Summary
Lofexidine 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 Lofexidine Hydrochloride to Opioid Use Disorder: 1 is currently recruiting; 1 is active or not yet recruiting; 5 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 2 (NCT03718065). The largest enrolment is 160 participants (NCT05712707). Registration activity spans 2019 to 2025. The literature layer holds 2 publications for this pair: 2 clinical trial publications. Publication years run from 2004 to 2017. 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 | 47.5 (trials 23.5, literature 4.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 1 recruiting, 1 active / not yet recruiting, 5 completed, 1 other |
| Linked publications | 2 (2 clinical trial publications) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | agonist |
| Data sources | DGIdb |
| Linked via biomarker / target | ADRA2C |
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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT04360681 | Lofexidine Combined With Buprenorphine for Reducing Symptoms of PTSD and OU Relapse in Veterans 2021 | completed | Phase 2 | 84 |
| NCT04056182 | Lofexidine for Management of Opioid Withdrawal With XR-NTX Treatment 2019 | completed | Phase 2 | 20 |
| NCT03718065 | Impact of Lofexidine on Stress, Craving and Opioid Use 2019 | completed | Phase 2 | 112 |
| NCT05027919 | Assessing a Clinically-meaningful Opioid Withdrawal Phenotype 2021 | recruiting | Phase 2 | 60 |
| NCT06711640 | A Pharmacokinetic, Safety, and Tolerability Study of LUCEMYRA in the Treatment of Opioid Withdrawal Management in Adolescent Subjects 2025 | withdrawn | Phase 1 | — |
| NCT05712707 | Sublingual Dexmedetomidine for Treating Opioid Withdrawal 2023 | active, not recruiting | PHASE1, PHASE2 | 160 |
| NCT05053503 | Delivering Transcutaneous Auricular Neurostimulation to Improve Relapse Prevention in Opioid Use Disorder 2022 | completed | Not applicable | 108 |
| NCT04325659 | An Innovative Intervention for OUD Treatment 2020 | completed | PHASE2, PHASE3 | 36 |
Published literature
- Clinical trial publication A phase III, randomized, multi-center, double blind, placebo controlled study of safety and efficacy of lofexidine for relief of symptoms in individuals undergoing inpatient opioid withdrawalGorodetzky CW, Walsh SL, Martin PR et al. · Drug and alcohol dependence · 2017 · PMID 28527421
- Clinical trial publication [Clinical observation on effect of modified banxia houpu decoction in treating patients with protracted heroin abstinence syndrome]Huang DB, Yu ZF, Fu L · Zhongguo Zhong xi yi jie he za zhi Zhongguo Zhongxiyi jiehe zazhi = Chinese journal of integrated traditional and Western medicine · 2004 · PMID 15074088
Mechanism and notes
Recorded mechanism or class: agonist.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target ADRA2C. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Lofexidine Hydrochloride approved for Opioid Use Disorder?
Lofexidine 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 Lofexidine Hydrochloride in clinical trials for Opioid Use Disorder?
ClinicalTrials.gov lists 8 registered trials linking Lofexidine Hydrochloride to Opioid Use Disorder: 1 is currently recruiting; 1 is active or not yet recruiting; 5 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 2 (NCT03718065). The largest enrolment is 160 participants (NCT05712707). Registration activity spans 2019 to 2025.
What does the evidence show for Lofexidine Hydrochloride in Opioid Use Disorder?
Lofexidine Hydrochloride has 5 completed trials and 2 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 DGIdb, in this case via the biomarker or target ADRA2C. 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.