Comparisons of Analgesic Potency and Side Effects of Buprenorphine and Buprenorphine With Ultra-low-dose Naloxone

Objectives: Opioids are the most effective pain medication available, yet concerns about their safety may limit their administration to those in need. In efforts to identify analgesics with lower potential for abuse and dependence, recent evidence suggests that combinations of opioids with ultra-low doses of the opioid antagonist naloxone may enhance the analgesic effect with increased safety. This study investigated the use of buprenorphine (0.3 mg) plus ultra-low-dose naloxone (0.02 mg) (BUP + ULDN) as compared with buprenorphine alone (0.3 mg) (BUP) for the treatment of pain. Methods: In a double-blind, placebo-controlled, randomized crossover design, 12 study participants with lingering, noncancer pain received each medication intravenously for 5 days of dosing, separated by an intertrial interval of at least 7 days to avoid possible carryover effects. Results: We found no order effects and no differences between medications in pre- to postdose pain ratings, side effects, or adverse events. Conclusions: These findings suggest that BUP + ULDN is not more effective in reducing pain than BUP.