title: Buprenorphine implants for treatment of opioid dependence: randomized comparison to placebo and sublingual buprenorphine/naloxone.
abstract: OBJECTIVE
  To evaluate the safety and efficacy of buprenorphine implants (BI) versus placebo implants (PI) for the treatment of opioid dependence. A secondary aim compared BI to open-label sublingual buprenorphine/naloxone tablets (BNX).
  
  
  METHODS
  Randomized, double-blind, placebo-controlled trial. Subjects received either four buprenorphine implants (80 mg/implant) (n = 114), four placebo implants (n = 54) or open-label BNX (12-16 mg/day) (n = 119).
  
  
  METHODS
  Twenty addiction treatment centers.
  
  
  METHODS
  Adult out-patients (ages 18-65) with DSM-IV-TR opioid dependence.
  
  
  METHODS
  The primary efficacy end-point was the percentage of urine samples negative for opioids collected from weeks 1 to 24, examined as a cumulative distribution function (CDF).
  
  
  RESULTS
  The BI CDF was significantly different from placebo (P < 0.0001). Mean [95% confidence interval (CI)] proportions of urines negative for opioids were: BI = 31.2% (25.3, 37.1) and PI = 13.4% (8.3, 18.6). BI subjects had a higher study completion rate relative to placebo (64 versus 26%, P < 0.0001), lower clinician-rated (P < 0.0001) and patient-rated (P < 0.0001) withdrawal, lower patient-ratings of craving (P < 0.0001) and better subjects' (P = 0.031) and clinicians' (P = 0.022) global ratings of improvement. BI also resulted in significantly lower cocaine use (P = 0.0016). Minor implant-site reactions were comparable in the buprenorphine [27.2% (31 of 114)] and placebo groups [25.9% (14 of 54)]. BI were non-inferior to BNX on percentage of urines negative for opioids [mean (95% CI) = 33.5 (27.3, 39.6); 95% CI for the difference of proportions = (-10.7, 6.2)].
  
  
  CONCLUSIONS
  Compared with placebo, buprenorphine implants result in significantly less frequent opioid use and are non-inferior to sublingual buprenorphine/naloxone tablets.
authors.affiliation: Department of Psychiatry, St. Luke's-Roosevelt Hospital Center, Columbia University College of Physicians and Surgeons, New York, NY, USA.
authors.forename: Richard N
authors.initials: RN
authors.lastname: Rosenthal
authors.forename: Walter
authors.initials: W
authors.lastname: Ling
authors.forename: Paul
authors.initials: P
authors.lastname: Casadonte
authors.forename: Frank
authors.initials: F
authors.lastname: Vocci
authors.forename: Genie L
authors.initials: GL
authors.lastname: Bailey
authors.forename: Kyle
authors.initials: K
authors.lastname: Kampman
authors.forename: Ashwin
authors.initials: A
authors.lastname: Patkar
authors.forename: Steven
authors.initials: S
authors.lastname: Chavoustie
authors.forename: Christine
authors.initials: C
authors.lastname: Blasey
authors.forename: Stacey
authors.initials: S
authors.lastname: Sigmon
authors.forename: Katherine L
authors.initials: KL
authors.lastname: Beebe
mesh_terms: D000286:Administration, Sublingual; D000293:Adolescent; D000328:Adult; D000368:Aged; D002047:Buprenorphine / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004343:Drug Implants; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009270:Naloxone / Q000008:administration & dosage* / Q000009:adverse effects; D009292:Narcotic Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D058850:Opiate Substitution Treatment / Q000379:methods; D009293:Opioid-Related Disorders / Q000188:drug therapy*; D013607:Tablets; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D004343:Drug Implants; D009292:Narcotic Antagonists; D013607:Tablets; D009270:Naloxone; D002047:Buprenorphine
keywords: Buprenorphine; drug addiction; drug implants; maintenance therapy; opioid dependence; treatment adherence
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