological support, continuing addiction care, monthly clinical review and SENTINEL digital recovery support with a Garmin Venu 4. The acute monitoring model includes continuous telemetry during a 72-hour post-dose window, serial 12-lead ECGs, laboratory monitoring, emergency capability and independent safety oversight. Monitoring is extended when clinically required. Wearable information does not replace clinical cardiac monitoring. SENTINEL combines participant reports, wearable trends and scheduled assessments, with high-risk findings reviewed by qualified clinicians. Cohorts A and C use a double-blind, double-dummy comparison. Cohort B is open to the treating team, with masked outcome assessment where feasible. Treatment guesses are collected because the acute effects of ibogaine may reveal allocation. The study estimates preliminary effects and is not designed to establish confirmatory efficacy. The IND application has not yet been filed. The study remains not yet recruiting. ClinicalTrials.gov registration and assignment of an NCT number do not authorise study conduct. Enrolment and investigational treatment will begin only after the IND is in effect, IRB approval is in place, and all applicable DEA, Colorado, investigational-product, clinical-site and digital-system requirements have been satisfied. The registration will be updated when the actual FDA filing details are available.
1 Purpose and design This funding- and authorisation-dependent study has three parallel cohorts. A and C constitute the randomised comparison of XR-naltrexone and ibogaine using matching oral and intramuscular placebos. B is a separate recent-use cohort and is analysed separately. The study evaluates acute safety, cardiac effects, eligible acute-withdrawal outcomes, feasibility and preliminary recovery outcomes during equivalent 12-month support. It does not include a placebo-only cohort deprived of continuing addiction care. 5 Study Description continued 2 Screening and baseline Potential p…
Inclusion Criteria 1. Adult aged 18 to 65 years, inclusive. 2. Meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision criteria for moderate or severe opioid use disorder, confirmed by a structured diagnostic assessment conducted by a qualified clinician. 3. Has current physiological opioid dependence, current non-prescribed use, current opioid agonist treatment requiring an approved transition, or a documented recent history of moderate or severe opioid use disorder followed by supervised withdrawal. Participants entering A/C after at least 30 opioid-free da…
Pharmaceutical-quality ibogaine hydrochloride administered orally during monitored admissions at Months 0, 1 and 2 in Cohorts B and C. The formulation, strength, weight-capped dose ceiling, interaction controls, pharmacokinetic schedule, repeat-dose release criteria, residual-noribogaine criteria and stopping rules require approval in the controlled protocol and Investigator's Brochure. Each administration requires a documented eligibility and safety review. Arm Associations: B and C
Extended-release naltrexone 380 mg administered intramuscularly to Cohort A after the approved opioid-free interval, negative naloxone challenge and other clinical eligibility checks. The shared planning schedule is twelve calendar-monthly injections at Months 0-11. Exact timing, first-injection date, subsequent eligibility and missed-dose rules require D5 confirmation. Arm Associations: A
Matching oral placebo administered during the three monitored admissions at Months 0, 1 and 2 in Cohort A to maintain the double-dummy comparison. Composition, matching, manufacture, accountability and release follow the approved product documentation. Arm Associations: A
Matching intramuscular placebo administered every four weeks for 12 months.
SENTINEL is a study-provided digital monitoring and clinician-support platform used by all cohorts during baseline monitoring and 12-month follow-up. It combines daily participant reports, Garmin-derived longitudinal wellness data, scheduled psychometric assessments, adherence information, trend visualisation and protocol-defined risk-state classification. Orange, Red and Urgent states route to a named qualified clinician or emergency service under the escalation SOP. SENTINEL does not autonomously diagnose, prescribe, change medication or determine emergency treatment. It does not replace continuous telemetry, clinically interpreted 12-lead ECGs, toxicology, bedside examination or emergency assessment. Remote routines pause during scheduled acute admissions while clinical monitoring continues. Arm Associations: A, B and C
All cohorts receive standardised psychological preparation, supportive care during monitored admissions, post-treatment integration, weekly online support through Month 3, relapse-prevention planning, overdose-prevention education, continuing-care coordination and monthly face-to-face clinical support through Month 12. Support intensity is equivalent across cohorts. Rescue care, access to evidence-based addiction treatment and individual clinical needs take priority over preserving study allocation. Arm Associations: A, B and C
All cohorts receive a Garmin Venu 4 with a study-provided Apple phone, training and connectivity. Protocol-specified wellness information includes sleep, resting heart rate, overnight heart-rate variability, respiration, overnight oxygen-saturation estimates, steps, activity, all-day stress and Body Battery. Data support exploratory longitudinal trends in SENTINEL. The wearable is not used to measure QTc, diagnose arrhythmia or replace telemetry, 12-lead ECGs or clinical assessment. Valid-day and baseline rules and scheduled acute-admission pauses are defined in the data plan. Arm Associations: A, B and C