P-56 * EFFICACY OF BUPRENORPHINE/NALOXONE COMBINATION IN REDUCING INTRAVENOUS MISUSE IN OPIOID-DEPENDENT PATIENTS (RIME STUDY)

Abstract

Aims. this study assesses the effectiveness of buprenorphine/naloxone combination in reducing intravenous (IV) misuse of buprenorphine in opioid-dependent patients. Methods. 158 patients >= 18 years, who misused buprenorphine intravenously >= 4 times/week and treated for opioid dependency with buprenorphine ( >= 2 mg/day dose) for >= 3 months were included in a multicenter, open-label, randomized controlled trial. They were required to report IV misuse in a daily diary. Randomization was 1:1 (buprenorphine/naloxone, n = 79: buprenorphine, n = 79). The trial was including a 3-month randomized treatment period with a follow-up optional 9-month treatment period for those who chose to continue receiving buprenorphine/naloxone. Results. the primary outcome was the percentage of patients achieving >= 30% reduction in the mean number of weekly study drug injections throughout the randomized treatment period compared with baseline: 89.6% (n = 67) and 45.8% (n = 59) (p <0.0001) of patients in the buprenorphine/naloxone and buprenorphine groups, respectively. In the buprenorphine/naloxone group, 74.2% of patients stopped injecting the study drug compared to 15.9% in the buprenorphine group (p < 0.0001). Of those patients injecting the study drug, patients misusing buprenorphine/naloxone (n = 44) reported significantly less disagreeable side effects than the buprenorphine group (n = 71) (p < 0.0001). Buprenorphine/naloxone combination is significantly effective in reducing IV misuse of buprenorphine in opioid-dependent patients.