Safety and Tolerability of Buprenorphine/Naloxone Film Strips

Study Overview
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Brief Summary
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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.

Detailed Description
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Buprenorphine and naloxone soluble film was developed as an alternative dosage form to Suboxone (buprenorphine and naloxone) sublingual tablets and was evaluated for both sublingual and buccal administration. The soluble film dosage is expected to provide the following enhancements and potential advantages over the current Suboxone (buprenorphine and naloxone) product: mitigation against unintentional pediatric exposure by providing child-resistant packaging in unit dose format. improvement in subject convenience and compliance by ensuring rapid disintegration. protection against diversion by providing a dosage form that is very difficult for the subject to remove from the sublingual or buccal mucosa after administration. This provides assurance to the caregiver that the dose has actually been taken appropriately in a supervised setting. provision of a unit dose product format for hospital and institutional use. decreased product damage during shipping as compared to Suboxone tablets.

Official Title
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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

Conditions
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Opioid-Related Disorders

Intervention / Treatment
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* Drug: Buprenorphine/naloxone Film Strip
* Drug: Buprenorphine/naloxone Film Strip


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sublingual administration<br>Buprenorphine/naloxone film strip administered sublingually | Drug: Buprenorphine/naloxone Film Strip<br>* Buprenorphine/naloxone dosed between 4/1 mg to 32/8 mg once a day for 12 weeks by sublingual route<br>|
| Experimental: Buccal administration<br>Buprenorphine/naloxone film strip administered buccally | Drug: Buprenorphine/naloxone Film Strip<br>* Buprenorphine/naloxone dosed between 4/1 mg to 32/8 mg once a day for 12 weeks by buccal route<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Treatment-emergent Adverse Events Associated With the Oral Cavity. | Safety and tolerability were evaluated during the 12-week Treatment Phase by oral cavity examination and assessment. Oral mucosa was graded as follows: Grade 0: Normal mucosa Grade 1: Localized mucosal erythema and/or irritation without ulceration Grade 2: Erythema and/or irritation and induration without ulceration Grade 3: Ulceration, with or without any other combination of signs | 12 weeks | 
| Number of Subjects With Mild, Moderate or Severe Treatment-emergent Adverse Events Associated With the Oral Cavity | Safety and tolerability were evaluated during the 12-week Treatment Phase by oral cavity examination and assessment. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Opioid dependence