Safety and Tolerability of Buprenorphine/Naloxone Film Strips
Information source: Reckitt Benckiser Pharmaceuticals, Inc
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Opioid-Related Disorders
Intervention: Buprenorphine/naloxone Film Strip (Drug); Buprenorphine/naloxone Film Strip (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Reckitt Benckiser Pharmaceuticals, Inc Official(s) and/or principal investigator(s):
Donald R. Jasinski, MD, Principal Investigator, Affiliation: Johns Hopkins University
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.
Clinical Details
Official title: 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
Study design: Treatment, Randomized, Open Label, Parallel Assignment, Safety Study
Primary outcome: Severity and frequency of oral mucosal adverse events
Secondary outcome: Adverse events
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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.
Locations and Contacts
Parkway Medical Center, Birmingham, Alabama 35215, United States
Winston Technology Research LLC, Haleyville, Alabama 35565, United States
Beeches Family Medicine, Jacksonville Beach, Florida 32250, United States
Johns Hopkins Bayview Medical Center, Baltimore, Maryland 21224, United States
Additional Information
Starting date: March 2008
Last updated: April 21, 2008
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