Summary
Methadone 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linking Methadone Hydrochloride to Opioid Use Disorder: 2 are currently recruiting; 5 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 2 (NCT05529927). The largest enrolment is 400 participants (NCT06291090). Registration activity spans 2013 to 2026. The literature layer holds 7 publications for this pair: 1 meta-analysis, 1 randomised controlled trial publication and 5 clinical trial publications. Publication years run from 1998 to 2013. 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 | 58.0 (trials 21.0, literature 17.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 2 recruiting, 0 active / not yet recruiting, 5 completed, 1 other |
| Linked publications | 7 (5 clinical trial publications, 1 meta-analysis, 1 randomised controlled 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT05529927 | Efficacy and Safety of Sustained-release Dexamphetamine in Patients With Moderate to Severe Cocaine Use Disorder 2026 | recruiting | Phase 2 | 204 |
| NCT05924022 | Hyperbaric Oxygen Treatment (HBOT) During Methadone Tapering 2023 | completed | Phase 1 | 25 |
| NCT03976258 | Effect of Heroin Use on Immune Activation and Cardiovascular Risk in HIV 2017 | completed | Not applicable | 190 |
| NCT06291090 | A Multi-site Intervention to Expand Hospital Based OUD Treatment Provision 2023 | completed | Not applicable | 400 |
| NCT03065049 | Transforming Recovery Through Exercise and Community 2016 | completed | Not applicable | 81 |
| NCT01847729 | OPAL: "Opiates and PhArmacoLogy" 2013 | completed | Not applicable | 263 |
| NCT05534815 | Long-Term Treatment of Opioid Use Disorder 2023 | recruiting | Not applicable | 225 |
| NCT05341219 | Light Needle for Opioid Use Disorder 2022 | status unknown | Not applicable | 100 |
Published literature
- Clinical trial publication Medically assisted recovery from opiate dependence within the context of the UK drug strategy: methadone and Suboxone (buprenorphine-naloxone) patients comparedMcKeganey N, Russell C, Cockayne L · Journal of substance abuse treatment · 2013 · PMID 22703715
- Clinical trial publication Six-month trial of bupropion with contingency management for cocaine dependence in a methadone-maintained populationPoling J, Oliveto A, Petry N et al. · Archives of general psychiatry · 2006 · PMID 16461866
- Clinical trial publication Effects of lower-cost incentives on stimulant abstinence in methadone maintenance treatment: a National Drug Abuse Treatment Clinical Trials Network studyPeirce JM, Petry NM, Stitzer ML et al. · Archives of general psychiatry · 2006 · PMID 16461864
- Clinical trial publication A randomized controlled trial of interim methadone maintenanceSchwartz RP, Highfield DA, Jaffe JH et al. · Archives of general psychiatry · 2006 · PMID 16389204
- Randomized controlled trial Methadone dose increase and abstinence reinforcement for treatment of continued heroin use during methadone maintenancePreston KL, Umbricht A, Epstein DH · Archives of general psychiatry · 2000 · PMID 10768702
- Clinical trial publication Desipramine in opioid-dependent cocaine abusers maintained on buprenorphine vs methadoneOliveto AH, Feingold A, Schottenfeld R et al. · Archives of general psychiatry · 1999 · PMID 12884887
- Meta-analysis The efficacy of methadone maintenance interventions in reducing illicit opiate use, HIV risk behavior and criminality: a meta-analysisMarsch LA · Addiction (Abingdon, England) · 1998 · PMID 9684390
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 Methadone Hydrochloride approved for Opioid Use Disorder?
Methadone 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 Methadone Hydrochloride in clinical trials for Opioid Use Disorder?
ClinicalTrials.gov lists 8 registered trials linking Methadone Hydrochloride to Opioid Use Disorder: 2 are currently recruiting; 5 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 2 (NCT05529927). The largest enrolment is 400 participants (NCT06291090). Registration activity spans 2013 to 2026.
What does the evidence show for Methadone Hydrochloride in Opioid Use Disorder?
Methadone Hydrochloride 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.