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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 Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Determine the safety of a sublingual tablet formulation of buprenorphine and naloxone by extending the combination tablet availability to physicians in office-based practice conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Determine the safety of a sublingual tablet formulation of buprenorphine and naloxone by extending the combination tablet availability to physicians in office-based practice Clinical research trials and Determine the safety of a sublingual tablet formulation of buprenorphine and naloxone by extending the combination tablet availability to physicians in office-based practice medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Determine the safety of a sublingual tablet formulation of buprenorphine and naloxone by extending the combination tablet availability to physicians in office-based practice. Determine the safety of a sublingual tablet formulation of buprenorphine and naloxone by extending the combination tablet availability to physicians in office-based practice Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Determine the safety of a sublingual tablet formulation of buprenorphine and naloxone by extending the combination tablet availability to physicians in office-based practice clinical trial. Participants frequently get the best healthcare available for their Determine the safety of a sublingual tablet formulation of buprenorphine and naloxone by extending the combination tablet availability to physicians in office-based practice condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "D" Clinical Trials Conditions > Determine the safety of a sublingual tablet formulation of buprenorphine and naloxone by extending the combination tablet availability to physicians in office-based practice  Determine the safety of a sublingual tablet formulation of buprenorphine and naloxone by extending the combination tablet availability to physicians in office-based practice
Determine the safety of a sublingual tablet formulation of buprenorphine and naloxone by extending the combination tablet availability to physicians in office-based practice
For Condition: Opiate Dependence
Status: Completed
Sponsor(s): Department of Veterans Affairs , Department of Veterans Affairs Cooperative Studies Program,National Institute on Drug Abuse (NIDA),Reckitt and Colman
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Minimum Age/Maximum Age: 15 Years/
Genders: Both
Protocol Entry Criteria: Patients seeking treatment for opiate dependence
Total Enrollment: 600
Location and Contact Information:
Paul Casadonte, M.D. VAMC New York
New York City, New York, 10010
United States
Andrew Saxon, M.D.-Addictions Treatment (116ATC)
Seattle, Washington, 98108
United States
Additional Information:
Study ID Numbers: 1018;
Study Start Date: August 1999
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00007527
Other Opiate Dependence Studies:
1. The Maternal Lifestyle Study (MLS)
2. Determine the safety of a sublingual tablet formulation of buprenorphine and naloxone by extending the combination tablet availability to physicians in office-based practice
Related Studies:
Other Opiate Dependence Clinical Trials
Other Washington Clinical Trials
Other Seattle Clinical Trials
Determine the safety of a sublingual tablet formulation of buprenorphine and naloxone by extending the combination tablet availability to physicians in office-based practice
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