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| Sponsors and Collaborators: |
National Institute on Drug Abuse (NIDA) Yale University |
| Information provided by: | National Institute on Drug Abuse (NIDA) |
| ClinicalTrials.gov Identifier: | NCT00023283 |
Purpose
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)
| Condition | Intervention | Phase |
|
Heroin Dependence Opioid-Related Disorders Substance Abuse, Intravenous |
Drug: Buprenorphine |
Phase II |
| MedlinePlus related topics: | Heroin |
| Drug Information available for: | Buprenorphine Buprenorphine hydrochloride |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized |
| Official Title: | Counseling Conditions for Thrice Weekly Buprenorphine in a Primary Care Clinic |
| Estimated Enrollment: | 0 |
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.
Eligibility
| Ages Eligible for Study: | 21 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations| Contact: Richard Schottenfeld, M.D. | (203)974-7349 | richard.schottenfeld@yale.edu |
| United States, Connecticut | |||||
| APT Residential Services Division | |||||
| New Haven, Connecticut, United States, 06519 | |||||
| National Institute on Drug Abuse (NIDA) |
| Yale University |
| Principal Investigator: | Richard Schottenfeld, M.D. | Yale University |
More Information
| Study ID Numbers: | NIDA-9803-1, R01-9803-1 |
| First Received: | August 30, 2001 |
| Last Updated: | November 3, 2005 |
| ClinicalTrials.gov Identifier: | NCT00023283 |
| Health Authority: | United States: Federal Government |
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