Naltrexone shortened opioid detoxification with buprenorphine

This double-blind, randomized, placebo-controlled clinical trial evaluated the impact on withdrawal symptoms of (i) combining naltrexone with a 4-day buprenorphine taper for short opioid detoxification (NB Group), compared to (ii) using a 4-day buprenorphine taper alone, followed by naltrexone on da y 8 (PB Group). Sublingual buprenorphine was administered on days 1-4 (26 m g total). For the NE Group (n = 32) escalating doses of oral naltrexone wer e given on days 2-8 (placebo day i). For the PB Group (n = 28) placebo was given on days 1-7 and naltrexone on day 8. Main outcome measures were Obser ved Opioid Withdrawal scores (OOW, 0-30) and use of medications to treat op ioid withdrawal. Of 32 patients in the NE group, 59% experienced clinically relevant withdrawal (defined as OOW greater than or equal to 5) on day 2, but, after day 5, none experienced withdrawal. In the PB group, the number of patients experiencing withdrawal increased over time. The first naltrexo ne dose induced comparable withdrawal in both groups: peak OOW scores were (mean +/- SD) 5.2 +/- 3.3 on day 2 for the NE group, and 4.0 +/- 3.9 on day 8 for the PB group (NS), though, on day 2, 7 patients dropped out in the N E group and none in the PB group, while only one patient dropped out in the PB group on day 8. Throughout the 8-day study, patients in both groups rec eived similar amount of adjunct medication: 0.64 +/- 0.07 mg (NB group) of clonidine vs 0.73 +/- 0.15 mg (PB group; NS). Only 25% of patients required use of sedatives (up to 20 mg diazepam). Starting naltrexone on day 2 appe ared to abolish withdrawal symptoms after day 5 and, thus, to shorten the d uration of withdrawal symptoms. Peak withdrawal symptoms after naltrexone w ere of moderate intensity, suggesting that naltrexone combined with bupreno rphine is an acceptable and safe treatment for shortened opioid detoxificat ion and induction of naltrexone maintenance. (C) 1999 Elsevier Science Irel and Ltd. All rights reserved.