Summary
Ibogaine has reached Preclinical as its most advanced recorded development stage across any indication, and the database holds no approval for Opioid Use Disorder. ClinicalTrials.gov lists 3 registered trials linking Ibogaine to Opioid Use Disorder: 1 is currently recruiting; 2 have completed. The most advanced is Phase 2 (NCT04003948). The largest enrolment is 116 participants (NCT05029401). Registration activity spans 2020 to 2025. The literature layer holds 3 publications for this pair: 1 systematic review and 2 clinical trial publications. Publication years run from 1999 to 2025. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for Opioid Use Disorder ranks 289 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Spontaneous recovery (without MOUD) in 20-30% of OUD patients over 10 years; but overdose mortality risk during active disorder is extreme (5-10 per 1000 person-years); relapse rate 90%+ in first year after discontinuing MOUD.
Evidence table
| Evidence tier | C · Preliminary |
|---|---|
| Evidence score | 21.0 (trials 9.0, literature 7.0, tier 5, approved bonus 0.0) |
| Registered trials | 3 total: 1 recruiting, 0 active / not yet recruiting, 2 completed, 0 other |
| Linked publications | 3 (2 clinical trial publications, 1 systematic review) |
| Agent type | Drug (Psychedelic) |
| Development stage (any indication) | Preclinical |
| Mechanism / class | Therapeutic potential of herbalism for opioid use disorder · Halma M, Hesse C, Selem E, Varon J · 2025 |
| Data sources | OSMF Chronic Disease Review |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT04003948 | Preliminary Efficacy and Safety of Ibogaine in the Treatment of Methadone Detoxification 2020 | completed | Phase 2 | 20 |
| NCT05029401 | A Study of Oral Ibogaine in Opioid Withdrawal 2021 | completed | PHASE1, PHASE2 | 116 |
| NCT07226570 | Mapping Ibogaine Neural Dynamics in Opioid Use Disorder 2025 | recruiting | Not applicable | 20 |
Published literature
- Systematic review The therapeutic effects of psychedelics for opioid use disorder: A systematic review of clinical studiesWeleff J, Pulido-Saavedra A, Aghaei AM et al. · Psychiatry research · 2025 · PMID 40147088
- Clinical trial publication Ascending Single-Dose, Double-Blind, Placebo-Controlled Safety Study of Noribogaine in Opioid-Dependent PatientsGlue P, Cape G, Tunnicliff D et al. · Clinical pharmacology in drug development · 2016 · PMID 27870477
- Clinical trial publication Treatment of acute opioid withdrawal with ibogaineAlper KR, Lotsof HS, Frenken GM et al. · The American journal on addictions · 1999 · PMID 10506904
Mechanism and notes
Recorded mechanism or class: Therapeutic potential of herbalism for opioid use disorder · Halma M, Hesse C, Selem E, Varon J · 2025.
OSMF's existing evidence tier for this pair is C (Preliminary), derived from the strength of the disease association recorded in OSMF Chronic Disease Review. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Ibogaine approved for Opioid Use Disorder?
Ibogaine has reached Preclinical as its most advanced recorded development stage across any indication, and the database holds no approval for Opioid Use Disorder. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Ibogaine in clinical trials for Opioid Use Disorder?
ClinicalTrials.gov lists 3 registered trials linking Ibogaine to Opioid Use Disorder: 1 is currently recruiting; 2 have completed. The most advanced is Phase 2 (NCT04003948). The largest enrolment is 116 participants (NCT05029401). Registration activity spans 2020 to 2025.
What does the evidence show for Ibogaine in Opioid Use Disorder?
Ibogaine has both completed registered trials and synthesis-level publications linked to Opioid Use Disorder. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is C (Preliminary), derived from the strength of the disease association recorded in OSMF Chronic Disease Review. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.