Safety and Tolerability of Buprenorphine/Naloxone Film Strips
Completed · Phase 2
Conditions studied: Opioid-Related Disorders
In brief
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.
Key facts
- Study ID
- NCT00640835
- Run by
- Indivior Inc.
- People needed
- 382
- Starts
- 2008-02-01
- Expected to finish
- 2008-10-01
- Last updated by the study team
- 2012-11-12
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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:
You may not qualify if…
- 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.
Where it is running
- Parkway Medical Center — Birmingham, Alabama, United States
- Winston Technology Research LLC — Haleyville, Alabama, United States
- Beeches Family Medicine — Jacksonville Beach, Florida, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.