Utilization of primary care settings for opioid agonist maintenance treatment would facilitate expanding access to and availability of this treatment, but there are no studies that have evaluated the counseling needed in this setting to obtain optimal results. Our current study provides evidence of the efficacy of three times per week (3x/wk) buprenorphine (BUP) maintenance, and 3x/wk BUP dosing will facilitate its use for maintenance treatment in a primary care clinic (PCC). Before widespread implementation in this setting, however, it is essential to evaluate the level of counseling needed for patients with differing prognostic risk factors. The proposed study will compare Standard Medical Management (SMM) vs. SMM enhanced with additional education about addiction and recovery (Enhanced Medical Management, EMM). SMM is a relatively brief intervention that approximates the usual counseling provided by primary care practitioners to patients with chronic medical conditions, such as diabetes. EMM provides a more extended opportunity for a primary care practitioner to educate the patient about the recovery process and provide additional advice about lifestyle changes and 12-step participation. Both SMM and EMM can be easily implemented in a PCC. The study will test the hypothesis that EMM has greater efficacy that SMM for reducing illicit opiodi and other drug use during 3x/wk BUP maintenance in a PCC. Additionally, the study will evaluate potential patient predictors of differential treatment response (cocaine abuse or dependence, cluster B personality disorders, unemployment) and explore whether SMM may be sufficient for some patient groups (e.g. employed patients without comorbid substance use or psychiatric disorders). Opioid-dependent subjects (n=168) will be randomly assigned to SMM or EMM in a 24-wekk trial of 3x/wk BUP maintenance in a hospital PCC. Primary outcome measures assessed during the trial include reductions in illicit opioid use and achievement of documented abstinence from illicit opioids, as assessed by 3x/wk urine toxicology testing and self report. Secondary outcome measures include retention in treatment, reductions in cocaine use and HIV risk, and improved health status. Utilization and costs of services, spillover effects in the PCC, and patient and staff perceptions of benefits and problems with PCC agonist maintenance treatment will also be evaluated.

Agency
National Institute of Health (NIH)
Institute
National Institute on Drug Abuse (NIDA)
Type
Research Project (R01)
Project #
5R01DA009803-08
Application #
6607450
Study Section
Human Development Research Subcommittee (NIDA)
Program Officer
Czechowicz, Dorynne D
Project Start
1995-08-01
Project End
2005-06-30
Budget Start
2003-07-01
Budget End
2005-06-30
Support Year
8
Fiscal Year
2003
Total Cost
$445,773
Indirect Cost
Name
Yale University
Department
Psychiatry
Type
Schools of Medicine
DUNS #
043207562
City
New Haven
State
CT
Country
United States
Zip Code
06520
Edelman, E Jennifer; Dinh, An T; Moore, Brent A et al. (2012) Human immunodeficiency virus testing practices among buprenorphine-prescribing physicians. J Addict Med 6:159-65
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Sullivan, Lynn E; Botsko, Michael; Cunningham, Chinazo O et al. (2011) The impact of cocaine use on outcomes in HIV-infected patients receiving buprenorphine/naloxone. J Acquir Immune Defic Syndr 56 Suppl 1:S54-61
Sullivan, Lynn E; Moore, Brent A; O'Connor, Patrick G et al. (2010) The association between cocaine use and treatment outcomes in patients receiving office-based buprenorphine/naloxone for the treatment of opioid dependence. Am J Addict 19:53-8
Barry, Declan T; Irwin, Kevin S; Jones, Emlyn S et al. (2010) Opioids, chronic pain, and addiction in primary care. J Pain 11:1442-50
Wang, Emily A; Moore, Brent A; Sullivan, Lynn E et al. (2010) Effect of incarceration history on outcomes of primary care office-based buprenorphine/naloxone. J Gen Intern Med 25:670-4
Jones, Emlyn S; Moore, Brent A; Sindelar, Jody L et al. (2009) Cost analysis of clinic and office-based treatment of opioid dependence: results with methadone and buprenorphine in clinically stable patients. Drug Alcohol Depend 99:132-40
Barry, Declan T; Irwin, Kevin S; Jones, Emlyn S et al. (2009) Integrating buprenorphine treatment into office-based practice: a qualitative study. J Gen Intern Med 24:218-25
Sullivan, Lynn E; Moore, Brent A; Chawarski, Marek C et al. (2008) Buprenorphine/naloxone treatment in primary care is associated with decreased human immunodeficiency virus risk behaviors. J Subst Abuse Treat 35:87-92
Fiellin, David A; Moore, Brent A; Sullivan, Lynn E et al. (2008) Long-term treatment with buprenorphine/naloxone in primary care: results at 2-5 years. Am J Addict 17:116-20

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