Submitted for Publication: January 24, 2011; final revision received May 24, 2011; accepted May 25, 2011.
Published Online: November 7, 2011. doi:10.1001/archgenpsychiatry.2011.121
Financial Disclosure: Dr Weiss serves as a consultant to Titan Pharmaceuticals and reports receiving research grant support from Eli Lilly& Co. Dr Potter serves as a consultant for Observant LLC, has received research support from Forest Laboratories, has developed education presentations for the Veteran's Health Administration, and was compensated for travel for presentations at research meetings by the American Pain Society. Dr Fiellin serves as a consultant to Pinney Associates, serving on an external advisory board to monitor the abuse and diversion of buprenorphine. Dr Dickinson serves as a consultant for the American Society of Addiction Medicine Physician Clinical Support System and is a treatment advocate and speaker for Reckitt Benckiser. Dr Gourevitch receives research support from Alkermes to study extended-release naltrexone for alcohol dependence. Dr McCance-Katz reports receiving medication from Reckitt Benckiser for an unrelated study funded by NIDA and has received a lecture fee from PCM Scientific. Dr Somoza has received grant support from Catalyst Partners Pharmaceuticals and has received medication from Titan Pharmaceuticals for a research study. Dr Sonne reports receiving research support from Forest Laboratories. Dr Ling reports receiving research support from Reckitt Benckiser, Titan Pharmaceuticals, and Hythiam and speaker fees from Reckitt Benckiser and is a member of the advisory board of US WorldMeds.
Funding/Support: This study was supported by NIDA CTN grants 2U10DA015831, 2U10DA013045, 2U10DA015815, 2U10DA013727, 2U10DA020036, 2U10DA013035, 2U10DA013714, and 5U10DA013732; NIDA contracts HHSN2712005220HC and HHSN271200522081C; and NIDA grants K24 DA022288, K23 DA022297, and K24 DA023359. This study was also supported by an independent clinical coordinating center, The EMMES Corp, under contract with the NIDA CTN. The clinical coordinating center conducted site initiation, interim, and close-out quality assurance monitoring visits at the clinical sites. This study was supported by an independent data management center, the Duke Clinical Research Institute in Durham under contract with the NIDA CTN. The Duke Clinical Research Institute was responsible for oversight of data management and data entry through the study's secure, password-protected, Web-based electronic data capture system. Study medication was provided by Reckitt Benckiser to the NIDA CTN.
Role of the Sponsor: The sponsor of the study was the NIDA Center for the Clinical Trials Network (CCTN). The NIDA CCTN collaborated in the design and conduct of the study. The protocol review committee of the CTN provided guidance and final approval of the study design. An independent data safety and monitoring board, appointed by the NIDA CCTN, conducted periodic reviews of study safety data. The publications committee of the CTN gave final approval of the analysis and interpretation of the data and approved the manuscript.
Additional Contributions: The participating sites were Chestnut Ridge Hospital, San Francisco General Hospital, St. Luke's Roosevelt Hospital, Long Island Jewish Medical Center–Addiction Recovery Services, Bellevue Hospital Center, McLean Hospital, East Indiana Treatment Center, Adapt Inc, UCLA Integrated Substance Abuse Programs, Behavioral Health Service of Pickens County, and Providence Behavioral Health Services.