Clinical Trial

Pharmacokinetic and Safety Study of Oral Lofexidine in Neonates Experiencing Opioid Withdrawal Due to Intrauterine Exposure to Opioids

Active, Not Recruiting Phase 2
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Summary
A randomized, open-label, controlled, ascending dose cohort, PK, and safety study assessing standard of care (i.e., non-pharmacologic measures and morphine when indicated) with or without lofexidine for the treatment of opioid withdrawal symptoms in neonates due to intrauterine exposure to opioids, described as neonatal opioid withdrawal syndrome (NOWS) or neonatal abstinence syndrome (NAS). This study has been designed to assess the pharmacokinetics (PK) and safety of the lofexidine in neonates experiencing NOWS. The effectiveness of lofexidine on the severity of NOWS will also be evaluated. Results from this study will be used to support dosing recommendations in neonates and to inform further studies in the pediatric patient population.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2023-09-14; most recent amendment 2026-06-17.
Status change: Recruiting → Active, Not Recruiting 2025-06-17
Status change: Not Yet Recruiting → Recruiting 2023-10-16
Trial Details
NCT Number NCT06047834
Lead Sponsor BioCorRx Pharmaceuticals Inc
Collaborators: National Institute on Drug Abuse (NIDA)
Conditions Opioid Withdrawal (Disorder)
Enrollment 24 participants
Start Date 2023-10-02
Primary Completion 2025-05-11 (estimated)
Study Completion 2026-10 (estimated)
Updated on ClinicalTrials.gov 2025-10-01