Could a simple drug ease withdrawal in Opioid-Exposed newborns?

NCT ID NCT06047834

Ongoing Symptom relief Sponsor: BioCorRx Pharmaceuticals Inc Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests an oral drug called lofexidine in newborns who are going through opioid withdrawal because their mothers used opioids during pregnancy. The drug is added to standard care (which includes non-drug support and morphine when needed). The goal is to see if lofexidine is safe, how the baby's body processes it, and whether it helps reduce withdrawal symptoms. About 24 newborns will take part, and the results will guide future research.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: lofexidine (oral granules)
What this could lead to: If it works, this could provide a safer, more effective way to treat opioid withdrawal in newborns, reducing their hospital stay and suffering.
What could go wrong: This is a small, early-phase trial with only 24 babies, so results may not apply broadly. The drug's safety and effectiveness in newborns are still uncertain.

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Conditions

The condition(s) this trial relates to.

neonatal abstinence syndrome substance withdrawal syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

OPIOID WITHDRAWAL (DISORDER)

Contacts and locations

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Locations

Marshall Health

Huntington, West Virginia, 25701, United States

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