title: A trial of integrated buprenorphine/naloxone and HIV clinical care.
abstract: BACKGROUND
  Untreated opioid dependence adversely affects the care of human immunodeficiency virus (HIV)-positive patients. Buprenorphine, a partial opioid agonist, is available for maintenance treatment of opioid dependence in HIV specialty settings. We investigated the feasibility and efficacy of integrating buprenorphine, along with 2 levels of counseling, into HIV clinical care.
  
  
  METHODS
  HIV-positive, opioid-dependent patients were enrolled in a 12-week pilot study and randomized to receive daily buprenorphine/naloxone treatment along with either brief physician management or physician management combined with nurse-administered drug counseling and adherence management. Primary outcomes included treatment retention; illicit drug use, assessed by urine toxicology test and self-report; CD4 lymphocyte counts; and log(10) HIV type 1 (HIV-1) RNA levels.
  
  
  RESULTS
  Of the 16 patients who received at least 1 dose of buprenorphine, 13 (81%) completed 12 weeks of treatment. The proportion of opioid-positive weekly urine test results decreased from 100% at baseline to 32% (month 1), 20% (month 2), and 16% (month 3). Only 4 patients reported any opioid use (in the prior 7 days) during the 12-week study. CD4 lymphocyte counts remained stable over the course of the study. The mean log(10) HIV-1 RNA level (+/- standard deviation) declined significantly, from 3.66+/-1.06 log(10) HIV-1 RNA copies/mL at baseline to 3.0+/-0.57 log(10) HIV-1 RNA copies/mL at month 3 (P<.05). No significant differences based on counseling intervention were detected. All 13 patients who completed the study continued to receive treatment in an extension phase of at least 0-15 months' duration.
  
  
  CONCLUSIONS
  We conclude that it is feasible to integrate buprenorphine into HIV clinical care for the treatment of opioid dependence. Patients experienced good treatment retention and reductions in their opioid use. HIV biological markers remained stable or improved during buprenorphine/naloxone treatment.
authors.affiliation: Department of Internal Medicine, Yale University School of Medicine, New Haven, CT 06520-8025, USA. lynn.sullivan@yale.edu
authors.forename: Lynn E
authors.initials: LE
authors.lastname: Sullivan
authors.forename: Declan
authors.initials: D
authors.lastname: Barry
authors.forename: Brent A
authors.initials: BA
authors.lastname: Moore
authors.forename: Marek C
authors.initials: MC
authors.lastname: Chawarski
authors.forename: Jeanette M
authors.initials: JM
authors.lastname: Tetrault
authors.forename: Michael V
authors.initials: MV
authors.lastname: Pantalon
authors.forename: Patrick G
authors.initials: PG
authors.lastname: O'Connor
authors.forename: Richard S
authors.initials: RS
authors.lastname: Schottenfeld
authors.forename: David A
authors.initials: DA
authors.lastname: Fiellin
mesh_terms: D000286:Administration, Sublingual; D000328:Adult; D023241:Antiretroviral Therapy, Highly Active; D002047:Buprenorphine / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D015658:HIV Infections / Q000150:complications / Q000175:diagnosis* / Q000188:drug therapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D009270:Naloxone / Q000008:administration & dosage*; D009292:Narcotic Antagonists / Q000008:administration & dosage*; D009293:Opioid-Related Disorders / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D010865:Pilot Projects; D011336:Probability; D012016:Reference Values; D012307:Risk Factors; D016896:Treatment Outcome
chemical_list: D009292:Narcotic Antagonists; D009270:Naloxone; D002047:Buprenorphine