Phase 2
Completed N=382
Safety and Tolerability of Buprenorphine/Naloxone Film Strips
Opioid-Related Disorders
Source: ClinicalTrials.gov NCT00640835 ↗
Enrolled (actual)
382
Serious AEs
1.6%
Results posted
Oct 2010
Primary outcomePrimary: Number of Subjects With Treatment-emergent Adverse Events Associated With the Oral Cavity. — 11; 16 Participants
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.
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 | — |
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. Informational only — not medical advice.