title: Medical treatments for opioid use disorder in Iran: a randomized, double-blind placebo-controlled comparison of buprenorphine/naloxone and naltrexone maintenance treatment.
abstract: OBJECTIVE
  With the broad goals of developing a clinical research and training program and disseminating effective opioid use disorder treatments in Iran, this pilot clinical trial compared the effectiveness of oral naltrexone (NTX) and sublingual buprenorphine/naloxone (BNX).
  
  
  METHODS
  Twelve-week single-site, two-group parallel randomized double-blind clinical trial.
  
  
  METHODS
  An out-patient clinical research program in Tehran, Iran.
  
  
  METHODS
  Following medically assisted withdrawal, participants with opioid use disorder were assigned randomly to NTX (n = 51) or BNX (n = 51).
  
  
  METHODS
  Medications were administered three times per week, double-blind, double-dummy for 12 weeks. All participants received weekly group drug counseling.
  
  
  METHODS
  The primary outcome was initial duration of opioid abstinence verified by urine toxicology tests. Secondary outcomes included the number of opioid-negative urine tests, treatment retention and proportions with sustained, verified opioid-abstinence for 12 weeks.
  
  
  RESULTS
  Mean [95% confidence interval (CI)] number of days of initial duration of verified abstinence was 28.8 (20.0-37.5) with BNX and 21.6 (14.4-28.7) with NTX (P = 0.205). The mean (95% CI) number of opioid-negative urine tests was 19.7 (17.7-21.6) with BNX and 15.4 (13.1-17.8) with NTX (P = 0.049). The mean (95% CI) number of days in treatment was 70.6 (63.6-77.7) with BNX versus 56.5 (47.8-65.3) with NTX (P = 0.013). The rate of sustained, 12-week opioid abstinence was 16% (8/51) in the BNX group and 8% (4/51) in the NTX group (P = 0.219).
  
  
  CONCLUSIONS
  Among patients with opioid use disorder in Iran, sublingual buprenorphine/naloxone was associated with a greater number of opioid-negative urine tests and treatment retention than oral naltrexone, but not significantly greater initial abstinence duration or proportions with sustained abstinence.
authors.affiliation: Iranian National Center for Addiction Studies and Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Azarakhsh
authors.initials: A
authors.lastname: Mokri
authors.affiliation: Departments of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.
authors.forename: Marek C
authors.initials: MC
authors.lastname: Chawarski
authors.affiliation: Iranian National Center for Addiction Studies and Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Hamidreza
authors.initials: H
authors.lastname: Taherinakhost
authors.affiliation: Departments of Psychiatry, Yale University School of Medicine, New Haven, CT, USA.
authors.forename: Richard S
authors.initials: RS
authors.lastname: Schottenfeld
mesh_terms: D000328:Adult; D000553:Ambulatory Care; D000701:Analgesics, Opioid / Q000627:therapeutic use*; D000069479:Buprenorphine, Naloxone Drug Combination / Q000627:therapeutic use*; D003376:Counseling; D004311:Double-Blind Method; D006801:Humans; D007492:Iran; D009270:Naloxone / Q000627:therapeutic use*; D009292:Narcotic Antagonists / Q000627:therapeutic use*; D009293:Opioid-Related Disorders / Q000534:rehabilitation*; D015813:Substance Abuse Detection / Q000379:methods
chemical_list: D000701:Analgesics, Opioid; D000069479:Buprenorphine, Naloxone Drug Combination; D009292:Narcotic Antagonists; D009270:Naloxone
keywords: Buprenorphine; HIV/AIDS; naltrexone; opioid dependence; randomized clinical trial