Study concept and design: Evins, Cather, Goff, Schoenfeld.
Acquisition of data: Evins, Cather, Pratt, Pachas, Achtyes, Ayer.
Analysis and interpretation of data: Evins, Cather, Pachas, Hoeppner, Goff, Ayer, Schoenfeld.
Drafting of the manuscript: Evins, Cather, Schoenfeld.
Critical revision of the manuscript for important intellectual content: Evins, Cather, Pratt, Pachas, Hoeppner, Goff, Achtyes, Ayer, Schoenfeld.
Statistical analysis: Hoeppner, Schoenfeld.
Obtained funding: Evins.
Administrative, technical, or material support: Evins, Cather, Pratt, Pachas, Achtyes, Ayer.
Study supervision: Evins, Cather, Pratt, Pachas, Achtyes, Ayer.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Evins reports receiving product and financial support to her institution from EnVivo Pharmaceuticals for a NIDA funded trial of an alpha-7 nicotinic agonist for smoking cessation in non-psychiatrically ill smokers and from GSK to conduct Phase II trials of novel compounds for a NIDA funded Cooperative Drug Discovery Group for Nicotine Dependence and consulting for the Pfizer advisory board. Dr Cather reports consulting to Prophase. Dr Goff reports receiving financial support from Pfizer as the principal investigator of an investigator-initiated trial of high-dose ziprasidone to treat schizophrenia. Dr Achtyes reports consulting for Publicis Healthcare Communications Group to complete a survey and receiving salary paid to him by his full-time employer, Pine Rest Christian Mental Health Services, financial support to his institution from Cherry Street Health Services, where he is a consulting psychiatrist, and financial support to his institution from Michigan State University. Dr Achtyes reports that the following grants to his institution are pending from Janssen, Otsuka, North Shore Long Island Jewish Health System, Dartmouth College, Pine Rest Foundation, University of Chicago, AssurEx, and Eli Lilly. Dr Shoenfeld reports receiving financial support from the National Institutes of Health and receiving compensation for consultation to Pfizer Inc. No other disclosures were reported.
Funding/Support: This study was funded by grants R01 DA021245 by National Institute on Drug Abuse with supplemental financial and material support from an investigator-initiated award from Pfizer for study medications and funding, and by 05B1MACMHS to the Massachusetts Department of Mental Health from the Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, Treatment Strategies for Smoking Cessation in Patients with Schizophrenia to the North Suffolk Mental Health Association (Dr Evins). Pfizer provided study medication and supplemental support through an investigator-initiated award after the protocol was approved by the institutional review board and the data and safety monitoring board.
Role of the Sponsor: The external funders had no role in design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, or approval of the manuscript; and decision to submit the manuscript for publication. At the time of submission and solely as a courtesy, a copy of the manuscript was given to Pfizer, which offered neither edits nor approval to publish.
Disclaimer: Dr Goff, an associate editor of JAMA, was not involved in the evaluation or decision to publish this article.
Additional Contributions: We thank the following contributors, who received no compensation: Nancy Rigotti, MD (Massachusetts General Hospital and Harvard Medical School), Harry Lando, PhD (University of Minnesota), and Kim Mueser, PhD (Dartmouth Medical School and Boston University) for their thoughtful input at various stages of the project on study planning and design and protocol implementation; Anne Thorndike, MD (Massachusetts General Hospital and Harvard Medical School), chair of the data and safety monitoring board for her thoughtful and helpful input, and Ivan Montoya, MD, MPH (National Institute on Drug Abuse) for his unflagging support for this project. We also thank Johanna Nino, MD (Massachusetts General Hospital), who led the training and monitoring at all study sites for the first 2 years of the study and Erika Weisz, BS (Massachusetts General Hospital), who led the training and monitoring at all study sites and led the data collection at the Massachusetts General Hospital for the latter 2 years of the study; Sarah Carlini, BA (Massachusetts General Hospital), Megan Santos, LICSW (Dartmouth Medical School), and Heather Mayle, MA (Cherry Street Health Services) who led the data collection and monitoring at their respective institutions; and Max Curran, BA (Massachusetts General Hospital), who created all the graphical displays of the data.