At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1b/2 Randomized, Double-Blind, Placebo-Controlled, Ascending-Dose Study of BXCL501 to Treat Symptoms of Acute Opioid Withdrawal in Patients With Opioid Use Disorder Who Are Physically Dependent on Opioids
In Brief
A Phase 1 clinical trial evaluating Dexmedetomidine and Placebo for Opioid Withdrawal. Completed, enrolled 225 participants across 3 sites.
Detailed Summary
This Phase 1b/2 inpatient study assessed the safety, pharmacokinetics, and early signs of efficacy of escalating doses of BXCL501 versus placebo following discontinuation of morphine maintenance. The opioid (morphine) maintenance phase (Phase 1b) included Days 1-5; the randomized BXCL501/placebo phase (Phase 2) included Days 6-12. The randomized phase was followed by 2 sequential days, Days 13 and 14, utilizing treatment of BXCL501-placebo sublingual films and morphine-placebo capsules for all subjects who remained in the study.
Study Details
Timeline
Arms & Interventions
Sublingual film containing 30 Micrograms Dexmedetomidine or Placebo Sublingual film
Sublingual film containing 60 Micrograms Dexmedetomidine or Placebo Sublingual film
Sublingual film containing 90 Micrograms Dexmedetomidine or Placebo Sublingual film
Sublingual film containing 120 Micrograms Dexmedetomidine or Placebo Sublingual film
Sublingual film containing 180 Micrograms Dexmedetomidine or Placebo Sublingual film
Sublingual film containing 240 Micrograms Dexmedetomidine or Placebo Sublingual film
Interventions
Sublingual Film of Dexmedetomidine
Sublingual Placebo film