NCT00640835

Safety and Tolerability of Buprenorphine/Naloxone Film Strips

A Phase 2 Multi-Center Open-label Study to Assess the Safety and Tolerability of a Buprenorphine/Naloxone Film Strip Administered by the Sublingual and Buccal Routes

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 382 (actual)
• Sponsor: Indivior Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety and tolerability on the oral mucosa of buprenorphine/naloxone film strips administered either sublingually or buccally daily for 12 weeks in opioid dependent individuals who are already on a stable regimen of buprenorphine/naloxone.

Detailed description

Buprenorphine and naloxone soluble film was developed as an alternative dosage form to Suboxone (buprenorphine and naloxone) sublingual tablets and was evaluated for both sublingual and buccal administration. The soluble film dosage is expected to provide the following enhancements and potential advantages over the current Suboxone (buprenorphine and naloxone) product: * mitigation against unintentional pediatric exposure by providing child-resistant packaging in unit dose format. * improvement in subject convenience and compliance by ensuring rapid disintegration. * protection against diversion by providing a dosage form that is very difficult for the subject to remove from the sublingual or buccal mucosa after administration. This provides assurance to the caregiver that the dose has actually been taken appropriately in a supervised setting. * provision of a unit dose product format for hospital and institutional use. * decreased product damage during shipping as compared to Suboxone tablets.

Conditions

• Opioid-Related Disorders

Interventions

Type	Name	Description
DRUG	Buprenorphine/naloxone Film Strip	Buprenorphine/naloxone dosed between 4/1 mg to 32/8 mg once a day for 12 weeks by sublingual route
DRUG	Buprenorphine/naloxone Film Strip	Buprenorphine/naloxone dosed between 4/1 mg to 32/8 mg once a day for 12 weeks by buccal route

Timeline

• Start date: 2008-02-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2008-03-21
• Last updated: 2012-11-12
• Results posted: 2010-10-26

Locations

3 sites across 1 country: United States