Safety and Tolerability of Buprenorphine/Naloxone Film Strips

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Indivior Inc.
• Treatments: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone

Criteria

Inclusion Criteria:

Subjects must:

• Be 18-to-65 years of age, inclusive.

• Have a diagnosis of opioid dependence by medical history according to DSM-IV-TR criteria.

• Be on stable dose of 4 to 32 mg (expressed as the buprenorphine component)daily of Suboxone for at least 30 days.

• If female, have a negative pregnancy test during screening and agree to use an acceptable method of birth control which may include:

Exclusion Criteria:

Subjects must not:

• Have participated in an experimental drug or device study within the last 30 days.

• If female, be breast feeding or lactating.

• Have any medical condition that in the opinion of the physician investigator would preclude the subject from completing the study.

• Have a clinically significant abnormal finding (in the opinion of the Investigator) on oral cavity exam (e.g., active mouth ulcers).

• Have any piercing of the tongue or mouth within 30 days prior to the first dose of study medication.