Superiority of Buprenorphine over Suboxone in Preventing Addiction Relapse in Opioid Addicts under Maintenance Therapy: A Double-Blind Clinical Trial

Background: In maintenance therapy for opioid addiction, to reduce the risk of buprenorphine (BUP) abuse, the combination of BUP and naloxone (NX) has been developed and is commercially available as suboxone (BUP/NX). This study was designed to compare addiction relapse frequency in patients receiving BUP and BUP/NX as maintenance therapy. Methods: In this double-blind clinical trial with cross over design, 100 opioid abusers were randomly assigned to two treatment groups to receive either BUP or BUP/NX. After three months, without a time-out period, subjects undertook treatment with the other drug. The subjects were screened weekly for urinary morphine. Results: In each of the study arms, when the patients were given BUP/NX, the number of relapses was significantly higher compared to when they received BUP (0.13±0.24 vs. 0.04±0.09, P = 0.001). If participants’ age was taken into account, the number of relapses was significantly higher when BUP/NX was given in age groups of 31 to 40 years and over 50 years (P < 0.05). The length of addiction had also a significant impact on the number of relapses, i.e., patients with over 10-year history of addiction had higher number of relapses if they were given BUP/NX compared with BUP (P < 0.05). Conclusion: BUP seems to be more effective than BUP/NX in preventing addiction relapse in opioid abusers under maintenance treatment.