[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Clive Michelsen\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":65},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":32,"overallStatus":53,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":5},"100659937","phase-1-medically-supervised-ibogaine-with-12-month-digital-recovery-support-for-opioid-use-disorder-100659937",false,"NCT07871877","Medically Supervised Ibogaine With 12-Month Digital Recovery Support for Opioid Use Disorder","A Phase 1\u002F2a Three-Cohort Study of Ibogaine Versus Extended-Release Naltrexone With 12-Month Recovery Support in Opioid Use Disorder: A Randomised Double-Dummy Comparison and a Recent-Use Cohort","IBO-CARE","Inclusion Criteria\n\n1. Adult aged 18 to 65 years, inclusive.\n2. 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.\n3. 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\u002FC after at least 30 opioid-free days remain eligible if they otherwise meet the approved criteria. Cohort-specific entry rules govern assignment.\n4. Is voluntarily seeking treatment and has a documented clinical need for an additional treatment option, demonstrated by one or more of the following: Previous unsuccessful evidence-based treatment or medically supervised withdrawal; Relapse following treatment; Difficulty remaining engaged in treatment despite reasonable support; Previous overdose or clinically significant overdose risk; Intolerance of or insufficient response to a standard treatment; An informed and persistent preference to discontinue opioid agonist treatment after available alternatives have been explained.\n5. Has received a balanced explanation of available evidence-based treatments, including methadone, buprenorphine, extended-release naltrexone where clinically appropriate, psychosocial treatment, naloxone, and continuing addiction care.\n6. If receiving methadone, buprenorphine, or another long-acting opioid, has a written specialist-supervised transition and continuity plan that avoids abrupt or unsupervised discontinuation and preserves rapid re-entry to opioid agonist treatment where clinically indicated.\n7. A Clinical Opiate Withdrawal Scale total score of at least 5 at the prespecified pre-treatment baseline is required only for the acute-withdrawal endpoint analysis, not for all study enrolment. Analysis eligibility is defined before treatment.\n8. Is medically and psychiatrically stable enough to participate, based on review by the principal investigator, addiction-medicine physician, cardiologist, and medical monitor.\n9. Demonstrates decision-making capacity and provides written informed consent.\n10. Has completed the required medical evaluation, including physical and neurological examination, medication and supplement review, laboratory testing, substance-use testing, and cardiac assessment.\n11. Has protocol-acceptable screening and immediate pre-dose 12-lead electrocardiogram findings, including a Fridericia-corrected QT interval no greater than 450 milliseconds for males and no greater than 470 milliseconds for females, unless stricter limits are required by the FDA-authorised protocol.\n12. Has clinically acceptable serum potassium, magnesium, calcium, renal function, hepatic function, haematology, and other protocol-required laboratory results. Correctable abnormalities must be corrected and rechecked before treatment.\n13. Is willing to remain at the clinical site throughout the required inpatient and observation period and participate in continuous telemetry, serial 12-lead electrocardiograms, laboratory testing, clinical examinations, and emergency procedures.\n14. Is willing to participate in psychological preparation, recovery planning, continuing addiction care, and 12 months of in-person and remote follow-up.\n15. Is willing to use SENTINEL, the study-provided Garmin Venu 4 and Apple phone. Equipment, connectivity, training and accessibility support are provided as needed. Lack of personal equipment alone does not exclude participation.\n16. Provides a reliable means of contact and, where permitted, identifies an emergency contact or supporting person.\n17. Participants of reproductive potential agree to protocol-required pregnancy testing and contraception requirements.\n\nCohort Specific Entry Criteria\n\n1. Cohorts A and C: Complete the protocol-approved opioid-free interval and negative naloxone challenge before randomisation and treatment. The proposed stratification is 7-29 versus at least 30 opioid-free days. The precise counting method, opioid-specific safe interval, challenge procedure and naltrexone eligibility must be fixed under D6. No universal 30-day abstinence requirement applies. Naltrexone contraindications, product\u002Fexcipient allergies and injection suitability must be checked before randomisation.\n2. Cohort B: Meet the approved recent-use entry pathway without a mandatory 30-day abstinence period. First-session stabilisation may require up to 48 hours in the planning model. Current methadone treatment does not permit direct entry. Previous methadone or buprenorphine treatment does not automatically exclude a person for life, but the approved specialist transition and objective readiness criteria must be satisfied before dosing. The recent-use interval, prohibited medicines and objective stabilisation criteria require D3\u002FD6 confirmation.\n3. Clinical Priority: Evidence-based treatment, safe withdrawal management and emergency care take priority over research enrolment. A medically necessary therapy must not be stopped solely to qualify where discontinuation would create greater risk.\n\nExclusion Criteria\n\n1. Congenital or acquired long-QT syndrome.\n2. Fridericia-corrected QT interval greater than 450 milliseconds for males or greater than 470 milliseconds for females on a protocol-qualifying screening or pre-dose electrocardiogram, or a stricter threshold required by the FDA-authorised protocol.\n3. History or current evidence of clinically important cardiac disease that could materially increase arrhythmia or haemodynamic risk, including: Torsade de pointes; Ventricular tachycardia or ventricular fibrillation; Previous sudden cardiac arrest; Clinically significant conduction disease; Brugada syndrome; Unexplained cardiac syncope; Cardiomyopathy; Significant heart failure; Significant valvular disease; Active myocarditis or pericarditis; Active or inadequately treated infective endocarditis; Unstable coronary disease; Recent myocardial infarction; Clinically significant atrial or ventricular arrhythmia.\n4. Family history suggesting an inherited arrhythmia syndrome or unexplained premature sudden cardiac death, unless specialist assessment establishes acceptable risk under the protocol.\n5. Clinically significant bradycardia, tachycardia, uncontrolled hypertension, symptomatic hypotension, or autonomic instability that has not been corrected before treatment.\n6. Uncorrected hypokalaemia, hypomagnesaemia, hypocalcaemia, or another clinically significant electrolyte or acid-base abnormality.\n7. Clinically significant hepatic impairment, decompensated liver disease, acute hepatitis, impaired hepatic synthetic function, or laboratory abnormalities expected to alter ibogaine or noribogaine exposure materially.\n8. Clinically significant renal impairment or unstable renal disease.\n9. Unstable respiratory, neurological, endocrine, gastrointestinal, haematological, infectious, or other systemic disease that could increase the risk of treatment, aspiration, arrhythmia, vomiting, immobility, or emergency intervention.\n10. Current sepsis, uncontrolled systemic infection, active infective endocarditis, or another infection requiring urgent treatment.\n11. Current pregnancy, intended pregnancy during the protocol-defined risk period, or breastfeeding.\n12. Known hypersensitivity or previous serious adverse reaction to ibogaine, noribogaine, another iboga alkaloid, or an investigational-product excipient.\n13. Previous ibogaine exposure associated with clinically significant QT prolongation, arrhythmia, syncope, seizure, mania, psychosis, cardiac arrest, or another serious adverse event.\n14. Use of a medication, supplement, or substance that creates unacceptable risk through one or more of the following: QT prolongation or torsade de pointes; Bradycardia or conduction disturbance; Clinically significant cytochrome P450 2D6 inhibition or induction; Serotonergic toxicity; Reduction of the seizure threshold; Excessive sedation or respiratory depression; Hemodynamic instability.\n15. Inability to discontinue, substitute, or medically transition from a prohibited medication within a pharmacologically justified period. A medically necessary treatment will not be stopped solely to qualify for enrolment where discontinuation would create greater risk.\n16. Current methadone, buprenorphine, or another long-acting opioid unless the participant has completed the protocol-approved specialist-led transition procedure and has a written post-intervention treatment plan.\n17. Recent cocaine, methamphetamine, amphetamine, 3,4-methylenedioxymethamphetamine, or another stimulant exposure within the protocol-defined safety period, or a pre-dose toxicology finding considered to create unacceptable cardiovascular risk.\n18. Current alcohol, benzodiazepine, barbiturate, or other sedative-hypnotic dependence requiring separate withdrawal management, or current risk of alcohol- or sedative-withdrawal seizure or delirium.\n19. Severe uncontrolled polysubstance dependence requiring simultaneous medical detoxification or preventing interpretable safety assessment.\n20. Current intoxication, delirium, severe uncontrolled withdrawal, or another condition preventing valid informed consent or safe study procedures.\n21. History of epilepsy, an unprovoked seizure, a clinically significant seizure disorder, or a recent withdrawal-related seizure, unless specifically reviewed and accepted under the FDA-authorised protocol.\n22. Current psychotic disorder, active psychotic symptoms, schizophrenia-spectrum disorder, or current substance-induced psychosis.\n23. Current manic or hypomanic episode, uncontrolled bipolar I disorder, or previous ibogaine- or psychedelic-associated mania.\n24. Current suicidal intent, active suicide plan, recent high-lethality suicide attempt requiring acute intervention, or imminent risk of serious self-harm.\n25. Current homicidal intent, severe uncontrolled aggression, or behavioural instability that cannot be managed safely in the research setting.\n26. Severe cognitive impairment or another condition preventing informed consent or meaningful participation.\n27. An acute medical or psychiatric condition for which hospitalisation or another higher level of care takes priority over research participation.\n28. Receipt of another investigational drug within 30 days or five elimination half-lives, whichever is longer, unless specifically authorised by the sponsor and medical monitor.\n29. Inability or unwillingness to remain in the monitored treatment setting for the required period.\n30. Inability or unwillingness to participate in 12-month follow-up despite reasonable language, disability, equipment, connectivity, and technical accommodations.\n31. Any condition that, in the judgment of the principal investigator, cardiologist, addiction-medicine physician, psychiatrist, or independent medical monitor, would expose the participant to unreasonable risk, compromise informed consent, interfere materially with interpretation, or make participation contrary to the participant's interests.","ALL","18 Years","65 Years",{"count":21,"type":22},60,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","IBO-CARE is a single-site Phase 1\u002F2a 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.",[29,30,31],"Opioid Use Disorder","Opioid Withdrawal","Substance Use Disorders",[33,34,35,29,30,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,15],"Ibogaine","Ibogaine Hydrochloride","Noribogaine","Opioid Dependence","Craving","Detoxification","Relapse","Overdose Prevention","Psychedelic-Assisted Treatment","Addiction Medicine","Digital Recovery Support","Remote Patient Monitoring","Wearable Technology","Garmin","Quality of Life","Continuing Care","Heart Rate Variability","QTc Prolongation","Clinical Opiate Withdrawal Scale","My-E-Health","NOT_YET_RECRUITING","2026-10-06",{"date":56,"type":57},"2026-10-13","ACTUAL",{"date":59,"type":22},"2027-07-01",{"date":61,"type":22},"2029-12-31",{"name":63,"class":64},"Clive Michelsen","INDUSTRY",""]