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

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).

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.