At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Induction of Opioid-Dependent Individuals Onto Buprenorphine and Buprenorphine/Naloxone
In Brief
A Phase 2 clinical trial evaluating Buprenorphine soluble film, Buprenorphine/naloxone film strip, and 1 other intervention for Opioid-related Disorders. Completed, enrolled 38 participants across 1 site.
Detailed Summary
The purpose of this study is to compare the presence, degree, time course and profile of opioid withdrawal symptoms associated with induction onto new formulations of buprenorphine or buprenorphine/naloxone in persons with active opioid dependence. The primary outcome measure is the severity of withdrawal symptoms measured using the Clinical Opiate Withdrawal Scale (COWS). The primary study hypothesis is that neither drug formulation will precipitate an opioid withdrawal syndrome.
Study Details
Timeline
Interventions
Buprenorphine soluble film strips administered sublingually with doses escalated from 12 mg per day up to 24 mg daily for 5 days of total treatment.
Buprenorphine/naloxone soluble film strips administered sublingually with doses escalated from 12 mg buprenorphine/3 mg naloxone to 24 mg buprenorphine /6 mg naloxone daily for 5 days of total treatment.
Placebo soluble film administered on the same schedule as active treatment to maintain the study blind.