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| Descriptive Information Fields | |||||
| Brief Title † | Counseling Conditions for Buprenorphine in a Primary Care Clinic - 1 | ||||
| Official Title † | Counseling Conditions for Thrice Weekly Buprenorphine in a Primary Care Clinic | ||||
| Brief Summary | The purpose of this study is to compare the Standard Medical Management (SMM) vs. SMM enhanced with additional education about addiction and recovery (Enhanced Medical Management, EMM) |
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| Detailed Description | A randomized trial, in a hospital primary care clinic, for 24 weeks, of 168 opioid-dependent subjects, maintained on buprenorphine 3x/week, and counseled with Standard or Enhanced Medical Management. SMM is a brief intervention similar to that provided by primary practitioners to patients with chronic medical conditions such as diabetes. EMM is an intervention that provides education about the recovery process and advice about lifestyle changes and 12-step participation. Outcome measures include reduction in opioid use and abstinence from opioids, documented by 3x/week urine testing and self report. |
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| Study Phase | Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized | ||||
| Primary Outcome Measure † | |||||
| Secondary Outcome Measure † | |||||
| Condition † | Heroin Dependence Opioid-Related Disorders Substance Abuse, Intravenous |
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| Intervention † | Drug: Buprenorphine | ||||
| MEDLINE PMIDs | |||||
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| Recruitment Information Fields | |||||
| Recruitment Status † | Not yet recruiting | ||||
| Enrollment † | 0 | ||||
| Start Date † | |||||
| Completion Date | |||||
| Eligibility Criteria † | Inclusion criteria: Subjects meeting FDA criteria for opioid agonist maintenance treatment and DSM-IV criteria for opioid dependence will be eligible for the study. Women of childbearing age will be included provided they agree to adequate contraception and to monthly pregnancy monitoring throughout the study. Exclusion criteria include: pregnancy, current dependence on alcohol, benzodiazepines or sedatives; current suicide or homicide risk; current psychotic disorder or major depression; inability to read or understand English; life-threatening or unstable medical problems. |
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| Gender | Both | ||||
| Ages | 21 Years to 55 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts †† |
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| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00023283 | ||||
| Organization ID | NIDA-9803-1 | ||||
| Secondary IDs †† | R01-9803-1 | ||||
| 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 | December 2002 | ||||
| First Received Date † | August 30, 2001 | ||||
| Last Updated Date | November 3, 2005 | ||||
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