NCT06047834

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

A Phase 2, Open-Label, Randomized, Controlled, Dose Cohort, Pharmacokinetic and Safety Study of Oral Lofexidine in Neonates Experiencing Opioid Withdrawal Due to Intrauterine Exposure to Opioids

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: BioCorRx Pharmaceuticals Inc · Academic / Other
• Sex: All
• Age: 0 Hours – 6 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Opioid Withdrawal (Disorder)

Interventions

Type	Name	Description
DRUG	Standard of Care with Lofexidine	Participants will be randomized 3:1 to treatment with standard of care with or without lofexidine. Subjects randomized to standard of care with lofexidine will be sequentially assigned to 1 of 3 dose levels: Dose 1 (32 μg/kg/day, administered as 4 μg/kg/day q3h), Dose 2 (20 μg/kg/day, administered as 5 μg/kg/day q6h), or Dose 3 (16 μg/kg/day to 24 μg/kg/day administered q6h, with the final daily dose level to be decided based on data collected in participants receiving Dose 2).
OTHER	Standard of Care without Lofexidine	Participants will be randomized 3:1 to treatment with standard of care with or without lofexidine. Subjects randomized to standard of care without lofexidine wilt receive non-pharmacologic measures and morphine when indicated.

Timeline

• Start date: 2023-10-02
• Primary completion: 2025-05-11
• Completion: 2026-10-01
• First posted: 2023-09-21
• Last updated: 2025-10-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study