Summary
Buprenorphine Hydrochloride 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 Hydrochloride 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Opioid Use Disorder: 2 are currently recruiting; 2 are active or not yet recruiting; 3 have completed; 1 is terminated, withdrawn, suspended or of unknown status.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 5 publications for this pair: 5 clinical trial publications. Publication years run from 2014 to 2018. These are primary trial reports rather than syntheses, so results have not yet been pooled or graded independently.
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 | 51.5 (trials 21.5, literature 10.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 2 recruiting, 2 active / not yet recruiting, 3 completed, 1 other |
| Linked publications | 5 (5 clinical trial publications) |
| 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 Weekly and Monthly Subcutaneous Buprenorphine Depot Formulations vs Daily Sublingual Buprenorphine With Naloxone for Treatment of Opioid Use Disorder: A Randomized Clinical TrialLofwall MR, Walsh SL, Nunes EV et al. · JAMA internal medicine · 2018 · PMID 29799968
- Clinical trial publication Effectiveness of Injectable Extended-Release Naltrexone vs Daily Buprenorphine-Naloxone for Opioid Dependence: A Randomized Clinical Noninferiority TrialTanum L, Solli KK, Latif ZE et al. · JAMA psychiatry · 2017 · PMID 29049469
- Clinical trial publication Efficacy of Tramadol Extended-Release for Opioid Withdrawal: A Randomized Clinical TrialDunn KE, Tompkins DA, Bigelow GE et al. · JAMA psychiatry · 2017 · PMID 28700791
- Clinical trial publication Effect of Buprenorphine Implants on Illicit Opioid Use Among Abstinent Adults With Opioid Dependence Treated With Sublingual Buprenorphine: A Randomized Clinical TrialRosenthal RN, Lofwall MR, Kim S et al. · JAMA · 2016 · PMID 27434441
- Clinical trial publication Primary care-based buprenorphine taper vs maintenance therapy for prescription opioid dependence: a randomized clinical trialFiellin DA, Schottenfeld RS, Cutter CJ et al. · JAMA internal medicine · 2014 · PMID 25330017
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 Hydrochloride approved for Opioid Use Disorder?
Buprenorphine Hydrochloride 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 Hydrochloride in clinical trials for Opioid Use Disorder?
ClinicalTrials.gov lists 8 registered trials linking Buprenorphine Hydrochloride 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 Hydrochloride in Opioid Use Disorder?
Buprenorphine Hydrochloride has 3 completed trials and 5 linked publications for Opioid Use Disorder. Completed trials may or may not have posted results; follow the NCT links to check. 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.