Lofexidine for Neonatal Opioid Withdrawal
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if participants must stop taking their current medications. However, infants who have already received treatment for NOWS with certain medications like morphine, methadone, buprenorphine, clonidine, or phenobarbital before screening are excluded from the study.
What data supports the effectiveness of the drug Lofexidine for treating neonatal opioid withdrawal?
Is Lofexidine safe for humans?
How is the drug Lofexidine unique for treating neonatal opioid withdrawal?
Lofexidine is unique because it is a non-opioid drug that helps manage withdrawal symptoms by reducing the body's stress response (sympathetic outflow) without reinforcing opioid dependence. It works by targeting specific receptors in the body, making it different from other treatments that may involve opioids or have less specificity.12457
Eligibility Criteria
This trial is for newborns under 7 days old, born at or after 35 weeks of gestation, weighing at least 1.8 kg, who are experiencing opioid withdrawal due to their mother's opioid use during pregnancy. The baby must be able to take oral medication and show specific signs of withdrawal. Babies with certain health issues like low heart rate, seizures, low platelet count, or those already treated for withdrawal are excluded.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive standard of care and varying doses of Lofexidine for the treatment of opioid withdrawal symptoms
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Lofexidine
Lofexidine is already approved in United States, United Kingdom for the following indications:
- Mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults
- Management of opioid withdrawal symptoms
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Who Is Running the Clinical Trial?
USWM, LLC (dba US WorldMeds)
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Collaborator