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Wiley InterScience | ||||
  AddictionVolume 102 Issue 10, Pages 1648 - 1656 Published Online: 9 Aug 2007 Journal compilation © 2010 Society for the Study of Addiction Published on behalf of the Society for the Study of Addiction
Abstract | References | Full Text: HTML, PDF (Size: 275K) | Related Articles | Citation Tracking  RESEARCH REPORT Evaluation of a transdermal buprenorphine formulation in opioid detoxification Copyright © 2007 The Authors. Journal compilation © 2007 Society for the Study of Addiction KEYWORDS Buprenorphine • detoxification • opioid • patch • transdermal • withdrawal ABSTRACTAims Buprenorphine is marketed in a sublingual formulation for treatment of opioid dependence. A transdermal formulation has been developed that may provide extended relief from opioid withdrawal, reduce required clinic visits and improve adherence, while having less potential for diversion and abuse. This study evaluated the safety and biodelivery (blood levels) of this transdermal buprenorphine formulation (i.e. buprenorphine patch), and its apparent efficacy in suppressing the opioid withdrawal syndrome. Design Open-label, first-in-humans trial. Setting A residential research facility. Participants Nine physically dependent opioid-users completed the 10-day opioid detoxification study. Intervention Each volunteer received a single patch application that remained in place for 3 days. The formulation has shown an average delivery of 1.9 mg/day of buprenorphine over 3 days in pre-clinical evaluation. Measures Physiological, behavioral, subjective and observer ratings of opioid withdrawal and opioid agonist effects were collected. Findings Overall, the patch appeared safe and well tolerated. There were no serious adverse events, and no opioid intoxication following patch application. Oxygen saturation, heart rate, blood pressure, skin temperature and pupil diameter remained well within normal ranges. Buprenorphine blood levels peaked 48 hours after patch application at a concentration of 0.60 ng/ml. Volunteers' self-reports of the presence and severity of withdrawal symptoms were reduced by approximately 50% on the 3 days of patch application. Withdrawal symptoms increased marginally upon patch removal. Administration of opioid rescue medication was eliminated within 6 hours of patch application, and increased slightly upon patch removal. Conclusions The significant biodelivery of buprenorphine and the suppression of the opioid withdrawal syndrome during patch application and its reappearance after patch removal indicate clinically useful pharmacodynamic activity. Transdermal buprenorphine may be a useful opioid detoxification treatment that reduces compliance concerns, and delivers buprenorphine in a formulation less likely to be diverted to illicit use. Submitted 12 December 2006; initial review completed 5 March 2007; final version accepted 8 May 2007 | 
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