Study design
OI
SECONDARY
This was a secondary analysis of a randomized, double-blind, placebo-controlled study which enrolled treatment-seeking adults who met the Phase 3 study design. After screening, participants entered an open-label run-in phase of up to 2 weeks of treatment with buprenorphine/naloxone sublingual film (induction and stabilization), to achieve daily doses ranging from 8 mg/2 mg to 24 mg/6 mg. After run-in, Eligible participants were then randomly assigned (4:4:1:1) to receive BUP-XR 300 mg/300 mg, BUP-XR 300 mg/100 mg, or volume-matched placeboEach participant’s usual route of opioid use was documented. If more than 1 route was frequently used, then the most severe of those was chosen as the usual route based on the following ranking from least to most severe: oral, nasal, smoking, and injection. Participants whose usual route of opioid use at screening was via injection were classified as opioid-injecting participants (OI), and participants who did not use injection as the usual route of opioid use at screening were classified as non-injecting opioid participants (NIO); herein, we refer to OI and NIO as “populations.”The study was conducted in accordance with principles and requirements of the International Council for Harmonization Good Clinical Practice guidelines and the principles of the Declaration of Helsinki. Written informed consent was obtained from all participants prior to study-related procedures. The clinical study protocol, informed consent forms, and all other appropriate study-related documents were reviewed and approved by Quorum Review Institutional Review Board.