Author Contributions: Drs Ling and Casadonte had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Study concept and design: Beebe, Ling, Casadonte.
Acquisition of data: Beebe.
Analysis and interpretation of data: Ling, Casadonte, Bigelow, Kampman, Patkar, Bailey, Rosenthal, Beebe.
Drafting of the manuscript: Ling, Casadonte, Bigelow, Kampman, Patkar, Bailey, Rosenthal, Beebe.
Critical revision of the manuscript for important intellectual content: Ling, Beebe, Patkar.
Statistical analysis: Beebe.
Obtained funding: Beebe.
Administrative, technical, or material support: Beebe.
Study supervision: Beebe, Ling, Casadonte.
Financial Disclosures: Dr Ling reports receiving research support from Reckitt Benckiser, Titan, and Hythiam; speaker fees from Reckitt Benckiser; and is a member of the Advisory Board of US World Med. Dr Casadonte reports being a paid mentor in the Physician Clinical Support System for training physicians in buprenorphine and his university has received research support from Titan. Dr Bigelow reports no conflicts relevant to this study. In recent years he has received consulting payments from Abbott Laboratories, Acura Pharmaceuticals, Takeda Pharmaceuticals, and Teva Pharmaceuticals, and through his university has received research support from Titan and Pain Therapeutics Inc. Dr Kampman reports receiving honoraria from Reckitt Benckiser and through his University has received research support from Titan. Dr Patkar reports receiving research grant support from the National Institutes of Health, Substance Abuse and Mental Health Services Administration, AstraZeneca, Bristol-Myers Squibb, Cephalon, Forest, GlaxoSmithKline, J & J, Jazz Pharmaceuticals, Lundbeck, McNeil Inc, Organon, Pfizer, Shire, and Titan Pharmaceuticals; having been a consultant to Bristol-Myers Squibb, GlaxoSmithKline, Cephalon/Alkermes, and Reckitt Benckiser; and having been on the speaker's bureau for Bristol-Myers Squibb, Cephalon, Alkermes, Merck, Pfizer, and Reckitt Benckiser. Dr Bailey reports having been on the speaker's bureaus of Forest and Pfizer and having received research support from Titan and Alkermes. Dr Rosenthal reports receiving research support from National Institute on Drug Abuse and Titan. Dr Beebe is an employee of Titan Pharmaceuticals.
Funding/Support: This study was funded by Titan Pharmaceuticals.
Role of the Sponsors: Data were collected and monitored by Titan Pharmaceuticals and INC Research Inc, a contract research organization. Titan Pharmaceuticals personnel were involved in the design of the study; management, analysis, and interpretation of the data; and preparation, review, and approval of the manuscript.
Independent Statistical Analysis: All efficacy and primary safety results and conclusions presented in this article have been confirmed by an independent statistical review and analysis performed by Jacqueline Johnson, DrPH, Assistant Professor of Psychiatry at the University of North Carolina, Chapel Hill. Dr Johnson was provided all raw SAS data sets, analysis SAS data sets, the study protocol containing a statistical analytical plan, a blank copy of the study case report forms, and the original version of the manuscript by the authors and sponsor of the trial. Dr Johnson was in agreement with the statistical methods used in the manuscript and independently verified the primary and secondary efficacy and safety results presented in the final manuscript. Dr Johnson was compensated by Titan Pharmaceuticals for her independent statistical review.
Additional Contributions: We thank the following study investigators: Michael Banov, MD, Northwest Behavioral Research Center, Roswell, Georgia; William Dickinson, DO, Providence Behavioral Health Services, Everett, Washington; David Flaherty, DO, Fidelity Clinical Research Inc, Lauderhill, Florida; Mark Greenwald, PhD, Wayne State University School of Medicine, Department of Psychiatry and Behavioral Neuroscience, Detroit, Michigan; Valentin Isacescu, MD, North County Clinical Research, Oceanside, California; Saleem Ishaque, MD, Synergy Clinical Research Center, National City, California; Azfar Malik, PsychCare Consultants Research, St Louis, Missouri; Jorg Pahl, MD, Pahl Clinical Research Professionals, Oklahoma City, Oklahoma. We also thank Edward Schweizer, MD, of Paladin Consulting Group, San Mateo, California, who provided assistance with the drafting of the manuscript, and Titan Pharmaceuticals employees Scott Henley and Janice Yen for their work on the conduct of the study. Dr Schweizer received compensation for his assistance.