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Clinic-Based Treatment of Opioid-Dependent HIV-Infected Patients Versus Referral to an Opioid Treatment Program: A Randomized Trial

Gregory M. Lucas, MD, PhD; Amina Chaudhry, MD, MPH; Jeffrey Hsu, MD; Tanita Woodson, CRNP; Bryan Lau, PhD; Yngvild Olsen, MD; Jeanne C. Keruly, CRNP; David A. Fiellin, MD; Ruth Finkelstein, ScD; Patricia Barditch-Crovo, MD; Katie Cook, BA; and Richard D. Moore, MD
[+] Article and Author Information

From Johns Hopkins University School of Medicine, Johns Hopkins Bloomberg School of Public Health, and Baltimore Substance Abuse Systems, Baltimore, Maryland; Yale University School of Medicine, New Haven, Connecticut; and New York Academy of Medicine, New York, New York.


Disclaimer: The views expressed in this article reflect those of the authors and not those of the Substance Abuse and Mental Health Services Administration, the National Center for Research Resources, the National Institutes of Health, the U.S. Department of Health and Human Services, or the U.S. government.

Grant Support: By the Health Resources and Services Administration Special Projects of National Significance program (H97HA03794) and the National Center for Research Resources (UL1 RR 025005), a component of the National Institutes of Health and NIH Roadmap for Medical Research. Drs. Lucas, Lau, Fiellin, and Moore were also supported by the National Institutes of Health (K23DA015616, R01DA018577, K01AI071754, R01DA019511, R01DA025991, R01DA020576, K24DA000432, R01DA011602, and R01AA016893). Reckitt Benckiser Pharmaceuticals provided buprenorphinenaloxone for uninsured study participants.

Potential Conflicts of Interest: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M09-2112.

Reproducible Research Statement:Study protocol and statistical code: Available from Dr. Lucas (e-mail, glucas@jhmi.edu). Data set: Not available.

Requests for Single Reprints: Gregory M. Lucas, MD, PhD, 1830 East Monument Street, Room 435A, Baltimore, MD 21287; e-mail, glucas@jhmi.edu.

Current Author Addresses: Dr. Lucas: 1830 East Monument Street, Room 435A, Baltimore, MD 21287.

Dr. Chaudhry: Center for Substance Abuse Treatment, Substance Abuse and Mental Health Services Administration, 1 Choke Cherry Road, Room 2-1079, Rockville, MD 20857.

Dr. Hsu: 600 North Wolfe Street, Osler 320, Baltimore, MD 21287.

Ms. Woodson: 2024 East Monument Street, Room 2-505, Baltimore, MD 21287.

Dr. Lau: 615 North Wolfe Street, E7150, Baltimore, MD 21205.

Dr. Olsen: Baltimore Substance Abuse Systems, One North Charles Street, Suite 1600, Baltimore MD 21201-3718.

Ms. Keruly: 1830 East Monument Street, Room 8014, Baltimore, MD 21287.

Dr. Fiellin: 367 Cedar Street, P.O. Box 208093, New Haven, CT 06520-8093.

Dr. Finkelstein: The New York Academy of Medicine, 1216 Fifth Avenue, New York, NY 10029-5202.

Dr. Barditch-Crovo: 1830 East Monument Street, Room 463B, Baltimore, MD 21287.

Ms. Cook: 1830 East Monument Street, Room 458, Baltimore, MD 21287.

Dr. Moore: 1830 East Monument Street, Room 8059, Baltimore, MD 21287.

Author Contributions: Conception and design: G.M. Lucas, J. Hsu, Y. Olsen, D.A. Fiellin, R. Finkelstein, R.D. Moore.

Analysis and interpretation of the data: G.M. Lucas, B. Lau, D.A. Fiellin, R.D. Moore.

Drafting of the article: G.M. Lucas, B. Lau, J.C. Keruly.

Critical revision of the article for important intellectual content: G.M. Lucas, A. Chaudhry, B. Lau, Y. Olsen, D.A. Fiellin, R.D. Moore.

Final approval of the article: G.M. Lucas, A. Chaudhry, B. Lau, D.A. Fiellin, R.D. Moore.

Provision of study materials or patients: G.M. Lucas, A. Chaudhry, J. Hsu, T. Woodson.

Statistical expertise: B. Lau.

Obtaining of funding: G.M. Lucas, R. Finkelstein.

Administrative, technical, or logistic support: G.M. Lucas, A. Chaudhry, T. Woodson, Y. Olsen, J.C. Keruly, D.A. Fiellin, P. Barditch-Crovo, K. Cook.

Collection and assembly of data: G.M. Lucas, A. Chaudhry, T. Woodson, J.C. Keruly, K. Cook.


Ann Intern Med. 2010;152(11):704-711. doi:10.7326/0003-4819-152-11-201006010-00003
Text Size: A A A

Background: Opioid dependence is common in HIV clinics. Buprenorphine–naloxone (BUP) is an effective treatment of opioid dependence that may be used in routine medical settings.

Objective: To compare clinic-based treatment with BUP (clinic-based BUP) with case management and referral to an opioid treatment program (referred treatment).

Design: Single-center, 12-month randomized trial. Participants and investigators were aware of treatment assignments. (ClinicalTrials.gov registration number: NCT00130819)

Setting: HIV clinic in Baltimore, Maryland.

Patients: 93 HIV-infected, opioid-dependent participants who were not receiving opioid agonist therapy and were not dependent on alcohol or benzodiazepines.

Intervention: Clinic-based BUP included BUP induction and dose titration, urine drug testing, and individual counseling. Referred treatment included case management and referral to an opioid-treatment program.

Measurements: Initiation and long-term receipt of opioid agonist therapy, urine drug test results, visit attendance with primary HIV care providers, use of antiretroviral therapy, and changes in HIV RNA levels and CD4 cell counts.

Results: The average estimated participation in opioid agonist therapy was 74% (95% CI, 61% to 84%) for clinic-based BUP and 41% (CI, 29% to 53%) for referred treatment (P < 0.001). Positive test results for opioids and cocaine were significantly less frequent in clinic-based BUP than in referred treatment, and study participants receiving clinic-based BUP attended significantly more HIV primary care visits than those receiving referred treatment. Use of antiretroviral therapy and changes in HIV RNA levels and CD4 cell counts did not differ between the 2 groups.

Limitation: This was a small single-center study, follow-up was only moderate, and the study groups were unbalanced in terms of recent drug injections at baseline.

Conclusion: Management of HIV-infected, opioid-dependent patients with a clinic-based BUP strategy facilitates access to opioid agonist therapy and improves outcomes of substance abuse treatment.

Primary Funding Source: Health Resources and Services Administration Special Projects of National Significance program.

Figures

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Figure 1.
Study flow diagram.

BUP=buprenorphinenaloxone.

*Censored persons had not completed follow-up when the study concluded.

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Figure 2.
Probability of receiving opioid agonist therapy at study follow-up visits.

Observed estimates are shown for clinic-based buprenorphinenaloxone (BUP) (circles) and referred treatment (triangles); vertical lines represent 95% CIs. Mixed-effects model-based estimates for receiving opioid agonist therapy are shown for clinic-based BUP (squares) and referred treatment (diamonds); shading represents 95% confidence bands. The average model-based estimates for receiving opioid agonist therapy were significantly higher for clinic-based BUP than for referred treatment (P< 0.001).

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Figure 3.
Probability of positive results for opioid and cocaine use on urine drug tests at study visits.

Observed estimates are shown for clinic-based buprenorphinenaloxone (BUP) (circles) and referred treatment (triangles); vertical lines represent 95% CIs. Mixed-effects model-based estimates for positive urine drug test results are shown for clinic-based BUP (squares) and referred treatment (diamonds); shading represents 95% confidence bands. The average model-based estimates for opioid-positive results and cocaine-positive results were significantly lower for clinic-based BUP than for referred treatment (P= 0.015 and 0.012, respectively).

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Appendix Figure.
Probability of receiving opioid agonist therapy at study follow-up visits.

Observed estimates are shown for clinic-based buprenorphinenaloxone (BUP) (solid circles) and referred treatment (diamonds); vertical lines represent 95% CIs. We used pattern-mixture models to assess the influence of missing data on estimated study group differences in participation in opioid agonist therapy. Inclusion of pattern-mixture variables improved the fit of the model (P= 0.023, likelihood ratio test). Estimates are shown for participants who missed no study visits in clinic-based BUP (squares) and referred treatment (open circles); green shading represents 95% confidence bands. Estimates are also shown for participants who missed 1 or more follow-up visit in clinic-based BUP (triangles) and in referred treatment (asterisks); diagonal shading represents 95% confidence bands. In the pattern-mixture model, the estimated average participation in opioid agonist therapy was significantly higher for clinic-based BUP than for referred treatment (P< 0.001).

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