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Medical treatments for opioid use disorder in Iran: a randomized, double‐blind placebo‐controlled comparison of buprenorphine/naloxone and naltrexone maintenance treatment
Author(s) -
Mokri Azarakhsh,
Chawarski Marek C.,
Taherinakhost Hamidreza,
Schottenfeld Richard S.
Publication year - 2016
Publication title -
addiction
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.424
H-Index - 193
eISSN - 1360-0443
pISSN - 0965-2140
DOI - 10.1111/add.13259
Subject(s) - medicine , buprenorphine , naltrexone , opioid use disorder , abstinence , (+) naloxone , randomized controlled trial , placebo , confidence interval , opioid , anesthesia , clinical trial , psychiatry , receptor , alternative medicine , pathology
Aims 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). Design Twelve‐week single‐site, two‐group parallel randomized double‐blind clinical trial. Setting An out‐patient clinical research program in Tehran, Iran. Participants Following medically assisted withdrawal, participants with opioid use disorder were assigned randomly to NTX ( n = 51) or BNX ( n = 51). Intervention Medications were administered three times per week, double‐blind, double‐dummy for 12 weeks. All participants received weekly group drug counseling. Measurements 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. Findings 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.