New sublingual film could make opioid withdrawal less miserable

NCT ID NCT05712707

Ongoing Symptom relief Sponsor: New York State Psychiatric Institute Source: ClinicalTrials.gov ↗

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

Summary

This study tests a new sublingual film called BXCL501 (dexmedetomidine) to reduce the unpleasant symptoms of opioid withdrawal, like anxiety, muscle pain, and nausea. About 160 adults with opioid use disorder will receive the drug, a placebo, or an existing medication (lofexidine) during a 7-day inpatient stay. The goal is to see if BXCL501 is safer and works better than current options.

What this could mean

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

Active substance: BXCL501 (dexmedetomidine sublingual film)
What this could lead to: If successful, this could offer a safer, non-opioid option to manage withdrawal symptoms and help people start treatment for opioid use disorder.
What could go wrong: This is an early-phase trial with only 160 participants, and one site is paused. The drug may not prove safer or more effective than existing options like lofexidine.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

opiate dependence substance withdrawal syndrome

As listed by the trial registrant

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

OPIOID WITHDRAWAL OPIOID-USE DISORDER

Contacts and locations

Locations

CenExel HRI

Marlton, New Jersey, 08053, United States
Clinilabs

Eatontown, New Jersey, 07724, United States
New York State Psychiatric Institute

New York, New York, 10032, United States
Yale University

New Haven, Connecticut, 06519, United States

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