Summary
Naloxone Hydrochloride Dihydrate 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 2 registered trials linking Naloxone Hydrochloride Dihydrate to Opioid Use Disorder: 1 is currently recruiting; 1 has completed. The most advanced is Phase 4 (NCT07439549). The largest enrolment is 47 participants (NCT02559973). Registration activity spans 2015 to 2026. The literature layer holds 1 publication for this pair: 1 clinical trial publication. The dated items are from 2013. 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 | 30.0 (trials 8.0, literature 2.0, tier 15, approved bonus 5.0) |
| Registered trials | 2 total: 1 recruiting, 0 active / not yet recruiting, 1 completed, 0 other |
| Linked publications | 1 (1 clinical trial publication) |
| 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT07439549 | Symptom-Inhibited Naloxone Induction (SINI) for Buprenorphine Initiation: A Feasibility Trial 2026 | recruiting | Phase 4 | 12 |
| NCT02559973 | Pharmacokinetics, Safety, and Tolerability of Depot Buprenorphine at Three Different Molecular Weights in Treatment-Seeking Subjects With Opioid Use Disorder 2015 | completed | Phase 1 | 47 |
Published literature
- Clinical trial publication A randomized, double-blind evaluation of buprenorphine taper duration in primary prescription opioid abusersSigmon SC, Dunn KE, Saulsgiver K et al. · JAMA psychiatry · 2013 · PMID 24153411
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 Naloxone Hydrochloride Dihydrate approved for Opioid Use Disorder?
Naloxone Hydrochloride Dihydrate 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 Naloxone Hydrochloride Dihydrate in clinical trials for Opioid Use Disorder?
ClinicalTrials.gov lists 2 registered trials linking Naloxone Hydrochloride Dihydrate to Opioid Use Disorder: 1 is currently recruiting; 1 has completed. The most advanced is Phase 4 (NCT07439549). The largest enrolment is 47 participants (NCT02559973). Registration activity spans 2015 to 2026.
What does the evidence show for Naloxone Hydrochloride Dihydrate in Opioid Use Disorder?
Naloxone Hydrochloride Dihydrate has 1 completed trial and 1 linked publication 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.