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| Descriptive Information Fields | |||||
| Brief Title † | Buprenorphine Maintenance vs. Detoxification in Prescription Opioid Dependence | ||||
| Official Title † | Buprenorphine Maintenance vs. Detoxification in Prescription Opioid Dependence | ||||
| Brief Summary | The aim of the study is to determine whether buprenorphine/naloxone maintenance versus detoxification using buprenorphine/naloxone, in prescription opioid dependent patients receiving primary care management and drug counseling in an office-based setting, leads to decreased illicit opioid use. |
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| Detailed Description | Prescription opioid dependence is increasing and creates a significant public health burden, but office-based physicians lack evidence-based guidelines to decide between maintenance or detoxification treatment with buprenorphine/naloxone. The proposed study compares buprenorphine/naloxone maintenance (Mtn) vs. detoxification (Dtx) in a 18-week randomized clinical trail in a heterogeneous population of prescription opioid dependent patients (N=120) in a primary care clinic. Patients are randomized to Mtn or Dtx after a 2-week induction period. Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, buprenorphine/naloxone will continue unchanged for the remainder of the study. In Dtx, the dosage of buprenorphine/naloxone will be tapered to zero over the next 3 weeks, and patients will not receive additional buprenorphine/naloxone for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup. The study will test the hypothesis that Mtn will lead to decreased illicit drug use and will demonstrate incremental cost-effectiveness compared to Dtx. Relevance to public health: The results of this study will help define the role of maintenance vs. detoxification with buprenorphine/naloxone in the care of prescription opioid dependent patients in primary care. |
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| Study Phase | Phase IV | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||
| Primary Outcome Measure † | Illicit opioid use [ Time Frame: 18 weeks ] [ Designated as safety issue: No ] | ||||
| Secondary Outcome Measure † | Proportion of patients protectively transferred [ Time Frame: 18 weeks ] [ Designated as safety issue: No ] Retention in treatment [ Time Frame: 18 weeks ] [ Designated as safety issue: No ] Reduction in cocaine use [ Time Frame: 18 weeks ] [ Designated as safety issue: No ] Reductions in HIV risk [ Time Frame: 18 weeks ] [ Designated as safety issue: No ] Patient satisfaction [ Time Frame: 18 weeks ] [ Designated as safety issue: No ] Health status [ Time Frame: 18 weeks ] [ Designated as safety issue: No ] Utilization and costs of services [ Time Frame: 18 weeks ] [ Designated as safety issue: No ] |
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| Condition † | Opiate Dependence | ||||
| Intervention † | Behavioral: Behavioral: Buprenorphine/naloxone maintenance (Mtn) Behavioral: Behavioral: Buprenorphine/naloxone detoxification (Dtx) |
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| MEDLINE PMIDs | |||||
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| Recruitment Information Fields | |||||
| Recruitment Status † | Not yet recruiting | ||||
| Enrollment † | 120 | ||||
| Start Date † | July 2008 | ||||
| Completion Date | April 2012 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† |
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| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00555425 | ||||
| Organization ID | 1R01DA020576-01A1 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | National Institute on Drug Abuse (NIDA) | ||||
| Collaborators †† | Yale University | ||||
| Investigators † |
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| Information Provided By | National Institute on Drug Abuse (NIDA) | ||||
| Verification Date | June 2008 | ||||
| First Received Date † | November 6, 2007 | ||||
| Last Updated Date | June 11, 2008 | ||||
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