Clinic-based treatment of opioid-dependent HIV-infected patients versus referral to an opioid treatment program: A randomized trial

Abstract

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.

Figure 1

Disposition of HIV-infected, opioid-dependent participants enrolled in a randomized trial comparing clinic-based BUP to referred-treatment. Follow-up shows the number (%) of subjects attending follow-up study visits. Censored individuals had not completed follow-up when the study concluded.

Figure 2

Probability of receiving opioid agonist therapy at study follow-up visits. Observed estimates are shown for clinic-based BUP (open triangles) and referred-treatment (open circles) with vertical lines representing 95% confidence intervals. Mixed-effects model-based estimates for receiving opioid agonist therapy are shown for clinic-based BUP (solid triangles) and referred-treatment (solid circles) with 95% confidence bands shown as shading. The average model-based estimates for receiving opioid agonist therapy were significantly higher for clinic-based BUP than referred-treatment (p<0.001)

Figure 3

Probability of positive opioid (a) and cocaine (b) urine drug tests at study visits. Observed estimates are shown for clinic-based BUP (open triangles) and referred-treatment (open circles) with vertical lines representing 95% confidence intervals. Mixed-effects model-based estimates for positive urine drug tests are shown for clinic-based BUP (solid triangles) and referred-treatment (solid circles) with 95% confidence bands shown as shading. The average model-based estimates for opioid positive and cocaine positive urine drug test were significantly lower in clinic-based BUP than in referred-treatment (p=0.015 and p=0.012, respectively).