Sublingual Dexmedetomidine for Treating Opioid Withdrawal
Status:
Not yet recruiting
Trial end date:
2025-04-30
Target enrollment:
Participant gender:
Summary
A major challenge to seeking treatment for opioid use disorder (OUD) is the withdrawal
symptoms associated with cessation of opioid use. The signs and symptoms of the opioid
withdrawal include irritability, anxiety, muscular and abdominal pains, chills, nausea,
diarrhea, yawning, runny eyes and nose, sweating, sneezing, weakness, and insomnia. The
current gold standard of treatment involves gradual reduction of the opioid drug dosage
(tapering). However, as all opioids have potential for abuse and require careful dosing due
to side effects (e.g., respiratory depression), a non-opioid medication to facilitate
withdrawal severity would be of great value. Commonly used non-opioid medications like
lofexidine have concerning side effects including sedation and low blood pressure. BioXcel
Therapeutics has developed BXCL501 (dexmedetomidine: sublingual film) to reduce symptoms
associated with opioid withdrawal. Dexmedetomidine is currently used as an intravenous
anesthetic for its anxiety-reducing, sedative, and painrelief properties. The current study
will seek to compare the safety and efficacy of BXCL501 relative to lofexidine and placebo in
subjects with OUD who are physically dependent on opioids. Throughout a 7-day inpatient
withdrawal period, opioid-dependent participants will receive sublingual BXCL501, placebo, or
lofexidine. In comparison to lofexidine, dexmedetomidine is expected to have a superior
safety profile with limited adverse effects on blood pressure and heart rhythm. Three sites
will participate in this study: NYSPI, Clinilabs, Inc., and Yale University, but only NYSPI
and Clinilabs will be governed by the NYSPI IRB.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
New York State Psychiatric Institute
Collaborators:
BioXcel Therapeutics Inc Clinilabs, Inc. National Institute on Drug Abuse (NIDA) Yale University