Background
Opioid dependence is common in HIV clinics. Buprenorphine/naloxone (BUP) is an effective treatment for 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.
Setting
HIV clinic in Baltimore, Maryland.
Patients
93 HIV-infected, opioid-dependent subjects who were not receiving opioid agonist therapy and were not dependent on alcohol or benzodiazepines.
Intervention
The clinic-based BUP strategy included BUP induction and dose titration, urine drug test monitoring, and individual counseling; the referred-treatment arm 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 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%–84%) in clinic-based BUP and 41% (29%–53%) in referred-treatment (p<0.001). Opioid and cocaine positive urine drug tests were significantly less frequent in clinic-based BUP than in referred-treatment, and study subjects in clinic-based BUP attended significantly more HIV primary care visits than study subjects in referred-treatment. Use of antiretroviral therapy and changes in HIV RNA levels and CD4 cell counts did not differ in the 2 arms of the study.
Limitations
This was a small single-center study, follow-up was only fair, and there was an imbalance in recent drug injection in the study arms at baseline.
Conclusions
This study suggests that management of HIV-infected, opioid-dependent patients with a clinic-based BUP strategy facilitates access to opioid agonist therapy and improves substance abuse treatment outcomes.
Primary Funding Source
Health Resources Services Administration, Special Projects of National Significance.
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Background
Opioid dependence and HIV infection are associated with poor health-related quality of life (HRQOL). Buprenorphine/naloxone (bup/nx) provided in HIV care settings may improve HRQOL.
Methods
We surveyed 289 HIV-infected opioid-dependent persons treated with clinic-based bup/nx about HRQOL using the Short Form Health Survey (SF-12) administered at baseline, 3, 6, 9, and 12 months. We used normalized SF-12 scores which correspond to a mean HRQOL of 50 for the general U.S. population (SD 10, possible range 0–100). We compared mean normalized mental and physical composite and component scores in quarters 1, 2, 3, and 4 with baseline scores using GEE models. We assessed the effect of clinic-based bup/nx prescription on HRQOL composite scores using mixed effects regression with site as random effect and time as repeated effect.
Results
Baseline normalized SF-12 scores were lower than the general U.S. population for all HRQOL domains. Average composite mental HRQOL improved from 38.3 (SE 12.5) to 43.4 (SE 13.2) (β 1.13 [95% CI 0.72, 1.54]) and composite physical HRQOL remained unchanged (β 0.21 [95% CI −0.16, 0.57]) over 12 months follow-up. Continued bup/nx treatment across all four quarters was associated with improvements in both physical (β 2.38 [95% CI 0.63, 4.12]) and mental (β 2.51 [95% CI 0.42, 4.60]) HRQOL after adjusting for other contributors to HRQOL.
Conclusions
Clinic-based bup/nx maintenance therapy is potentially effective in ameliorating some of the adverse effects of opioid dependence on HRQOL for HIV-infected populations.
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