title: Primary care-based buprenorphine taper vs maintenance therapy for prescription opioid dependence: a randomized clinical trial.
abstract: OBJECTIVE
  Prescription opioid dependence is increasing and creates a significant public health burden, but primary care physicians lack evidence-based guidelines to decide between tapering doses followed by discontinuation of buprenorphine hydrochloride and naloxone hydrochloride therapy (hereinafter referred to as buprenorphine therapy) or ongoing maintenance therapy.
  
  
  OBJECTIVE
  To determine the efficacy of buprenorphine taper vs ongoing maintenance therapy in primary care-based treatment for prescription opioid dependence.
  
  
  METHODS
  We conducted a 14-week randomized clinical trial that enrolled 113 patients with prescription opioid dependence from February 17, 2009, through February 1, 2013, in a single primary care site.
  
  
  METHODS
  Patients were randomized to buprenorphine taper (taper condition) or ongoing buprenorphine maintenance therapy (maintenance condition). The buprenorphine taper was initiated after 6 weeks of stabilization, lasted for 3 weeks, and included medications for opioid withdrawal, after which patients were offered naltrexone treatment. The maintenance group received ongoing buprenorphine therapy. All patients received physician and nurse support and drug counseling.
  
  
  METHODS
  Illicit opioid use via results of urinanalysis and patient report, treatment retention, and reinitiation of buprenorphine therapy (taper group only).
  
  
  RESULTS
  During the trial, the mean percentage of urine samples negative for opioids was lower for patients in the taper group (35.2% [95% CI, 26.2%-44.2%]) compared with those in the maintenance group (53.2% [95% CI, 44.3%-62.0%]). Patients in the taper group reported more days per week of illicit opioid use than those in the maintenance group once they were no longer receiving buprenorphine (mean use, 1.27 [95% CI, 0.60-1.94] vs 0.47 [95% CI, 0.19-0.74] days). Patients in the taper group had fewer maximum consecutive weeks of opioid abstinence compared with those in the maintenance group (mean abstinence, 2.70 [95% CI, 1.72-3.75] vs 5.20 [95% CI, 4.16-6.20] weeks). Patients in the taper group were less likely to complete the trial (6 of 57 [11%] vs 37 of 56 [66%]; P < .001). Sixteen patients in the taper group reinitiated buprenorphine treatment after the taper owing to relapse.
  
  
  CONCLUSIONS
  Tapering is less efficacious than ongoing maintenance treatment in patients with prescription opioid dependence who receive buprenorphine therapy in primary care.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT00555425.
authors.affiliation: Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut.
authors.forename: David A
authors.initials: DA
authors.lastname: Fiellin
authors.affiliation: Department of Psychiatry, Yale University School of Medicine, New Haven, Connecticut.
authors.forename: Richard S
authors.initials: RS
authors.lastname: Schottenfeld
authors.affiliation: Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut.
authors.forename: Christopher J
authors.initials: CJ
authors.lastname: Cutter
authors.affiliation: Department of Psychiatry, Yale University School of Medicine, New Haven, Connecticut.
authors.forename: Brent A
authors.initials: BA
authors.lastname: Moore
authors.affiliation: Department of Psychiatry, Yale University School of Medicine, New Haven, Connecticut.
authors.forename: Declan T
authors.initials: DT
authors.lastname: Barry
authors.affiliation: Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut.
authors.forename: Patrick G
authors.initials: PG
authors.lastname: O'Connor
mesh_terms: D000328:Adult; D000701:Analgesics, Opioid / Q000652:urine; D002047:Buprenorphine / Q000008:administration & dosage*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D009292:Narcotic Antagonists / Q000008:administration & dosage*; D058850:Opiate Substitution Treatment / Q000379:methods*; D009293:Opioid-Related Disorders / Q000188:drug therapy* / Q000652:urine; D055553:Prescription Drugs; D011320:Primary Health Care / Q000379:methods*; D012008:Recurrence; D013375:Substance Withdrawal Syndrome / Q000517:prevention & control*; D016896:Treatment Outcome; D016482:Urinalysis
chemical_list: D000701:Analgesics, Opioid; D009292:Narcotic Antagonists; D055553:Prescription Drugs; D002047:Buprenorphine