Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00007527
Status:
COMPLETED
Last Update Posted:
2009-01-21
First Post:
2000-12-29
Brief Title:
Determine the Safety of a Sublingual Tablet Formulation of Buprenorphine and Naloxone by Extending the Combination Tablet Availability to Physicians in Office-Based Practice
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
A Multicenter Safety Trial of BuprenorphineNaloxone for the Treatment of Opiate Dependence
Status:
COMPLETED
Status Verified Date:
2003-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 VAMCs 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 buprenorphinenaloxone 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 buprenorphinenaloxone 41 combination tablets Patients treated in private practice will be asked to sign a treatment contract which will delineate the terms and conditions of treatment
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 buprenorphinenaloxone 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 buprenorphinenaloxone 41 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 physicians 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 41 buprenorphinenaloxone 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 VAMCs was a physician experienced in the treatment of opiate dependent patients In addition a study coordinator was hired at each of the six VAMCs 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 buprenorphinenaloxone 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 buprenorphinenaloxone 41 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
Secondary Hypothesis None
Intervention This is a single treatment study of a sublingual 41 buprenorphinenaloxone 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 VAMCs was a physician experienced in the treatment of opiate dependent patients In addition a study coordinator was hired at each of the six VAMCs 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 buprenorphinenaloxone 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 buprenorphinenaloxone 41 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None