NCT02516436

The Safety of Using Buprenorphine With Naloxone in a Buccal Film to Initiate Treatment of Opioid Dependent Subjects

A Randomized, Double-blind, Active Control Evaluation of the Safety of BioErodible MucoAdhesive (BEMA®) Buprenorphine NX for Buprenorphine Induction of Opioid Dependent Subjects

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: BioDelivery Sciences International · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

A randomized, double blind, active controlled study in approximately 40 opioid dependent subjects. Study duration is up to five days and includes a maximum of 3 days confinement in the clinic. Opioid dependent subjects who provide informed consent meet all entry criteria are eligible for enrollment into the study.

Detailed description

A randomized, double blind, active controlled study in approximately 40 opioid dependent subjects. The study includes a Screening period of up to 3 days and a 2-day, double blind induction phase (subjects confined to the clinic). Screening and the first day of treatment (Day 1) may occur on the same day or Screening may occur up to 3 days prior to Day 1. Opioid dependent subjects who provide informed consent at the Screening visit; have a Clinical Opiate Withdrawal Scale (COWS) total score ≥12; and meet other entry criteria are eligible for enrollment into the study. Subjects will be confined to the clinic beginning on Day 1 (optional confinement on Day -1) and will remain there for up to 48 hours after administration of the first study drug dose.

Conditions

• Opioid Dependence

Interventions

Type	Name	Description
DRUG	BEMA Buprenorphine NX	Buprenorphine with naloxone
DRUG	Buprenorphine	Buprenorphine

Timeline

• Primary completion: 2017-05-01
• Completion: 2017-05-01
• First posted: 2015-08-05
• Last updated: 2017-05-04

Locations

3 sites across 1 country: United States