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

This study has been completed.
Sponsor:
Collaborators:
Reckitt and Colman
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00007527
First received: December 29, 2000
Last updated: January 20, 2009
Last verified: February 2003
  Purpose

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.


Condition Intervention Phase
Opiate Dependence
Drug: naloxone
Drug: buprenorphine
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter Safety Trial of Buprenorphine/Naloxone for the Treatment of Opiate Dependence

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment: 600
Study Start Date: August 1999
Estimated Study Completion Date: January 2002
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.)

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Patients seeking treatment for opiate dependence

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00007527

Locations
United States, New York
Paul Casadonte, M.D. VAMC New York
New York, New York, United States, 10010
United States, Washington
Andrew Saxon, M.D.-Addictions Treatment (116ATC)
Seattle, Washington, United States, 98108
Sponsors and Collaborators
Reckitt and Colman
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00007527     History of Changes
Other Study ID Numbers: 1018
Study First Received: December 29, 2000
Last Updated: January 20, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Department of Veterans Affairs:
buprenorphine and naloxone
opiate dependence
narcotic treatment

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

ClinicalTrials.gov processed this record on July 31, 2014