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Safety and Tolerability of Buprenorphine/Naloxone Film Strips

NCT ID: NCT00640835

Last Updated: 2012-11-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

382 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2008-10-31

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.

Conditions

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Opioid-Related Disorders

Keywords

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Opioid dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sublingual administration

Buprenorphine/naloxone film strip administered sublingually

Group Type EXPERIMENTAL

Buprenorphine/naloxone Film Strip

Intervention Type DRUG

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

Buccal administration

Buprenorphine/naloxone film strip administered buccally

Group Type EXPERIMENTAL

Buprenorphine/naloxone Film Strip

Intervention Type DRUG

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

Interventions

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Buprenorphine/naloxone Film Strip

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

Intervention Type DRUG

Buprenorphine/naloxone Film Strip

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

Intervention Type DRUG

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indivior Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Donald R. Jasinski, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Parkway Medical Center

Birmingham, Alabama, United States

Site Status

Winston Technology Research LLC

Haleyville, Alabama, United States

Site Status

Beeches Family Medicine

Jacksonville Beach, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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RB-US-07-0001

Identifier Type: -

Identifier Source: org_study_id