Abstract
Objectives. To develop evidence-based practice guidelines for the pharmacological treatment of opioid abuse and dependence. Methods. An international task force of the World Federation of Societies of Biological Psychiatry (WFSBP) developed these practice guidelines after a systematic review of the available evidence pertaining to the treatment of opioid dependence. On the basis of the evidence, the Task Force reached a consensus on practice recommendations, which are intended to be clinically and scientifically meaningful for physicians who treat adults with opioid dependence. The data used to develop these guidelines were extracted primarily from national treatment guidelines for opioid use disorders, as well as from meta-analyses, reviews, and publications of randomized clinical trials on the efficacy of pharmacological and other biological treatments for these disorders. Publications were identified by searching the MEDLINE database and the Cochrane Library. The literature was evaluated with respect to the strength of evidence for efficacy, which was categorized into one of six levels (A–F). Results. There is an excellent evidence base supporting the efficacy of methadone and buprenorphine or the combination of buprenorphine and naloxone for the treatment of opioid withdrawal, with clonidine and lofexidine as secondary or adjunctive medications. Opioid maintenance with methadone and buprenorphine is the best-studied and most effective treatment for opioid dependence, with heroin and naltrexone as second-line medications. Conclusions. There is enough high quality data to formulate evidence-based guidelines for the treatment of opioid abuse and dependence. This task force report provides evidence for the efficacy of a number of medications to treat opioid abuse and dependence, particularly the opioid agonists methadone or buprenorphine. These medications have great relevance for clinical practice.
Acknowledgments
We would like to thank Jacquie Klesing, ELS, for editorial assistance with the manuscript and Leah Zindel, R.Ph., M.A.L.S. for her careful editorial review.
Statements of interest
Michael Soyka has received travel grants from Eli Lilly, Bristol-Myers Squibb and AstraZeneca, support for scientific studies from Sanofi-Aventis Essex and speakers’ fees from Prempharm and has worked as a consultant for Phoenux. Henry R. Kranzler has been a paid consultant for Alkermes, GlaxoSmithKline and Gilead. He has received research support from Merck. He also reports associations with Eli Lilly, Janssen, Schering Plough, Lundbeck, Alkermes, GlaxoSmithKline, Abbott, and Johnson & Johnson, as these companies provide support to the ACNP Alcohol Clinical Trials Initiative (ACTIVE) and Dr. Kranzler receives support from ACTIVE. Wim van den Brink has received travel grants from Eli Lilly, has been a paid consultant of Bristol-Myers Squibb and has been a study advisor for Lundbeck.
John Krystal has received grants or is a consultant for or on the advisory boards of Abbott Laboratories, Aisling Capital LLC, AstraZeneca Pharmaceuticals, Brintnall & Nicolini, Inc., Bristol-Myers Squibb, Easton Associates, Eisai Inc., Eli Lilly and Co., F. Hoffmann-La Roche Ltd, Gilead Sciences Inc., GlaxoSmithKline, Janssen Pharmaceuticals, Lohocla Research Corporation, Lundbeck Research USA, Medivation Inc., Merz Pharmaceuticals, MK Medical Communications, Naurex Inc., Pfizer Pharmaceuticals, SK Holdings Co. Ltd, Takeda Industries, Tetragenex Pharmaceuticals, Teva Pharmaceutical Industries Ltd.
Hans-Jürgen Möller has received grants or is a consultant for and on the speakership bureaus of AstraZeneca, Bristol-Myers Squibb, Eisai, Eli Lilly, GlaxoSmithKline, Janssen Cilag, Lundbeck, Merck, Novartis, Organon, Pfizer, Sanofi-Aventis, Schering-Plough, Schwabe, Sepracor, Servier and Wyeth.
Siegfried Kasper has received grant/research support from Bristol Myers-Squibb, Eli Lilly, GlaxoSmithKline, Lundbeck, Organon, Sepracor and Servier; has served as a consultant or on advisory boards for AstraZeneca, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Janssen, Lundbeck, Merck Sharp and Dome (MSD), Novartis, Organon, Pfizer, Schwabe, Sepracor, and Servier; and has served on speakers1 bureaus for Angelini, AstraZeneca, Bristol Myers-Squibb, Eli Lilly, Janssen, Lundbeck, Pfizer, Pierre Fabre, Schwabe, Sepracor, and Servier.