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Safety and Tolerability of Buprenorphine/Naloxone Film Strips

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ClinicalTrials.gov Identifier: NCT00640835
Recruitment Status : Completed
First Posted : March 21, 2008
Results First Posted : October 26, 2010
Last Update Posted : November 12, 2012
Sponsor:
Information provided by (Responsible Party):
Indivior Inc.

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.

Condition or disease Intervention/treatment Phase
Opioid-Related Disorders Drug: Buprenorphine/naloxone Film Strip Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 382 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : February 2008
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Sublingual administration
Buprenorphine/naloxone film strip administered sublingually
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
Experimental: Buccal administration
Buprenorphine/naloxone film strip administered buccally
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



Primary Outcome Measures :
  1. Number of Subjects With Treatment-emergent Adverse Events Associated With the Oral Cavity. [ Time Frame: 12 weeks ]

    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


  2. Number of Subjects With Mild, Moderate or Severe Treatment-emergent Adverse Events Associated With the Oral Cavity [ Time Frame: 12 weeks ]
    Safety and tolerability were evaluated during the 12-week Treatment Phase by oral cavity examination and assessment.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00640835


Locations
United States, Alabama
Parkway Medical Center
Birmingham, Alabama, United States, 35215
Winston Technology Research LLC
Haleyville, Alabama, United States, 35565
United States, Florida
Beeches Family Medicine
Jacksonville Beach, Florida, United States, 32250
Sponsors and Collaborators
Indivior Inc.
Investigators
Principal Investigator: Donald R. Jasinski, MD Johns Hopkins University

Responsible Party: Indivior Inc.
ClinicalTrials.gov Identifier: NCT00640835     History of Changes
Other Study ID Numbers: RB-US-07-0001
First Posted: March 21, 2008    Key Record Dates
Results First Posted: October 26, 2010
Last Update Posted: November 12, 2012
Last Verified: October 2008

Keywords provided by Indivior Inc.:
Opioid dependence

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Buprenorphine
Buprenorphine, Naloxone Drug Combination
Naloxone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists