Status:
COMPLETED
Safety and Tolerability of Buprenorphine/Naloxone Film Strips
Lead Sponsor:
Indivior Inc.
Conditions:
Opioid-Related Disorders
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 indivi...
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 adminis...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
382 Patients enrolled
Trial Details
Trial ID
NCT00640835
Start Date
February 1 2008
End Date
October 1 2008
Last Update
November 12 2012
Active Locations (3)
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1
Parkway Medical Center
Birmingham, Alabama, United States, 35215
2
Winston Technology Research LLC
Haleyville, Alabama, United States, 35565
3
Beeches Family Medicine
Jacksonville Beach, Florida, United States, 32250