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Determine the Safety of a Sublingual Tablet Formulation of Buprenorphine and Naloxone by Extending the Combination Tablet Availability to Physicians in Office-Based Practice

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00007527
Recruitment Status : Completed
First Posted : January 1, 2001
Last Update Posted : January 21, 2009
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
Reckitt and Colman
Information provided by:
VA Office of Research and Development

Tracking Information
First Submitted Date  ICMJE December 29, 2000
First Posted Date  ICMJE January 1, 2001
Last Update Posted Date January 21, 2009
Study Start Date  ICMJE August 1999
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00007527 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Determine the Safety of a Sublingual Tablet Formulation of Buprenorphine and Naloxone by Extending the Combination Tablet Availability to Physicians in Office-Based Practice
Official Title  ICMJE A Multicenter Safety Trial of Buprenorphine/Naloxone for the Treatment of Opiate Dependence
Brief Summary

The CS 1018 study will recruit a total of 600 patients seeking treatment for opiate dependence. They will be recruited from six states (Florida, New York, Texas, California, Washington, and Illinois), with up to ten private physician sites or clinics participating in each state. Coordination of the participating sites and clinics in each of the six states will be performed from an associated Department of Veterans Affairs Medical Center (Tampa VAMC, New York City VAMC, San Antonio VAMC, Long Beach VAMC, Seattle VAMC, and Hines VAMC). The Principal Investigator (PI) at each of the six VAMC?s will be a physician experienced in the treatment of opiate dependent patients.

Patients will be recruited by any of numerous strategies including word of mouth, self-referral, local fliers, newspapers, and radio advertisements. This study will be conducted open label with no random assignment or stratification. Patients may be accepted for detoxification or longer-term treatment (6 to 12 months of buprenorphine/naloxone therapy). Patients under the age of 21 will initially be admitted for detoxification; longer treatment of these patients will be based on physician judgement of the necessary of continued treatment. Patients will be inducted directly into buprenorphine/naloxone 4:1 combination tablets. Patients treated in private practice will be asked to sign a treatment contract which will delineate the terms and conditions of treatment.

Detailed Description

Primary Hypothesis: The purpose of this study is to determine the safety of a sublingual tablet formulation of buprenorphine and naloxone by extending the combination tablet availability to physicians in office-based practice. The general consensus is that the initial effort should involve physicians experienced in the treatment of opiate dependence. The fact that buprenorphine is already in a formulation available as a schedule V analgesic should allow for its administration in and dispensing from a physician's office. The research data showing its high level of safety, patient acceptance and clinical efficacy, and its availability as a formulation that can be given for take-home dosing with low intravenous abuse liability, argue compellingly for exploring alternative implementation strategies in settings other than traditional narcotic treatment programs.

Secondary Hypothesis: None

Intervention: This is a single treatment study of a sublingual 4:1 buprenorphine/naloxone combination tablet. Dosing can range from 2 mg at baseline (expressed as amount of buprenorphine) to 24 mg (maximum dose used in study).

Primary Outcomes: Patient retention rate, percentage of urine samples negative for opiates

Study Abstract: The CS 1018 study recruited a total of 582 patients seeking treatment for opiate dependence. They were recruited from six states (Florida, New York, Texas, California, Washington, and Illinois), with up to ten private physician sites or clinics participating in each state. Coordination of the participating sites and clinics in each of the six states was performed from an associated Department of Veterans Affairs Medical Center (Tampa VAMC, New York City VAMC, San Antonio VAMC, Long Beach VAMC, Seattle VAMC, and Hines VAMC). The Principal Investigator (PI) at each of the six VAMC's was a physician experienced in the treatment of opiate dependent patients. In addition, a study coordinator was hired at each of the six VAMC's to coordinate both the collection and completion of study forms. Editing and correction of all data study case report forms was coordinated and handled by one of the state specific study coordinators. Patients were recruited by any of numerous strategies including utilization of central recruiting telephone number systems, word of mouth, self-referral, local fliers, newspapers, and radio advertisements. This study was conducted open label with no random assignment or stratification. Patients were accepted for detoxification or longer-term treatment (6 to 12 months of buprenorphine/naloxone therapy). Patients under the age of 21 were initially admitted for detoxification; longer treatment of these patients was based on physician judgement of the necessary of continued treatment. Patients were inducted directly into buprenorphine/naloxone 4:1 combination tablets. Patients treated in private practice were asked to sign a treatment contract which delineated the terms and conditions of treatment.

Results:

Main Manuscript - (record authors, title, journal, year, volume, page nos.)

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Opiate Dependence
Intervention  ICMJE
  • Drug: naloxone
  • Drug: buprenorphine
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June¬†23,¬†2005)
600
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE January 2002
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE Patients seeking treatment for opiate dependence
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00007527
Other Study ID Numbers  ICMJE 1018
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE US Department of Veterans Affairs
Collaborators  ICMJE
  • National Institute on Drug Abuse (NIDA)
  • Reckitt and Colman
Investigators  ICMJE Not Provided
PRS Account VA Office of Research and Development
Verification Date February 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP