Summary
Buprenorphine has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Opioid Use Disorder would be drug repurposing rather than first-in-human development. This does not mean it is approved for Opioid Use Disorder. ClinicalTrials.gov lists 8 registered trials linking Buprenorphine to Opioid Use Disorder: 2 are currently recruiting; 2 are active or not yet recruiting; 3 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT03818399). The largest enrolment is 27257 participants (NCT05944133). Registration activity spans 2017 to 2026. The literature layer holds 17 publications for this pair: 5 Cochrane reviews, 4 meta-analyses, 3 systematic reviews and 5 clinical trial publications. Publication years run from 2025 to 2026. 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 | A · Strong |
|---|---|
| Evidence score | 71.5 (trials 21.5, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 2 recruiting, 2 active / not yet recruiting, 3 completed, 1 other |
| Linked publications | 17 (5 Cochrane reviews, 5 clinical trial publications, 4 meta-analyses, 3 systematic reviews) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | Open Targets, ChEMBL |
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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT03818399 | Virginia Opioid Overdose Treatment InitiatVE 2019 | terminated | Phase 3 | 19 |
| NCT03766893 | Medication Maintenance Therapy in Community Pharmacy Settings 2018 | completed | Early Phase 1 | 11 |
| NCT05944133 | Health Insurance Instability and Mortality Among Patients Receiving Bup Tx for OUD 2023 | active, not recruiting | Not applicable | 27,257 |
| NCT04449744 | Evaluating Adaptive Dispenser Initiation Protocols for MySafeRx During Post-detox Buprenorphine Treatment- a Pilot Study 2020 | completed | Not applicable | 19 |
| NCT03976258 | Effect of Heroin Use on Immune Activation and Cardiovascular Risk in HIV 2017 | completed | Not applicable | 190 |
| NCT07631598 | Buprenorphine Implementation at Syringe Service Programs to Reduce Overdoses 2026 | not yet recruiting | Not applicable | 512 |
| NCT06999811 | Technology-Enhanced Therapy vs. Medication Monitoring for Buprenorphine Retention in Pregnant Persons 2025 | recruiting | Not applicable | 37 |
| NCT05534815 | Long-Term Treatment of Opioid Use Disorder 2023 | recruiting | Not applicable | 225 |
Published literature
- Clinical trial publication Adjunctive Psychosocial Interventions and Opioid Abstinence Among Patients Receiving Buprenorphine: A Randomized Clinical TrialLent MR, Hurstak EE, Lynch KG et al. · JAMA network open · 2026 · PMID 42334848
- Clinical trial publication Differential Impacts of Methadone and Buprenorphine/Naloxone on Pain-Related Outcomes Among People With Non-Heroin Opioid Use Disorder: Secondary Analyses From a Pragmatic Canadian Multisite TrialLyman K, Choi J, Jutras-Aswad D et al. · Drug and alcohol review · 2026 · PMID 42313747
- Clinical trial publication Investigating craving as an indicator of early response to buprenorphine treatment among adults with opioid use disorderVotaw VR, London Z, Bailey AJ et al. · Journal of consulting and clinical psychology · 2026 · PMID 42241061
- Clinical trial publication Sex-based effectiveness in buprenorphine/naloxone and methadone treatment for opioid use disorder: Findings from the OPTIMA trialMcAnulty C, Bastien G, Pek C et al. · Drug and alcohol dependence · 2026 · PMID 42161037
- Clinical trial publication "It was good because they have a relationship with us": A qualitative study on low-threshold buprenorphine treatment at syringe services programsMcGill E, Hayes BT, López-Castro T et al. · Journal of substance use and addiction treatment · 2026 · PMID 42155653
- Cochrane review Quantitative sensory testing of pain in persons with opioid use disorder on opioid agonist treatment: a scoping reviewOliveira D, Costa GPA, Fontenele R et al. · Pain medicine (Malden, Mass.) · 2026 · PMID 40990827
- Cochrane review Buprenorphine-naloxone vs methadone for opioid use disorder: a systematic review and meta-analysis of randomized clinical trialsPereira da Silva AM, de Bastos Maximiano ML, Cabeça LS et al. · Journal of addictive diseases · 2026 · PMID 40536198
- Meta-analysis Effectiveness and safety of therapies for patients with opioid use disorder: a systematic review and network meta-analysisKabra M, Srivastava T, Gautam R et al. · Journal of comparative effectiveness research · 2026 · PMID 41521864
- Meta-analysis Buprenorphine-based treatments outcomes in pregnant opioid-dependent women: A systematic review and meta-analysisAkbarzadeh F, Ebrahimi A · Addiction (Abingdon, England) · 2026 · PMID 41345707
- Systematic review Systematic review of real-world data associated with opioid scheduling and nonmedical useVosburg SK, Dailey-Govoni T, Green JL · Journal of opioid management · 2026 · PMID 41774073
- Systematic review Pharmacological treatment strategies to manage precipitated withdrawal following the administration of buprenorphine in opioid use disorder: A systematic reviewRoberts E, Kalk N, Strang J · Addiction (Abingdon, England) · 2026 · PMID 41571617
- Cochrane review Acute Pain Management in People With Opioid Use Disorder : A Systematic ReviewBuonora MJ, Mackey K, Khalid L et al. · Annals of internal medicine · 2025 · PMID 40096692
- Cochrane review Buprenorphine-naloxone versus buprenorphine for opioid use disorder during pregnancy: A systematic review and meta-analysisde Lima FR, Molino GOG, Gallo Ruelas M et al. · Drug and alcohol dependence · 2025 · PMID 40073807
- Cochrane review Buprenorphine's Effect on the Human Immune System and InflammationShin SD, Branning R, McGinnis M et al. · Clinical and translational science · 2025 · PMID 40065582
- Meta-analysis Oral and injectable opioid agonist treatments for people who use street opioids: a systematic literature review and network meta-analysisBansback N, Tam ACT, Palis H et al. · BMC public health · 2025 · PMID 40885969
- Meta-analysis The association between mental disorders and treatment retention among people with opioid use disorder receiving opioid agonist treatment: A systematic review and meta-analysisTran LT, McKetin R, Clark B et al. · Drug and alcohol dependence · 2025 · PMID 40582093
- Systematic review Low-Dose Buprenorphine Initiation for Opioid Agonist Therapy in Patients with Opioid Use Disorder: A Dutch Consensus PaperVeldman SE, Lijftogt N, Knuijver T et al. · European addiction research · 2025 · PMID 41129411
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Buprenorphine approved for Opioid Use Disorder?
Buprenorphine has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Opioid Use Disorder would be drug repurposing rather than first-in-human development. This does not mean it is approved for Opioid Use Disorder. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Buprenorphine in clinical trials for Opioid Use Disorder?
ClinicalTrials.gov lists 8 registered trials linking Buprenorphine to Opioid Use Disorder: 2 are currently recruiting; 2 are active or not yet recruiting; 3 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT03818399). The largest enrolment is 27257 participants (NCT05944133). Registration activity spans 2017 to 2026.
What does the evidence show for Buprenorphine in Opioid Use Disorder?
Buprenorphine 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 A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL. 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.