A Phase 1/2 interventional study of Ibogaine Hydrochloride and Extended-release naltrexone injection, 380 mg in Opioid Use Disorder, Opioid Withdrawal and Substance Use Disorders, sponsored by Clive Michelsen. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Clive Michelsen · Phase 1/2, Interventional, and Treatment
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 participants undergo confirmation of DSM-5-TR moderate or severe opioid use disorder, consent capacity, treatment need and cohort eligibility. Screening includes medical and psychiatric history, physical and neurological examination, suicide and self-harm assessment, medicine and supplement reconciliation, recent-substance assessment, safety laboratory tests, pregnancy testing where applicable and specialist cardiovascular evaluation. Cardiac screening includes qualifying 12-lead ECGs, electrolytes and personal and family arrhythmia history, with further investigations where indicated.
The study provides a Garmin Venu 4, an Apple phone, training, connectivity and accessibility support. A 14-28-day digital baseline is sought where feasible without delaying clinically necessary care; shorter baselines and reasons are recorded. Baseline digital information includes participant-reported mood, craving, withdrawal, sleep, adherence and engagement, together with wearable-derived longitudinal wellness measures. Interpretation emphasises change within the participant. Minimum evaluable baseline coverage is specified in the data plan.
3 Cohort assignment and treatment transition Participants entering A/C complete the approved opioid-free interval and negative naloxone challenge before randomisation and assigned treatment. Randomisation is 1:1; the proposed opioid-free strata of 7-29 versus at least 30 days require confirmation. The safe interval depends on the opioid, treatment history and specialist assessment; the strata do not replace eligibility requirements.
Cohort B uses the approved recent-use pathway without a universal 30-day abstinence requirement. The planning model permits up to 48 hours of first-admission stabilisation. Current methadone treatment does not permit direct entry to B. Previous methadone or buprenorphine exposure is not a lifetime exclusion, but a protocol-approved specialist transition must be completed before dosing. Abrupt or unsupervised discontinuation of effective treatment is not required to enter the trial.
4 Monitored treatment admissions Three oral-treatment sessions occur at Months 0, 1 and 2. A receives matching oral placebo and B/C receive pharmaceutical-quality ibogaine hydrochloride. Formulation, dose, weight cap, timing, prohibited medicines, interaction controls, residual-noribogaine criteria and repeat-dose release conditions require final clinical and regulatory agreement. No numerical ibogaine dose is specified by this registration consolidation.
All cohorts receive equivalent clinical observation and supportive care. The shared planning model retains continuous telemetry for the 72-hour post-dose window, serial clinically interpreted 12-lead ECGs, vital signs, safety laboratory testing and pharmacokinetic sampling where applicable. Monitoring continues beyond the scheduled window when clinically required. Resuscitation capability, cardiology and emergency support, and a documented transfer pathway must be operational before site activation.
The protocol monitors cardiovascular, neurological and psychiatric adverse events, including dehydration, vomiting, aspiration, ataxia, falls, seizures, agitation, mania, psychosis and suicidality. Clinically relevant abnormalities require assessment and correction. QTcF of at least 500 ms or an increase of at least 60 ms enters the proposed stopping pathway; the confirmed measurement, action and cohort-pause rules must appear in the controlled clinical protocol. Consumer wearables are not used to measure QTc or to replace telemetry or 12-lead ECGs.
5 Study Description continued
5 Continuing care and injections The planned schedule comprises twelve calendar-monthly IM injections at Months 0-11: XR-naltrexone 380 mg in A and matching placebo in B/C. The first three injections occur during the corresponding monitored admissions when medically appropriate. The first-injection reference date, exact visit windows, eligibility, missed-dose management and rescue rules require D5 confirmation. No study injection is scheduled at Month 12.
All cohorts attend monthly clinical visits through Month 12 for review, ECG, protocol-defined laboratory testing, toxicology, recovery planning and face-to-face support. Naloxone challenge is performed only when required by the approved A/C pathway and clinical circumstances; it is not automatically repeated at every monthly visit. Weekly online integration continues through Month 3, with continuing clinical support throughout follow-up.
Before discharge, participants receive an individual continuing-care and overdose-prevention plan, naloxone access and education, information about reduced opioid tolerance, rapid access to opioid agonist treatment when indicated or requested, psychiatric and addiction referrals, emergency contacts and relevant social support. Rescue care and transition to ordinary treatment are not withheld to preserve study allocation. Follow-up continues after treatment discontinuation when consent permits.
6 Digital support and participant assessments Daily participant check-ins and Garmin-derived wellness data feed SENTINEL outside scheduled acute-admission pauses. Clinical monitoring continues during these pauses. PHQ-9 and GAD-7 are collected weekly through Month 12. EFP Mini, PCL-5 and the selected quality-of-life instrument are collected monthly, with registered change analyses at Months 1, 3, 6 and 12. SOWS and OOWS follow the acute schedule and are collected weekly through Month 3, then monthly during Months 4-12. Craving measurement and all instrument-specific rules require the decisions identified in Appendix C.
The five-state model comprises Green, Yellow, Orange, Red and Urgent. Orange requires same-day qualified clinical review; Red requires immediate live contact and urgent evaluation; Urgent directs immediate emergency action. Exact operational response windows, staffing, backup and coverage require the approved escalation SOP. Medical emergencies are directed to 911; 988 may support suicide or crisis needs without delaying emergency response. Students may support Green/Yellow activities under supervision and must not independently close Orange or higher events. SENTINEL does not autonomously diagnose, prescribe or change medication.
7 Trial data and regulatory status The validated study electronic data capture system remains the trial data system of record. Source records, ECGs, laboratory results, adverse events, protocol deviations and investigational-product accountability remain within the sponsor-approved architecture. SENTINEL supplies governed data transfers, audit trails, recorded human actions and longitudinal support. The study will report results by cohort, account for missingness and rescue treatment, and avoid treating the nonrandomised B cohort as part of the randomised A/C comparison.
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.
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Cohort Specific Entry Criteria
Exclusion Criteria
Twenty participants meeting the protocol-approved opioid-free and negative naloxone-challenge criteria are randomised 1:1 against Cohort C. Participants attend monitored admissions at Months 0, 1 and 2 and receive matching oral placebo during each admission. XR-naltrexone 380 mg is administered intramuscularly on the planned calendar-monthly schedule at Months 0-11, for twelve injections. Participants receive equivalent preparation, clinical monitoring, psychological support, continuing care, monthly follow-up, SENTINEL support and Garmin monitoring through Month 12.
Drug: Extended-release naltrexone injection, 380 mg · Drug: Matching Oral Placebo · Device: My-E-Health SENTINEL Digital Monitoring and Human-Gated Escalation Platform · Behavioral: Standardized Psychological Preparation, Integration and Recovery Support · Other: Garmin-Enabled Longitudinal Wellness Monitoring
Twenty participants enter nonrandomly through the protocol-approved recent-opioid-use pathway. Three oral administrations of pharmaceutical-quality ibogaine hydrochloride are planned during monitored admissions at Months 0, 1 and 2, subject to eligibility and individual repeat-dose release. Matching IM placebo is administered on the planned calendar-monthly schedule at Months 0-11. The first admission includes clinically supervised stabilisation when required, with up to 48 hours allowed in the planning model. Equivalent preparation, clinical monitoring, psychological support, continuing care, monthly follow-up and SENTINEL/Garmin support continue through Month 12.
Drug: Ibogaine Hydrochloride · Drug: Matching Intramuscular Placebo · Device: My-E-Health SENTINEL Digital Monitoring and Human-Gated Escalation Platform · Behavioral: Standardized Psychological Preparation, Integration and Recovery Support · Other: Garmin-Enabled Longitudinal Wellness Monitoring
Twenty participants meeting the shared opioid-free and negative naloxone-challenge criteria are randomised 1:1 against Cohort A. Three oral administrations of pharmaceutical-quality ibogaine hydrochloride are planned during monitored admissions at Months 0, 1 and 2, subject to eligibility and individual repeat-dose release. Matching IM placebo is administered on the planned calendar-monthly schedule at Months 0-11. Equivalent preparation, clinical monitoring, psychological support, continuing care, monthly follow-up and SENTINEL/Garmin support continue through Month 12.
Drug: Ibogaine Hydrochloride · Drug: Matching Intramuscular Placebo · Device: My-E-Health SENTINEL Digital Monitoring and Human-Gated Escalation Platform · Behavioral: Standardized Psychological Preparation, Integration and Recovery Support · Other: Garmin-Enabled Longitudinal Wellness Monitoring
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
Participants With One or More Treatment-Emergent Serious Adverse Events or Prespecified Adverse Events of Special Interest
Number of participants who experience at least one treatment-emergent serious adverse event or prespecified adverse event of special interest. Prespecified events include death, cardiac arrest, torsade de pointes, ventricular tachycardia or ventricular fibrillation, protocol-defined clinically significant QTcF prolongation, syncope, seizure, aspiration, intensive-care transfer, severe agitation, mania, psychosis, suicide attempt, precipitated withdrawal meeting serious-adverse-event criteria, or overdose. Each participant will be counted once regardless of the number of qualifying events.
Time frame: From first assigned study intervention through 7 days after the third monitored admission, or 7 days after the last actual admission if the treatment course ends early.
Maximum Change From the Corresponding Pre-Dose Baseline in Fridericia-Corrected QT Interval
For each monitored admission, change in the Fridericia-corrected QT interval (QTcF) is calculated in milliseconds as each post-dose 12-lead ECG value minus the protocol-defined averaged pre-dose 12-lead ECG baseline for that admission. The outcome is the largest observed QTcF change for each participant across the three admissions. ECGs undergo clinical interpretation. This measure reports QTcF change only; threshold crossings and ventricular arrhythmias are separate outcomes.
Time frame: Pre-dose through 72 hours after each assigned treatment administration at Months 0, 1 and 2.
Participants With QTcF of at Least 500 Milliseconds
Number of participants with at least one post-intervention, clinically interpreted 12-lead ECG showing a Fridericia-corrected QT interval (QTcF) of 500 milliseconds or more during any monitored admission. Each participant is counted once regardless of the number of qualifying ECGs. The reported unit is participants.
Time frame: Pre-dose through 72 hours after each assigned treatment administration at Months 0, 1 and 2.
Participants With an Increase in QTcF of at Least 60 Milliseconds
Number of participants with at least one post-intervention increase in Fridericia-corrected QT interval (QTcF) of 60 milliseconds or more from the corresponding admission averaged pre-dose 12-lead ECG baseline. ECGs undergo clinical interpretation. Each participant is counted once regardless of the number of qualifying ECGs. The reported unit is participants.
Time frame: Pre-dose through 72 hours after each assigned treatment administration at Months 0, 1 and 2.
Participants With a Protocol-Defined Ventricular Arrhythmia
Number of participants with torsade de pointes, sustained or clinically significant ventricular tachycardia, ventricular fibrillation, or another protocol-defined ventricular-arrhythmia stopping event during the acute monitoring windows. Events are determined from continuous telemetry, clinically interpreted 12-lead ECGs and clinical adjudication. Each participant is counted once. The reported unit is participants.
Time frame: During the first 72 hours after each assigned treatment administration at Months 0, 1 and 2.
Area Under the Clinical Opiate Withdrawal Scale Total Score-Time Curve
Area under the total score-time curve from repeated Clinical Opiate Withdrawal Scale (COWS) assessments, reported in score-hours. COWS is an 11-item clinician-rated scale ranging from 0 to 48; higher scores indicate more severe withdrawal. The acute-withdrawal analysis population comprises participants with COWS of at least 5 at the prespecified pre-treatment baseline. Eligibility is assessed in each cohort, and results are reported separately by cohort. Cohort B is nonrandomised and is not pooled with Cohort C as a randomised comparison against Cohort A.
Time frame: From pre-treatment baseline through 72 hours after the first assigned treatment administration in participants meeting the acute-withdrawal analysis criteria.
Area Under the Subjective Opiate Withdrawal Scale Total Score-Time Curve
Area under the total score-time curve from repeated Subjective Opiate Withdrawal Scale (SOWS) assessments, reported in score-hours. The 16 participant-reported items each score from 0 (not at all) to 4 (extremely), giving a total score from 0 to 64. Higher scores indicate more severe withdrawal. Use the same prespecified acute-withdrawal analysis population as for COWS, with results reported separately by cohort.
Time frame: From pre-treatment baseline through 72 hours after the first assigned treatment administration in participants meeting the acute-withdrawal analysis criteria.
Change From Baseline in Objective Opiate Withdrawal Scale Total Score
The Objective Opiate Withdrawal Scale (OOWS) is a clinician-rated assessment of 13 observable signs of opioid withdrawal. Each sign is scored 0 if absent and 1 if present. The total score ranges from 0 to 13; higher scores indicate more severe withdrawal. Change is calculated as the total score at each follow-up assessment minus the pre-treatment baseline total score. Negative changes indicate improvement.
Time frame: Pre-treatment baseline; 24, 48 and 72 hours and Day 7 after first assigned treatment; weekly through Month 3 and monthly during Months 4 to 12.
Participants Requiring Withdrawal Rescue Treatment
Number of participants requiring protocol-defined withdrawal rescue medication, opioid re-administration or transfer to another withdrawal-management pathway. Rescue use is ascertained from medication-administration and clinical records. Each participant is counted once regardless of the number of rescue interventions. The reported unit is participants; rescue type and reason are recorded separately.
Time frame: From the first assigned treatment administration through 72 hours.
Number of Non-Prescribed Opioid-Use Days
Number of days with non-prescribed opioid use, assessed by Timeline Follow-Back and corroborated where possible by toxicology. A day is counted once regardless of the number of use episodes. Results are reported in days for each prespecified recall interval, separately by cohort. Prescribed opioid agonist treatment is distinguished from non-prescribed opioid use.
Time frame: Pre-treatment baseline and monthly assessments through Month 12.
Percentage of Participants With Toxicology-Supported Non-Prescribed Opioid Abstinence
Percentage of participants with no reported non-prescribed opioid use during the prespecified recall interval and a concordant toxicology result at the assessment. Participant report and the study toxicology assessment are the measurement sources. The recall interval, specimen and test panel, handling of prescribed treatment, analysis denominator and missing-result rule require final specification.
Time frame: Months 1, 3, 6 and 12 after first assigned study treatment.
Time to First Return to Non-Prescribed Opioid Use
Days from first assigned study treatment to the first protocol-defined return to non-prescribed opioid use among participants with established abstinence at the prespecified risk-set entry. Events are ascertained from participant reports and clinical or toxicology records. Ongoing use without established abstinence is not classified as a return to use.
Time frame: From the first assigned study treatment through Month 12.
Percentage of Participants Engaged in Continuing Addiction Treatment
Percentage of enrolled participants with documented current engagement in at least one continuing-care pathway at each assessment, including methadone, buprenorphine, naltrexone, behavioural treatment, residential treatment, mutual-help or another protocol-accepted pathway. Engagement is determined from clinical/treatment records and participant report. The numerator is participants meeting the engagement definition; the denominator is all enrolled participants in the corresponding cohort. The range is 0-100%, with higher values indicating greater engagement.
Time frame: Months 1, 3, 6 and 12 after first assigned study treatment.
Number of Overdose Events
Count of distinct fatal and nonfatal overdose events confirmed through clinical records, participant or collateral reports and independent clinical adjudication. Fatality and rescue interventions are recorded as event attributes. The reported unit is overdose events; repeat-event and episode-deduplication rules are prespecified.
Time frame: From the first assigned study treatment through Month 12.
Number of Naloxone Rescue Administrations
Count of documented naloxone administrations for suspected or confirmed overdose, ascertained from clinical, emergency-service and participant or collateral records. Each separate administration is counted, including repeated administrations during one overdose. The reported unit is administrations. Protocol naloxone challenges are excluded.
Time frame: From the first assigned study treatment through Month 12.
Number of Overdose-Related Emergency-Department Attendances
Count of emergency-department attendances for suspected or confirmed overdose, ascertained from clinical records and adjudication. The reported unit is attendances. Attendance episodes are deduplicated according to the prespecified event rules.
Time frame: From the first assigned study treatment through Month 12.
Number of Overdose-Related Hospital Admissions
Count of inpatient admissions for suspected or confirmed overdose, ascertained from clinical records and adjudication. Transfers within the same inpatient episode are not counted as new admissions under the prespecified episode rules. The reported unit is admissions.
Time frame: From the first assigned study treatment through Month 12.
Number of All-Cause Hospital Admissions
Count of inpatient hospital admissions for any cause, ascertained from clinical records and participant or collateral reports. Transfers within one inpatient episode are deduplicated. The reported unit is admissions. Planned research admissions are distinguished from clinical hospital admissions under the prespecified event rules.
Time frame: From the first assigned study treatment through Month 12.
Number of Intensive-Care Admissions
Count of intensive-care admissions for any cause, ascertained from clinical records. Episode and transfer rules are prespecified to avoid duplicate counting. The reported unit is intensive-care admissions.
Time frame: From the first assigned study treatment through Month 12.From the first assigned study treatment through Month 12.
Participants Who Die From Any Cause
Number of participants who die from any cause, established from clinical records, death records or other verified source documentation. Each participant is counted once. Cause and relationship to study treatment are recorded separately. The reported unit is participants.
Time frame: From the first assigned study treatment through Month 12.
Participants With One or More Prespecified Suicide-Related Adverse Events
Number of participants with at least one qualifying suicide-related event, counted once regardless of the number of events. Event categories include qualifying suicidal ideation, suicide attempt, self-injury, crisis intervention, psychiatric hospitalisation or suicide death, as defined in the protocol. Events are ascertained using the selected suicide assessment, clinical records and clinical adjudication.
Time frame: Baseline through Month 12.
Change From Baseline in Health-Related Quality of Life
Change from the pre-treatment baseline in the selected quality-of-life score. The instrument, version, specific score or domain, score range, direction and applicable value set must be selected before this outcome is released. Distinct index, visual-analogue or domain scores will be entered as separate measures if more than one is adopted.
Time frame: Pre-treatment baseline and Months 1, 3, 6 and 12 after first assigned study treatment.
Change From Baseline in Patient Health Questionnaire-9 Total Score
The Patient Health Questionnaire-9 (PHQ-9) is a 9-item participant-reported measure of depressive symptoms over the preceding 2 weeks. Each item is scored from 0 to 3, giving a total score from 0 to 27. Higher total scores indicate more severe depressive symptoms. Change is calculated as the score at each follow-up assessment minus the pre-treatment baseline score; negative changes indicate improvement.
Time frame: Pre-treatment baseline and weekly through Month 12 after the first assigned treatment administration.
Change From Baseline in Generalized Anxiety Disorder-7 Total Score
The Generalized Anxiety Disorder-7 (GAD-7) is a 7-item participant-reported measure of anxiety symptoms over the preceding 2 weeks. Each item is scored from 0 to 3, giving a total score from 0 to 21. Higher total scores indicate more severe anxiety symptoms. Change is calculated as the score at each follow-up assessment minus the pre-treatment baseline score; negative changes indicate improvement.
Time frame: Pre-treatment baseline and weekly through Month 12 after the first assigned treatment administration.
Change From Baseline in PTSD Checklist for DSM-5 Total Score
The PTSD Checklist for DSM-5 (PCL-5) is a 20-item participant-reported measure of post-traumatic stress symptoms. Each item is scored from 0 to 4, giving a total score from 0 to 80. Higher scores indicate greater symptom severity. Change is the total score at each follow-up minus the pre-treatment baseline total; negative changes indicate improvement. Results are reported for participants meeting the prespecified trauma-analysis criteria.
Time frame: Pre-treatment baseline and Months 1, 3, 6 and 12 after first assigned treatment.
Change From Baseline in EFP Mini Total Score
Change from the pre-treatment baseline in the EFP Mini overall score at each analysis visit. The study uses the 51-item EFP Mini assessment. The instrument owner must verify the official name, item coding, direction, reverse scoring, missing-item rules and validity of the overall total before the numerical range and interpretation are finalised. If only domain scores are adopted, each domain will be specified separately.
Time frame: Pre-treatment baseline and Months 1, 3, 6 and 12 after first assigned study treatment.
Percentage of Participants Completing the Month 12 Clinical Outcome Assessment
Percentage of enrolled participants who complete the protocol-defined Month 12 clinical outcome assessment. The numerator is participants completing that assessment; the denominator is all enrolled participants in the corresponding cohort, multiplied by 100. The range is 0-100%, with higher percentages indicating greater follow-up retention. Reasons for non-completion, including withdrawal, loss to follow-up and death, are reported separately.
Time frame: Month 12 after first assigned study treatment.
Percentage of Expected Daily Check-Ins Completed
For each participant, 100 multiplied by the number of completed scheduled SENTINEL daily check-ins divided by the number expected during follow-up. Completion is determined from platform audit records. Expected days exclude only the protocol-scheduled acute-admission pauses; unscheduled non-completion remains missing. The range is 0-100%, with higher values indicating greater adherence.
Time frame: From activation of baseline monitoring through Month 12.
Percentage of Expected Wearable-Data Days Available
For each participant, 100 multiplied by the number of days with evaluable Garmin data divided by the number of expected monitoring days. Evaluable days meet the prespecified minimum wear and data-coverage criteria. Expected days exclude only protocol-scheduled acute-admission pauses; unscheduled missingness is retained. The range is 0-100%, with higher values indicating greater data availability.
Time frame: From activation of baseline monitoring through Month 12.
Percentage of Scheduled Remote Assessments Completed
For each participant, 100 multiplied by the number of completed scheduled remote assessments divided by the number expected. Completion and expected assessments are determined from the protocol schedule and platform records, including approved acute-admission pause rules. Unscheduled missingness is retained. The range is 0-100%, with higher values indicating greater adherence.
Time frame: From activation of baseline monitoring through Month 12.
Participants With Adverse Events During 12-Month Follow-Up
Number of participants with one or more serious or non-serious adverse events from first assigned treatment through Month 12, ascertained from clinical review, participant reports and source records. Each participant is counted once. Cardiovascular, neurological, psychiatric, overdose and substance-use event categories are recorded separately. This observation window includes and overlaps the acute primary safety window.
Time frame: From the first assigned study treatment through Month 12.
Participants Enrolled by Cohort
Number of participants enrolled into each of Cohorts A, B and C, reported separately. Enrolment is established from signed consent and the study enrolment records under the protocol definition. Screening totals and reasons for non-enrolment are recorded separately. The reported unit is participants.
Time frame: From the start of screening through closure of study enrolment.
Cohort B Participants Completing Protocol-Defined Stabilisation
Number of Cohort B entrants who satisfy the approved first-session stabilisation criteria before their first ibogaine administration. Status is determined by the clinical team from the stabilisation assessment and source records. The number entering stabilisation is reported as the denominator. The reported outcome unit is participants.
Time frame: During the first admission, before the first ibogaine administration.
Participants Completing All Three Assigned Treatment Sessions
Number of participants who receive all three assigned oral treatment administrations at Months 0, 1 and 2: matching oral placebo in Cohort A or ibogaine in Cohorts B and C. Completion is determined from treatment-administration records and reported separately by cohort. Missed or stopped sessions and reasons are recorded. The reported unit is participants.
Time frame: From the Month 0 session through completion of the Month 2 session.
Change From Baseline in Opioid Craving
Change from the pre-treatment baseline in the protocol-selected opioid-craving score. The instrument, version, item and total scoring, recall period, direction of interpretation and analysis rule require selection before registration. The selected score will be reported separately from withdrawal and other psychological assessments.
Time frame: Pre-treatment baseline; weekly through Month 3 and monthly during Months 4 to 12.
Change From Baseline in Garmin-Derived Total Sleep Duration
Change in Garmin-derived nightly total sleep duration, calculated as the mean for each follow-up month minus the mean over the participant's pre-treatment baseline period. The unit is minutes per night. The outcome quantifies change and is not interpreted as a diagnostic test.
Time frame: Daily during the pre-treatment baseline period and through Month 12; changes summarised separately for Months 1 to 12.
Change From Baseline in Garmin Derived Light Sleep Duration
Change in Garmin-derived nightly device-estimated light sleep duration, calculated as the mean for each follow-up month minus the mean over the participant's pre-treatment baseline period. The unit is minutes per night. The outcome quantifies change and is not interpreted as a diagnostic test.
Time frame: Daily during the pre-treatment baseline period and through Month 12; changes summarised separately for Months 1 to 12.
Change From Baseline in Garmin Derived Deep Sleep Duration
Change in Garmin-derived nightly device-estimated deep sleep duration, calculated as the mean for each follow-up month minus the mean over the participant's pre-treatment baseline period. The unit is minutes per night. The outcome quantifies change and is not interpreted as a diagnostic test.
Time frame: Daily during the pre-treatment baseline period and through Month 12; changes summarised separately for Months 1 to 12.
Change From Baseline in Garmin Derived Rapid Eye Movement Sleep Duration
Change in Garmin-derived nightly device-estimated rapid eye movement sleep duration, calculated as the mean for each follow-up month minus the mean over the participant's pre-treatment baseline period. The unit is minutes per night. The outcome quantifies change and is not interpreted as a diagnostic test.
Time frame: Daily during the pre-treatment baseline period and through Month 12; changes summarised separately for Months 1 to 12.
Change From Baseline in Garmin Derived Resting Heart Rate
Change in Garmin-derived daily resting heart rate, calculated as the mean for each follow-up month minus the mean over the participant's pre-treatment baseline period. The unit is beats per minute. No universal direction of clinical improvement is assigned to this exploratory physiological measure.
Time frame: Daily during the pre-treatment baseline period and through Month 12; changes summarised separately for Months 1 to 12.
Change From Baseline in Garmin Derived Overnight Heart Rate Variability
Change in Garmin-derived device-reported mean overnight heart rate variability, calculated as the mean for each follow-up month minus the mean over the participant's pre-treatment baseline period. The unit is milliseconds. No universal direction of clinical improvement is assigned to this exploratory physiological measure.
Time frame: Daily during the pre-treatment baseline period and through Month 12; changes summarised separately for Months 1 to 12.
Change From Baseline in Garmin Derived Overnight Respiratory Rate
Change in Garmin-derived mean overnight respiratory rate, calculated as the mean for each follow-up month minus the mean over the participant's pre-treatment baseline period. The unit is breaths per minute. No universal direction of clinical improvement is assigned to this exploratory physiological measure.
Time frame: Daily during the pre-treatment baseline period and through Month 12; changes summarised separately for Months 1 to 12.
Change From Baseline in Garmin Derived Overnight Oxygen Saturation
Change in Garmin-derived mean overnight peripheral oxygen saturation estimated by the wearable, calculated as the mean for each follow-up month minus the mean over the participant's pre-treatment baseline period. The unit is percentage points for change in oxygen saturation. No universal direction of clinical improvement is assigned to this exploratory physiological measure.
Time frame: Daily during the pre-treatment baseline period and through Month 12; changes summarised separately for Months 1 to 12.
Change From Baseline in Garmin Derived Daily Step Count
Change in Garmin-derived daily step count, calculated as the mean for each follow-up month minus the mean over the participant's pre-treatment baseline period. The unit is steps per day. The outcome quantifies change and is not interpreted as a diagnostic test.
Time frame: Daily during the pre-treatment baseline period and through Month 12; changes summarised separately for Months 1 to 12.
Change From Baseline in Garmin Derived Daily Physical Activity Duration
Change in Garmin-derived daily duration of physical activity meeting the prespecified device-derived activity definition, calculated as the mean for each follow-up month minus the mean over the participant's pre-treatment baseline period. The unit is minutes per day. The outcome quantifies change and is not interpreted as a diagnostic test.
Time frame: Daily during the pre-treatment baseline period and through Month 12; changes summarised separately for Months 1 to 12.
Change From Baseline in Garmin All Day Stress Score
Change in the monthly mean of Garmin daily all-day stress scores from the mean over the pre-treatment baseline period. Scores range from 0 to 100; higher values indicate greater device-estimated physiological stress. Change is follow-up minus baseline and is reported in score points. Negative changes indicate lower estimated stress. This measure is distinct from a psychological stress questionnaire and from the separate Garmin HRV stress test.
Time frame: Daily during the pre-treatment baseline period and through Month 12; changes summarised separately for Months 1 to 12.
Change From Baseline in Garmin Body Battery Score
Change in the monthly mean of daily maximum Garmin Body Battery scores from the mean over the pre-treatment baseline period. For the Garmin Venu 4 implementation specified here, scores range from 5 to 100; higher values indicate greater device-estimated energy reserves. Change is follow-up minus baseline and is reported in score points. Positive changes indicate higher estimated reserves. This is an exploratory proprietary wearable score.
Time frame: Daily during the pre-treatment baseline period and through Month 12; changes summarised separately for Months 1 to 12.
Number of Transitions Into the Yellow SENTINEL Risk State
Number of distinct transitions into the Yellow risk state recorded by SENTINEL for each participant. A transition is a change from a different state into Yellow; repeated notifications for the same unchanged state are not counted as new transitions. The unit is transitions per participant. Counts describe escalation activity and are not themselves a measure of clinical benefit.
Time frame: From activation of baseline SENTINEL monitoring through Month 12.
Number of Transitions Into the Orange SENTINEL Risk State
Number of distinct transitions into the Orange risk state recorded by SENTINEL for each participant. A transition is a change from a different state into Orange; repeated notifications for the same unchanged state are not counted as new transitions. The unit is transitions per participant. Counts describe escalation activity and are not themselves a measure of clinical benefit.
Time frame: From activation of baseline SENTINEL monitoring through Month 12.
Number of Transitions Into the Red SENTINEL Risk State
Number of distinct transitions into the Red risk state recorded by SENTINEL for each participant. A transition is a change from a different state into Red; repeated notifications for the same unchanged state are not counted as new transitions. The unit is transitions per participant. Counts describe escalation activity and are not themselves a measure of clinical benefit.
Time frame: From activation of baseline SENTINEL monitoring through Month 12.
Number of Transitions Into the Urgent SENTINEL Risk State
Number of distinct transitions into the Urgent risk state recorded by SENTINEL for each participant. A transition is a change from a different state into Urgent; repeated notifications for the same unchanged state are not counted as new transitions. The unit is transitions per participant. Counts describe escalation activity and are not themselves a measure of clinical benefit.
Time frame: From activation of baseline SENTINEL monitoring through Month 12.
Percentage of Escalations Receiving Required Human Review
Percentage of risk-state transitions requiring human review that receive documented review by the responsible qualified clinician within the applicable protocol-defined response window. The numerator is eligible transitions reviewed within that window; the denominator is all transitions requiring review. The result is multiplied by 100. The range is 0 to 100%, with higher percentages indicating better adherence to the review requirement.
Time frame: From activation of baseline SENTINEL monitoring through Month 12.
Time From Escalation to First Attempted Clinician Contact
Elapsed time in minutes from an Orange, Red or Urgent transition requiring contact to the first documented contact attempt by the assigned clinician. Timing starts at the transition timestamp. The time-to-contact distribution will include escalations without an attempt under the prespecified censoring rule. Smaller times indicate faster attempted contact; unsuccessful or absent attempts will not be treated as zero time.
Time frame: For eligible transitions from activation of baseline SENTINEL monitoring through Month 12.
Time From Escalation to First Completed Clinician Contact
Elapsed time in minutes from an Orange, Red or Urgent transition requiring contact to the first documented two-way contact between the assigned clinician and participant. Timing starts at the transition timestamp. The time-to-contact distribution will include escalations without completed contact under the prespecified censoring rule. Smaller times indicate faster completed contact; an unanswered call or automated message is not completed contact.
Time frame: For eligible transitions from activation of baseline SENTINEL monitoring through Month 12.
False Positive Rate of SENTINEL Clinical Escalations
For prespecified evaluable participant-day windows, the percentage of reference-negative windows that contain a qualifying false-positive escalation. Independent clinical adjudication determines whether the target clinical event occurred. False-positive rate is 100 multiplied by false positives divided by false positives plus true negatives. The range is 0 to 100%, with lower values indicating fewer false positives. Alert thresholds, target events and event-matching rules are fixed before analysis.
Time frame: From activation of baseline SENTINEL monitoring through Month 12.
Percentage of Adjudicated Clinical Events Missed by SENTINEL
Percentage of independently adjudicated target clinical events without a matching qualifying SENTINEL escalation in the prespecified detection window. The missed-event percentage is 100 multiplied by false negatives divided by true positives plus false negatives. The range is 0 to 100%, with lower values indicating fewer missed events. Events are ascertained through clinical follow-up and source records independently of whether SENTINEL generated an alert.
Time frame: From activation of baseline SENTINEL monitoring through Month 12.
Clinician Alert Burden per Participant Week
Number of distinct SENTINEL alerts requiring clinician action divided by evaluable participant-weeks of monitoring. Duplicate notifications for the same alert are handled according to the prespecified deduplication rule. The unit is alerts per participant-week. The rate describes clinician workload; a lower rate is not assumed to indicate better safety without the accompanying detection-performance results.
Time frame: From activation of baseline SENTINEL monitoring through Month 12.
Plasma Ibogaine Concentration
Plasma ibogaine concentration is measured in ng/mL using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) assay. Concentrations are reported at each scheduled sampling time for ibogaine-treated participants in Cohorts B and C. The assessment includes pre-dose and acute post-dose samples at the three treatment admissions and follow-up samples at Months 3 and 6. Actual sample times are recorded. Handling of values below the lower limit of quantification is prespecified in the statistical analysis plan. This outcome measures concentration only; concentration-QTc slopes are reported separately.
Time frame: Pre-dose and during the first 72 hours after each ibogaine administration at Months 0, 1 and 2, with additional plasma samples at Months 3 and 6.
Plasma Noribogaine Concentration
Plasma noribogaine concentration is measured in ng/mL using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) assay. Concentrations are reported at each scheduled sampling time for ibogaine-treated participants in Cohorts B and C. The assessment includes pre-dose and acute post-dose samples at the three treatment admissions and follow-up samples at Months 3 and 6. Pre-dose samples at repeat admissions quantify residual noribogaine. Actual sample times are recorded. Handling of values below the lower limit of quantification is prespecified in the statistical analysis plan. This outcome measures concentration only; concentration-QTc slopes are reported separately.
Time frame: Pre-dose and during the first 72 hours after each ibogaine administration at Months 0, 1 and 2, with additional plasma samples at Months 3 and 6.
Concentration-Response Slope for Plasma Ibogaine and Change in QTcF
The outcome is the regression slope, with a 95% confidence interval, for change in Fridericia-corrected QT interval (QTcF) per 10 ng/mL higher plasma ibogaine concentration. Plasma ibogaine is measured in ng/mL by validated liquid chromatography-tandem mass spectrometry (LC-MS/MS). QTcF is measured in milliseconds using serial 12-lead electrocardiograms with cardiologist over-read. QTcF change is the post-dose value minus the corresponding admission pre-dose mean. A linear mixed-effects model in ibogaine-treated Cohorts B and C uses time-matched concentration-ECG pairs, accounts for repeated observations within participants and admissions, and adjusts for nominal time, session, cohort, pre-dose QTcF and pre-dose ibogaine concentration. The single reported unit is ms per 10 ng/mL; a positive slope indicates greater QTcF prolongation at higher concentrations. This is an exploratory estimate, not a clinical safety threshold.
Time frame: Time-matched plasma samples and 12-lead ECGs from pre-dose through 72 hours after each ibogaine administration at Months 0, 1 and 2.
Concentration-Response Slope for Plasma Noribogaine and Change in QTcF
The outcome is the regression slope, with a 95% confidence interval, for change in Fridericia-corrected QT interval (QTcF) per 10 ng/mL higher plasma noribogaine concentration. Plasma noribogaine is measured in ng/mL by validated liquid chromatography-tandem mass spectrometry (LC-MS/MS). QTcF is measured in milliseconds using serial 12-lead electrocardiograms with cardiologist over-read. QTcF change is the post-dose value minus the corresponding admission pre-dose mean. A linear mixed-effects model in ibogaine-treated Cohorts B and C uses time-matched concentration-ECG pairs, accounts for repeated observations within participants and admissions, and adjusts for nominal time, session, cohort, pre-dose QTcF and pre-dose noribogaine concentration. The single reported unit is ms per 10 ng/mL; a positive slope indicates greater QTcF prolongation at higher concentrations. This is an exploratory estimate, not a clinical safety threshold.
Time frame: Time-matched plasma samples and 12-lead ECGs from pre-dose through 72 hours after each ibogaine administration at Months 0, 1 and 2.
Treatment-Guess Distribution by Masked Role
Number of correct, incorrect and do-not-know treatment guesses, recorded on a standardised treatment-guess form after each monitored admission in the randomised A/C comparison. Counts are reported separately by admission and masked role, including participants and designated masked investigators or assessors. Each respondent contributes one response per scheduled assessment. The unit is responses in each category; no derived blinding index is included in this measure.
Time frame: After each monitored admission at Months 0, 1 and 2.
Percentage of Telemetry-Detected Cardiac Events Captured by Scheduled Intermittent ECGs
Percentage of independently adjudicated qualifying cardiac events detected by continuous telemetry that are also captured by the scheduled intermittent 12-lead ECG assessments. The numerator is qualifying telemetry events with a matching ECG detection; the denominator is all qualifying telemetry events with an evaluable matching opportunity, multiplied by 100. Results range from 0 to 100%. Event eligibility, matching windows and adjudication are prespecified. This observational comparison does not change required telemetry or emergency monitoring.
Time frame: During the first 72 hours after each assigned treatment administration at Months 0, 1 and 2.
CYP2D6-Related Exposure Analysis
Reserved exploratory analysis of the relationship between a prespecified CYP2D6 genotype or phenotype measure and ibogaine or noribogaine exposure. Genotyping or phenotyping method, category definitions, the single pharmacokinetic outcome, population, statistical estimate and unit require selection before a final outcome can be registered. Distinct parent and metabolite pharmacokinetic measures will be separated if both are selected.
Time frame: Baseline CYP2D6 assessment and pharmacokinetic observations at Months 0, 1 and 2.
Plan to share: Yes — The sponsor plans to make available a deidentified individual-participant dataset underlying the primary and secondary results, together with the data dictionary, study protocol, statistical analysis plan, informed-consent form, and relevant analytic code. Access will be considered for qualified researchers whose proposed use has received scientific and ethical review and who enter into a data-use agreement protecting participant privacy, Indigenous and community interests, commercial confidential information, and investigational-product information. Data are expected to become available approximately 12 months after publication of the principal results and remain available for at least five years. Access will be provided through a controlled-access repository or secure analysis environment. Direct identifiers, free-text clinical conversations, exact locations, device identifiers, and other information presenting an unacceptable re-identification risk will not be released. Wearable da
Supporting information: Study protocol, Clinical study report
Time frame: Beginning 12 months after publication of the primary manuscript and continuing for five years
Access criteria: Qualified researchers with an approved methodologically sound proposal, appropriate ethics approval or exemption, and an executed data-use agreement
Data sharing details ↗ · www.my-e-health.com
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Studies of the drug tested here: Ibogaine hydrochloride