Summary
Levomethadyl Acetate 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 1 registered trial linking Levomethadyl Acetate to Opioid Use Disorder: 1 has completed. The most advanced is Phase 2 (NCT00158288). It plans or enrolled 140 participants. Registered activity dates to 1997. The literature layer holds 5 publications for this pair: 1 Cochrane review and 4 clinical trial publications. Publication years run from 1997 to 2015. 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 | 36.5 (trials 3.5, literature 13.0, tier 15, approved bonus 5.0) |
| Registered trials | 1 total: 0 recruiting, 0 active / not yet recruiting, 1 completed, 0 other |
| Linked publications | 5 (4 clinical trial publications, 1 Cochrane review) |
| 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT00158288 | The Efficacy of Methadyl Acetate (LAAM) and Contingency Management Procedures for Treating Dual Opioid and Cocaine Abuse - 1 1997 | completed | Phase 2 | 140 |
Published literature
- Cochrane review The impact of chronic pain on opioid addiction treatment: a systematic review protocolDennis BB, Bawor M, Paul J et al. · Systematic reviews · 2015 · PMID 25927914
- Clinical trial publication HIV risk behaviors during pharmacologic treatment for opioid dependence: a comparison of levomethadyl acetate [corrected] buprenorphine, and methadoneLott DC, Strain EC, Brooner RK et al. · Journal of substance abuse treatment · 2006 · PMID 16919747
- Clinical trial publication A comparison of levomethadyl acetate, buprenorphine, and methadone for opioid dependenceJohnson RE, Chutuape MA, Strain EC et al. · The New England journal of medicine · 2000 · PMID 11058673
- Clinical trial publication Induction with levomethadyl acetate: safety and efficacyJones HE, Strain EC, Bigelow GE et al. · Archives of general psychiatry · 1998 · PMID 9707384
- Clinical trial publication Dose-related efficacy of levomethadyl acetate for treatment of opioid dependence. A randomized clinical trialEissenberg T, Bigelow GE, Strain EC et al. · JAMA · 1997 · PMID 9200635
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 Levomethadyl Acetate approved for Opioid Use Disorder?
Levomethadyl Acetate 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 Levomethadyl Acetate in clinical trials for Opioid Use Disorder?
ClinicalTrials.gov lists 1 registered trial linking Levomethadyl Acetate to Opioid Use Disorder: 1 has completed. The most advanced is Phase 2 (NCT00158288). It plans or enrolled 140 participants. Registered activity dates to 1997.
What does the evidence show for Levomethadyl Acetate in Opioid Use Disorder?
Levomethadyl Acetate 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.