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First received: July 18, 2023

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

Study Status: Completed

Recruit Status: RECRUITING

Condition: Opioid Withdrawal (Disorder)

Study Type: INTERVENTIONAL


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

Brief 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…

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