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Safety and Tolerability of Buprenorphine/Naloxone Film Strips

Primary Purpose

Opioid-Related Disorders

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Buprenorphine/naloxone Film Strip

About this trial

This is an interventional treatment trial for Opioid-Related Disorders focused on measuring Opioid dependence

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Parkway Medical Center
Winston Technology Research LLC
Beeches Family Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Sublingual administration

Buccal administration

Arm Description

Buprenorphine/naloxone film strip administered sublingually

Buprenorphine/naloxone film strip administered buccally

Outcomes

Primary Outcome Measures

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

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00640835

First Posted

March 14, 2008

Last Updated

November 6, 2012

Sponsor

Indivior Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00640835

Brief Title

Safety and Tolerability of Buprenorphine/Naloxone Film Strips

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2008

Overall Recruitment Status

Completed

Study Start Date

February 2008 (undefined)

Primary Completion Date

October 2008 (Actual)

Study Completion Date

October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Indivior Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Opioid-Related Disorders

Keywords

Opioid dependence

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

382 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sublingual administration

Arm Type

Experimental

Arm Description

Buprenorphine/naloxone film strip administered sublingually

Arm Title

Buccal administration

Arm Type

Experimental

Arm Description

Buprenorphine/naloxone film strip administered buccally

Intervention Type

Drug

Intervention Name(s)

Buprenorphine/naloxone Film Strip

Intervention Description

Buprenorphine/naloxone dosed between 4/1 mg to 32/8 mg once a day for 12 weeks by sublingual route

Intervention Type

Drug

Intervention Name(s)

Buprenorphine/naloxone Film Strip

Intervention Description

Buprenorphine/naloxone dosed between 4/1 mg to 32/8 mg once a day for 12 weeks by buccal route

Primary Outcome Measure Information:

Title

Number of Subjects With Treatment-emergent Adverse Events Associated With the Oral Cavity.

Description

Time Frame

12 weeks

Title

Number of Subjects With Mild, Moderate or Severe Treatment-emergent Adverse Events Associated With the Oral Cavity

Description

Safety and tolerability were evaluated during the 12-week Treatment Phase by oral cavity examination and assessment.

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Donald R. Jasinski, MD

Organizational Affiliation

Johns Hopkins University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Parkway Medical Center

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35215

Country

United States

Facility Name

Winston Technology Research LLC

City

Haleyville

State/Province

Alabama

ZIP/Postal Code

35565

Country

United States

Facility Name

Beeches Family Medicine

City

Jacksonville Beach

State/Province

Florida

ZIP/Postal Code

32250

Country

United States

12. IPD Sharing Statement

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Safety and Tolerability of Buprenorphine/Naloxone Film Strips

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