Submitted for Publication: May 21, 2013; final revision received July 10, 2013; accepted August 8, 2013.
Published Online: January 15, 2014. doi:10.1001/jamapsychiatry.2013.3947.
Study concept and design: Allsop, Copeland, Lintzeris, Dunlop, Sadler, Rivas, Muhleisen, Norberg, McGregor.
Acquisition of data: Allsop, Lintzeris, Montebello, Sadler, Rivas, Holland, Norberg, Booth, McGregor.
Analysis and interpretation of data: Allsop, Copeland, Lintzeris, Dunlop, Montebello, McGregor.
Drafting of the manuscript: Allsop, Copeland, Lintzeris, Dunlop, Norberg, Booth, McGregor.
Critical revision of the manuscript for important intellectual content: Allsop, Lintzeris, Dunlop, Montebello, Sadler, Rivas, Holland, Muhleisen, Norberg, McGregor.
Statistical analysis: Allsop, McGregor.
Obtained funding: Allsop, Copeland, Lintzeris, Dunlop, Norberg, McGregor.
Administrative, technical, or material support: Allsop, Copeland, Lintzeris, Montebello, Sadler, Rivas, Holland, Muhleisen, Norberg, Booth, McGregor.
Study supervision: Allsop, Copeland, Lintzeris, Dunlop, Montebello, Norberg.
Conflict of Interest Disclosures: Dr Allsop’s institution received funding for his salary from the National Health and Medical Research Council (NHMRC) and the Australian Government Department of Health and Aging, and he received funding from the National Institute on Drug Abuse to attend a conference in the United States in November 2011. No other conflicts were reported.
Funding/Support: This study was funded by project grant 1006036 from the NHMRC. Study drugs (nabiximols and placebo) were provided free of charge by GW Pharmaceuticals, UK.
Role of the Sponsor: The NHMRC and GW Pharmaceuticals, UK, had no role in the design and conduct of the study; the collection, management, analysis, or interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Additional Contributions: Deborah Zador, MD, Bas Dall, MD, Hester Wilson, MD, and Victoria Hayes, MD, medically screened study participants. Sarah Kezelman, BPsych (Hons), Lucy Albertella, MSc, Sherilyn Thomson, BPsych(Hons), and Claudia Sannibale, PhD, administered the Structured Clinical Interviews for drug dependence diagnoses (all SCID-RV interviewers were remunerated for their services). Julie Spencer, RN, MPH, Jackie O’Mahony, MSN (nurse practitioner), and the nursing staff at Ward 2 East, Sydney Hospital and Sydney Eye Hospital, and Cathy Fisk, RN, Lynne Robertson, RN AAS, and the nursing staff at Lakeview Detox Unit, Belmont Hospital, Newcastle, provided daily patient care, medication delivery, and clinical data collection. Celia Weight, BPharm, and Judith Hampson, BPharm, MHA, provided pharmaceutical services for managing medications and randomization (all pharmaceutical services were reimbursed). Ryan Vandrey, PhD, provided suggestions on the manuscript. Tim Slade, PhD, Mathew Sunderland, PhD, Raimondo Bruno, PhD, and Barbara Toson BSc(Hons) contributed statistical support and advice. The toxicology unit of Pacific Laboratory Medicine Services coordinated the urinalysis studies, and toxicology services were reimbursed. All named individuals without a financial disclosure here did not receive any reimbursement from project funds for their contributions to the study.
Correction: This article was corrected on March 14, 2014, to provide additional data in Table 1.