Author Contributions: Dr Woody had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Woody, Poole, Forman, McNicholas, Blaine, Lynch, Fudala.
Acquisition of data: Woody, Poole, Subramaniam, Bogenschutz, Abbott, Patkar, Publicker, McCain, Potter, Forman, Vetter, Lynch.
Analysis and interpretation of data: Woody, Poole, Dugosh, Bogenschutz, Patkar, McCain, Vetter, McNicholas, Lynch, Fudala.
Drafting of the manuscript: Woody, Poole, Subramaniam, Dugosh, McCain, Lynch.
Critical revision of the manuscript for important intellectual content: Woody, Poole, Subramaniam, Bogenschutz, Abbott, Patkar, Publicker, Potter, Forman, Vetter, McNicholas, Blaine, Fudala.
Statistical analysis: Dugosh, Lynch, Poole.
Obtained funding: Woody, Forman.
Administrative, technical, or material support: Woody, Poole, Subramaniam, Bogenschutz, Abbott, Patkar, Publicker, McCain, Potter, Forman, Vetter, Blaine, Lynch, Fudala.
Study supervision: Woody, Poole, Abbott, Patkar, McCain, Forman, Vetter, McNicholas, Lynch.
Financial Disclosures: Dr Woody reported being a member of the RADARS postmarketing study external advisory group whose job is to assess abuse of prescription medications. Denver Health administers RADARS and Abbott, Cephalon, Endo, Pricara/Ortho-NcNeil, Purdue Pharma, and Shire subscribe to its data. Dr Woody reported that Ortho-McNeil and Purdue Pharma funded similar work by him prior to his joining RADARS. Dr Woody reported that Schering-Plough, the European distributor for buprenorphine-naloxone, funded his travel costs to meetings in Sweden and Finland in June 2008 to present data from this study. Dr Bogenschutz reported receiving research funding from Forest and Lilly and having a confidentiality agreement with Lilly. Dr Forman reported being a faculty member at the University of Pennsylvania and co–principal investigator with Dr Woody on the Delaware Valley Node of the NIDA Clinical Trials Network until December 2005 when he joined Alkermes. Dr Patkar reported being a consultant to Bristol-Meyers Squibb, GlaxoSmithKline, and Reckitt Benckiser and being on the speakers' bureau for and receiving honoraria from Bristol-Meyers Squibb, Forest, GlaxoSmithKline, Janssen, Jazz Pharmaceuticals Lundbeck, McNeil Consumer & Specialty Inc, Organon, and Pfizer. Dr Publicker reported having been a speaker for Cephalon, Forest, and Reckitt Benckiser. Dr McNicholas reported having conducted training programs to certify physicians in the use of buprenorphine. Her expenses have been paid by unrestricted grants to universities that were often provided by Reckitt Benckiser. Dr Fudala reported having been employed by the University of Pennsylvania and Philadelphia VA Medical Center from 1991 until he joined Reckitt Benckiser in June 2005 and reported having been a consultant to Johnson & Johnson and Purdue Pharma.
Funding/Support: This study was supported by the following grants from the National Institute on Drug Abuse: U10-DA013711 to Duke University (Dr Patkar); U10-DA015831 to Harvard University (Dr Weiss); U10-DA13034 to Johns Hopkins University (Dr Stitzer); K12-DA000357 (Dr Subramaniam); U10-DA1533 to the University of New Mexico (Dr Miller); and U10-DA13043 and KO5-DA17009 (Dr Woody). Reckitt Benckiser provided medication for the study.
Role of Sponsor: The protocol review committee of the Clinical Trials Network (CTN) of the National Institute on Drug Abuse provided guidance and final approval for the study design. The director and deputy director of the Center for the Clinical Trials Network (CCTN), the data and safety monitoring board of the CCTN, the operations coordinating committee of the CTN, and quarterly site visits from a subcontractor to the CCTN monitored the conduct, data collection, and data management. The publications committee of the CTN gave final approval of the analysis and interpretation of the data and approved the manuscript. Reckitt Benckiser provided medication for the study.
Additional Contributions: Charles P. O’Brien, MD, PhD, provided administrative support; Doreen Cardillo provided technical support for research staff; Cynthia Clark, CRNP, designed case report forms; Chris Petro, MA, developed the Web-based system that was used for data collection (all at University of Pennsylvania). Howard Moss, MD, provided suggestions for outcome measures (Philadelphia VA Medical Center; now with the National Institute on Alcohol and Alcohol Abuse, Rockville, Maryland). A. Thomas McLellan, PhD, provided critical review of the manuscript (Treatment Research Institute and University of Pennsylvania). The following provided additional medical support at their sites: Hilary Connery, MD, and Edward McCarthy, MD (Mercy Recovery); Marc Fishman, MD (Mountain Manor); and Robert Kushner, MD (University of New Mexico Addiction and Substance Abuse Programs). The following Principal Investigators provided administrative support for study teams at their sites: Leonard Handlesman, MD (Duke University; now deceased); William A. Miller, PhD (University of New Mexico); Maxine Stitzer, PhD (Johns Hopkins); and Roger Weiss, MD (Harvard University).
The following individuals collected data at participating sites: Hilary S. Connery, MD, PhD; Jennifer Sharpe Potter, PhD, MPH; and Scott Provost, MM, MSW, McLean Hospital Alcohol and Drug Abuse Treatment Program; Michael Bogenschutz, MD; Wendy Johnson, Robert Kushner, MD; Craig L. Pacheco, MS; Patrick Abbott, MD; Meredith Pampell, Marilyn W. Diener, RN; Dinah Lopez, LPN; Socorro Lopez-Mazon, RN; Anna Maria Padilla Morgan, MA; and Gloria A. White, RN, University of New Mexico Center on Alcoholism, Substance Abuse and Addictions; Leonard Pena, Matthew Lujan, Jafet Gonzalez, MD; Danny Jaramillo, Gabriella Ortiz, RN; and Edna Gonzales, RN, Ayundantes; Botonya Harris, Brandy Alsop, Janice Sneed, MHS, CADC; Joe Glick, MD; Kimberly Fisher, LPN; Maria C. Mancuso, MD; Michele S. Hofstetter, LPN; Pamela D. Stearn, MS; Stuart Narrod, MD; Thelma K. Malone, RN, CD, MHS; and Tracey Dale, LPN, NCCDN, Brandywine Treatment Center; Ashwin Patkar, MD; Emily Brickman, Florine Melvin, Karen McCain, MSN, FNP; Kevin D. Watkins, Leonard Handlesman, MD; Melissa Williams, Neena Ajwani, Peggy Arias, RN; Renita Woodall, and Roxanne Ellington, LCAS, Duke Psychiatry–Duke Addictions Programs; Thomas E. Allen, LCSW, LADC; Sarah Braun, Christine C. Evans, RNC, CARN; Christopher Coose, MS, LADC; Edward A. McCarthy, MD; Elizabeth K. Clay, RN; Lisa DiPietro, RN; Mark Publicker, MD; Sally Van Snepson, PA-C, LAc, MS; and Burma Wilkins, Mercy Addiction Treatment Clinic; Adrienne N. Dixon, MS, PA-C; Amber M. Harris, BA; Angie Wu, RN; Carligher Long, Cindy Voss, Elsie Lopez, LPN; Geetha Subramaniam, MD; Marc Fishman, MD; Paul Harrell III, and Shannon Garrett, MSW, Mountain Manor Treatment Clinic. None of those listed received funding for this work other than full or partial salary from the National Institute on Drug Abuse for their work on the study.