Phase 2
N=382
Safety and Tolerability of Buprenorphine/Naloxone Film Strips
Opioid-Related Disorders
Bottom Line
View on ClinicalTrials.gov: NCT00640835 ↗Enrolled (actual)
382
Serious AEs
1.6%
Results posted
Oct 2010
Primary outcome: Primary: Number of Subjects With Treatment-emergent Adverse Events Associated With the Oral Cavity. — 11; 16 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Buprenorphine/naloxone Film Strip (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Indivior Inc.
- Primary completion
- Oct 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Treatment-emergent Adverse Events Associated With the Oral Cavity. |
11; 16 | — |
| PRIMARY Number of Subjects With Mild, Moderate or Severe Treatment-emergent Adverse Events Associated With the Oral Cavity |
9; 12; 2; 3; 0; 1 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00640835). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.