At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 382 enrolled
Drug / intervention
Buprenorphine/naloxone Film Strip +1 moredrug
Likely dose
Buprenorphine/naloxone Film Strip 1 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Buprenorphine/naloxone Film Strip for Opioid-Related Disorders. Completed, enrolled 382 participants across 3 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpioid-Related Disorders
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2008
First PostedMar 2008
Primary CompletionOct 2008
TodayJul 2026
First PostedMar 21, 2008
Enrollment StartFeb 1, 2008
Primary CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 18.3 years ago
Interventions
Buprenorphine/naloxone Film Stripdrug
Buprenorphine/naloxone dosed between 4/1 mg to 32/8 mg once a day for 12 weeks by sublingual route
Buprenorphine/naloxone Film Stripdrug
Buprenorphine/naloxone dosed between 4/1 mg to 32/8 mg once a day for 12 weeks by buccal route