Home > A prospective, randomized, multicenter acceptability and safety study of direct buprenorphine/naloxone induction in heroin-dependent individuals.

Amass, Leslie and Pukeleviciene, Vilma and Subata, Emilis and Almeida, Antonio Rocha and Pieri, Maria Chiara Pieri and D'Egidio, Pietro and Stankova, Zdenka and Costa, Antonio and Smyth, Bobby P and Sakoman, Slavko and Wei, Yan and Strang, John (2012) A prospective, randomized, multicenter acceptability and safety study of direct buprenorphine/naloxone induction in heroin-dependent individuals. Addiction , 107 , (1) , pp. 142-151.

Aims: To provide controlled data on direct induction with buprenorphine/naloxone (BNX) vs indirect buprenorphine (BPN)-to-BNX induction.

Design: Phase 4, prospective, randomized, active-drug controlled, parallel-group trial consisting of a 2-day, double-blind, double-dummy induction phase followed by 26 days of open-label treatment with BNX.

Setting: 19 sites in 10 European countries from March 2008 to December 2009.

Participants: 187 opioid-dependent men and women ≥15 years of age.

Measurements: The primary objective was assessment of patient response to direct and indirect BNX induction (proportion of patients receiving the scheduled 16-mg BNX dose on day 3 [i.e. first day post-induction]). Secondary assessments included illicit drug use, treatment retention and compliance, withdrawal scale scores, and safety.

Findings: Patient response to direct- versus indirect-BNX induction was similar (direct 91.4% [85/93] versus indirect 90.4% [85/94]; 95%CI, -7.3%, 9.2%). Rapid dose induction (16 mg of buprenorphine equivalent on day 2) was acceptable and >70% of patients within each group completed treatment (day 28). There were no significant differences in secondary measures across groups. An average BNX maintenance dose of 15.3 mg across groups was associated with substantial reductions in illicit opioid use and no self-reported intravenous misuse. Treatment compliance and retention rates were similar (99% and 81%, respectively). Treatment-emergent adverse event rates were comparable: 75% vs 74% for direct- versus indirect-induction groups, respectively.

Conclusions: Direct BNX induction was a safe and effective strategy for maintenance treatment of opioid dependence. Response to high-dose direct BNX induction appears to be similar to indirect BPN-to-BNX induction and was not associated with reports of intravenous BNX misuse.


Item Type:Article
Date:2012
Page Range:pp. 142-151
Publisher:Wiley
Volume:107
Number:1
EndNote:View
Accession Number:HRB (Not in collection)
Related URLs:
Subjects:B Substances > Opioids (opiates) > Opioid product > Naloxone
B Substances > Opioids (opiates) > Opioid product > Buprenorphine / Suboxone
HJ Treatment method > Substance disorder treatment method > Substance disorder drug therapy
HJ Treatment method > Substance disorder treatment method > Substance replacement method (substitution)
VA Geographic area > International aspects
VA Geographic area > Europe > Ireland

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