Safety and Tolerability of Buprenorphine/Naloxone Film Strips

NCT00640835 | Completed Phase 2 Results

• 1 other identifier: RB-US-07-0001
• Study Type: interventional
• Target: 382
• Locations: 1 country
• Sites: 3

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.

Conditions

Opioid-Related Disorders

Keywords

Opioid dependence

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Sublingual administration

EXPERIMENTAL

Buprenorphine/naloxone film strip administered sublingually

Drug: Buprenorphine/naloxone Film Strip

Buccal administration

EXPERIMENTAL

Buprenorphine/naloxone film strip administered buccally

Drug: Buprenorphine/naloxone Film Strip

Interventions

Buprenorphine/naloxone Film Strip DRUG

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

Sublingual administration

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indivior Inc.: lead

Study Sites (3)

Parkway Medical Center

Birmingham, Alabama, 35215, United States

Location

Winston Technology Research LLC

Haleyville, Alabama, 35565, United States

Location

Beeches Family Medicine

Jacksonville Beach, Florida, 32250, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Buprenorphine

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Results Point of Contact

• Title: Rolley E. Johnson, PharmD, Vice President, Clinical, Scientific and Regulatory Affairs
• Organization: Reckitt Benckiser Pharmaceuticals, Inc.

ed.johnson@reckittbenckiser.com

804-379-1090

Study Officials

• Donald R. Jasinski, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2008
• First Posted: March 21, 2008
• Study Start: February 1, 2008
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: November 12, 2012
• Results First Posted: October 26, 2010

Record last verified: 2008-10

Locations

US (3)