Safety and Tolerability of Buprenorphine/Naloxone Film Strips - Full Text View

Purpose

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	Intervention	Phase
Opioid-Related Disorders	Drug: Buprenorphine/naloxone Film Strip	Phase II

ChemIDplus related topics:

Naloxone Naloxone hydrochloride Buprenorphine Buprenorphine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety Study

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

Further study details as provided by Reckitt Benckiser Pharmaceuticals, Inc:

Primary Outcome Measures:

Severity and frequency of oral mucosal adverse events [ Time Frame: During active treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Adverse events [ Time Frame: During active treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	300
Study Start Date:	March 2008
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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
2: Experimental 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

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

United States, Maryland
	Johns Hopkins Bayview Medical Center
	Baltimore, Maryland, United States, 21224

Sponsors and Collaborators

Reckitt Benckiser Pharmaceuticals, Inc

Investigators


Principal Investigator:	Donald R. Jasinski, MD	Johns Hopkins University

More Information

Responsible Party:	Reckitt Benckiser Pharmaceuticals Inc ( Rolley E. Johnson, Pharm.D./Vice-President, Clinical, Scientific & Regulatory Affairs )
Study ID Numbers:	RB-US-07-0001
First Received:	March 14, 2008
Last Updated:	April 21, 2008
ClinicalTrials.gov Identifier:	NCT00640835
Health Authority:	United States: Food and Drug Administration

Keywords provided by Reckitt Benckiser Pharmaceuticals, Inc:

Opioid dependence

Study placed in the following topic categories:

Buprenorphine

Mental Disorders

Substance-Related Disorders

Disorders of Environmental Origin

Opioid-Related Disorders

Naloxone

Additional relevant MeSH terms:

Sensory System Agents

Therapeutic Uses

Narcotic Antagonists

Physiological Effects of Drugs

Central Nervous System Depressants

Narcotics

Peripheral Nervous System Agents

Analgesics

Central Nervous System Agents

Pharmacologic Actions

Analgesics, Opioid

ClinicalTrials.gov processed this record on October 17, 2008

Sponsored by:	Reckitt Benckiser Pharmaceuticals, Inc
Information provided by:	Reckitt Benckiser Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:	NCT00640835