Active — Not RecruitingPhase 2

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

United States24 participantsStarted 2023-10-02

Plain-language 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.

Who can participate

Age range0 Hours – 6 Days

SexALL

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Inclusion criteria

✓. Written informed consent obtained from the patient's parent or legally authorized representative(s) (LAR)/guardian(s) in accordance with local laws and Institutional Review Board (IRB) requirements.
✓. Infants \<7 days of age at the time of randomization.
✓. Gestational age ≥35 weeks at birth.
✓. Minimum weight ≥1.8 kg at birth.
✓. Infant's mother is ≥18 years of age.
✓. Intrauterine opiate exposure expected to contribute to NOWS symptoms, as determined by the Principal Investigator and supported by at least one of the following:
✓. Maternal history of opiate use during pregnancy as confirmed by diagnosis of opioid use disorder (OUD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), treatment for OUD, treatment with an opioid prescribed by a licensed physician or health care worker, documentation of opiate use in maternal medical record, and/or maternal self-reported opiate use;
✓. Positive maternal urine opiate screen during pregnancy or delivery; or

Exclusion criteria

What they're measuring

Plasma concentrations following single dose and repeated lofexidine administration in participants

Timeframe: Day 1 through Day 7

Trial details

NCT IDNCT06047834

SponsorBioCorRx Pharmaceuticals Inc

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-11

View on ClinicalTrials.gov More Opioid Withdrawal (Disorder) trials