Corresponding Author: Bankole A. Johnson, DSc, MD, PhD, Department of Psychiatry and Neurobehavioral Sciences, University of Virginia, PO Box 800623, Charlottesville, VA 22908 ([email protected]).
Author Contributions: Dr Johnson 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. Drs Anton, Ciraulo, Kranzler, Mann, O'Malley, and Swift contributed equally as coauthors.
Study concept and design: Johnson, Rosenthal, Capece, Beyers.
Acquisition of data: Johnson, Capece, Wiegand, Beyers, McKay, Ait-Daoud, Anton, Ciraulo, Kranzler, O'Malley, Swift.
Analysis and interpretation of data: Johnson, Rosenthal, Capece, Wiegand, Mao, Ait-Daoud, Anton, Ciraulo, Kranzler, Mann, O'Malley, Swift.
Drafting of the manuscript: Johnson, Rosenthal.
Critical revision of the manuscript for important intellectual content: Johnson, Capece, Wiegand, Mao, Beyers, McKay, Ait-Daoud, Anton, Ciraulo, Kranzler, Mann, O'Malley, Swift.
Statistical analysis: Johnson, Rosenthal, Wiegand, Mao.
Obtained funding: Johnson, Rosenthal, Capece, Wiegand.
Administrative, technical, or material support: Johnson, Capece, Wiegand, Beyers, McKay, Ait-Daoud, Anton, Ciraulo, Kranzler, Mann, O'Malley, Swift.
Study supervision: Johnson, Rosenthal, Capece, Wiegand, McKay, Ait-Daoud.
Financial Disclosures: Dr Johnson reported being a consultant for Ortho-McNeil Janssen Scientific Affairs LLC, Organon, and TransOral Pharmaceuticals Inc. Drs Rosenthal, Wiegand, Mao, and McKay and Mss Capece and Beyers reported being employees of Ortho-McNeil Janssen Scientific Affairs LLC. Dr Ait-Daoud reported being a consultant for Ortho-McNeil Janssen Scientific Affairs LLC. Dr Anton reported receiving consulting fees from AstraZeneca, Axis Shield, Cephalon, DrugAbuse Sciences, Sanofi-Aventis, Eli Lilly, and Solvay Pharmaceuticals; consulting fees and honoraria from Forest Laboratories and Alkermes Inc; consulting fees and grants from Bristol-Myers Squibb, Hythiam, and Pfizer; and consulting fees, honoraria, and grants from Contral Pharma/Biotie Pharmaceuticals and Ortho-McNeil Janssen Scientific Affairs LLC. Dr Ciraulo reported receiving consulting fees and clinical trial contracts from Janssen, Bristol-Myers Squibb, and Ortho-McNeil Janssen Scientific Affairs LLC; consulting fees from Cephalon; and clinical trial contracts from Alkermes Inc, AstraZeneca, DrugAbuse Sciences, Lipha, UCB Pharma, and Catalyst Pharmaceutical Partners. Dr Kranzler reported serving as a consultant for and receiving research support from Alkermes Inc, Ortho-McNeil Janssen Scientific Affairs LLC, Bristol-Myers Squibb, Forest Pharmaceuticals, and DrugAbuse Sciences; and serving as a consultant for Elbion, Sanofi-Aventis, and Solvay Pharmaceuticals. Dr Mann reported receiving consulting fees and clinical trial contracts from Alkermes Inc, Janssen, Sanofi-Aventis, Pfizer, Lipha Pharmaceuticals, Ortho-McNeil Janssen Scientific Affairs LLC, and Forest Pharmaceuticals. Dr O'Malley reported serving as a consultant and receiving research support from Alkermes Inc, GlaxoSmithKline, Ortho-McNeil Janssen Scientific Affairs LLC, and Pfizer; serving as a consultant for Eli Lilly and Johnson & Johnson; receiving research support from Lipha Pharmaceuticals, Bristol-Myers Squibb, Sanofi-Aventis, and Mallinckrodt; and receiving travel reimbursement from Alkermes Inc. Dr Swift reported serving as a consultant for and receiving grant funding from Ortho-McNeil Janssen Scientific Affairs LLC and Pfizer; serving as a consultant and on speakers bureaus for Cephalon and Forest Laboratories; serving as a consultant for Alkermes Inc, Organon, and TransOral Pharmaceuticals Inc; and receiving grant funding from US World Meds and Bristol-Myers Squibb.
Funding/Support: Ortho-McNeil Janssen Scientific Affairs LLC provided the medication and funding for this study.
Role of the Sponsor: The sponsor was involved in all stages from study design through interpretation of the results including critical review of the manuscript. Data were managed initially and analyzed by Ortho-McNeil Janssen Scientific Affairs LLC and PharmaNet Inc, a contract research organization, and were interpreted by the study authors with input from Ortho-McNeil Janssen Scientific Affairs LLC clinical and statistical staff. An independent statistical analysis was performed by Daniel O. Scharfstein, ScD (see below). The entirety of the first draft was prepared by Dr Johnson. The draft was reviewed by all of the authors, who discussed it as a group at a scheduled meeting of the Topiramate for Alcoholism Advisory Board (see below) in New York on February 2, 2007. Amendments pertained to style and presentation, and no changes were made by the sponsor to the results or their interpretation from the initial draft or the results as presented at that meeting.
Independent Statistical Analysis: Daniel O. Scharfstein, ScD, conducted an independent statistical analysis at the Johns Hopkins University Bloomberg School of Public Health. Dr Scharfstein had access to the entire raw data set, study protocol, and prespecified plan for data analysis. Dr Scharfstein confirmed the accuracy and validity of the data and results presented in this article. He received compensation from Ortho-McNeil Janssen Scientific Affairs LLC to perform this independent statistical evaluation.
Topiramate for Alcoholism Study Group (by principal investigator and participating site and in alphabetical order): Nassima Ait-Daoud, MD (University of Virginia, Charlottesville), Robert M. Anthenelli, MD (University of Cincinnati, Cincinnati, Ohio), Raymond F. Anton, MD (Medical University of South Carolina, Charleston), Marianne Guschwan, MD (New York Veterans Affairs Medical Center, New York), Bankole A. Johnson, DSc, MD, PhD, MPhil, FRCPsych (University of Texas Health Science Center, San Antonio), Henry R. Kranzler, MD (University of Connecticut, Farmington), Sandra C. Lapham, MD (Behavioral Health Research Center of the Southwest, Albuquerque, New Mexico), Francis Levin, MD (Columbia University, New York, New York), Lance Longo, MD (Aurora Sinai Medical Center, Milwaukee, Wisconsin), F. Gerard Moeller, MD (University of Texas Health Science Center, Houston), Stephanie S. O'Malley, PhD (Yale University, New Haven, Connecticut), Helen M. Pettinati, PhD (University of Pennsylvania, Philadelphia), Ihsan Salloum, MD, MPH (University of Pittsburgh, Pittsburgh, Pennsylvania), Ofra Sarid-Segal, MD (Boston University, Boston, Massachusetts), Robert M. Swift, MD, PhD (Brown University, Providence, Rhode Island), Richard P. Trautman, MD (University of Oklahoma, Oklahoma City), and Roger D. Weiss, MD (McLean Hospital, Belmont, Massachusetts).
Topiramate for Alcoholism Advisory Board (in alphabetical order): Giovanni Addolorato, MD (Catholic University, Rome, Italy), Nassima Ait-Daoud, MD (University of Virginia, Charlottesville), Raymond F. Anton, MD (Medical University of South Carolina, Charleston), Domenic A. Ciraulo, MD (Boston University, Boston, Massachusetts), Carlo C. DiClemente, PhD (University of Maryland, Baltimore County), Scott E. Hemby, PhD (Wake Forest University, Winston-Salem, North Carolina), Eric Hollander, MD (Mount Sinai School of Medicine, New York, New York), Bankole A. Johnson, DSc, MD, PhD, MPhil, FRCPsych (University of Virginia, Charlottesville), Falk Kiefer, MD (University Hospital of Hamburg, Hamburg, Germany), Henry R. Kranzler, MD (University of Connecticut, Farmington), Otto M. Lesch, MD (Medical University of Vienna, Vienna, Austria), Robert J. Malcolm Jr, MD (Medical University of South Carolina, Charleston), Karl Mann, MD (University of Heidelberg, Mannheim, Germany), Stephanie S. O'Malley, PhD (Yale University, New Haven, Connecticut), and Robert M. Swift, MD, PhD (Brown University, Providence, Rhode Island).
Additional Contributions: The staff at the participating sites provided skilled technical assistance. Robert H. Cormier Jr, BA, and Chamindi Seneviratne, MD, provided assistance in preparing the manuscript. Both Mr Cormier and Dr Seneviratne are employed by the University of Virginia and were compensated for their contributions as part of their normal salaries.
