Submitted for Publication: September 13, 2012; final revision received March 26, 2013; accepted March 28, 2013.
Published Online: October 23, 2013. doi:10.1001/jamapsychiatry.2013.2216.
Study concept and design: Sigmon, Heil, Higgins.
Acquisition of data: Sigmon, Dunn, Saulsgiver, Patrick, Brooklyn.
Analysis and interpretation of data: Sigmon, Dunn, Saulsgiver, Patrick, Badger, Heil.
Drafting of the manuscript: Sigmon, Dunn, Saulsgiver, Patrick, Heil, Brooklyn, Higgins.
Critical revision of the manuscript for important intellectual content: Sigmon, Dunn, Saulsgiver, Badger, Higgins.
Statistical analysis: Sigmon, Badger.
Obtained funding: Sigmon, Heil, Higgins.
Administrative, technical, and material support: Sigmon, Saulsgiver, Patrick, Brooklyn.
Study supervision: Sigmon, Dunn.
Conflict of Interest Disclosures: In recent years, Dr Sigmon has received consulting payments from Alkermes and, through her university, has received research support from Titan Pharmaceuticals. In the past, Dr Brooklyn was a paid mentor in the Physician Clinical Support System for training physicians in buprenorphine use. No other disclosures were reported.
Funding/Support: This study was supported by research grant R01-DA019989 (Dr Sigmon) and training grant T32 DA007242 (Dr Higgins) from the National Institute on Drug Abuse. Buprenorphine/naloxone and color-matched placebo sublingual tablets were provided by Reckitt Benckiser Pharmaceuticals Inc through the National Institute on Drug Abuse.
Role of the Sponsor: The National Institute on Drug Abuse and Reckitt Benckiser Pharmaceuticals Inc had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Additional Contributions: Betsy Bahrenburg, RN, Bruce Brown, BS, LICSW, LADC, and other research staff assisted in conducting this study. Leigh Ann Holterman, BS, provided statistical support. As paid staff members, these individuals received salary support but no additional financial compensation from the authors.