Safety and Tolerability of Buprenorphine/Naloxone Film Strips

Opioid-Related Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00640835
• Other study ID #: RB-US-07-0001
• Status: Completed
• Phase: Phase 2
• First received: March 14, 2008
• Last updated: November 6, 2012
• Start date: February 2008
• Est. completion date: October 2008

Study information

• Verified date: October 2008
• Source: Indivior Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 382
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Opioid-Related Disorders

Intervention

Drug:
• Buprenorphine/naloxone Film Strip
Buprenorphine/naloxone dosed between 4/1 mg to 32/8 mg once a day for 12 weeks by sublingual route
• Buprenorphine/naloxone Film Strip
Buprenorphine/naloxone dosed between 4/1 mg to 32/8 mg once a day for 12 weeks by buccal route

Locations

Country	Name	City	State
United States	Parkway Medical Center	Birmingham	Alabama
United States	Winston Technology Research LLC	Haleyville	Alabama
United States	Beeches Family Medicine	Jacksonville Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Indivior Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes