title: Design of the NIDA clinical trials network validation study of tobacco, alcohol, prescription medications, and substance use/misuse (TAPS) tool.
abstract: Substance use and its associated use disorders are under-detected and under-treated in primary care. There is a need for a clinically useful brief screening and assessment instrument to identify primary care patients with substance use, sub-threshold substance use disorder (SUD), and SUD to facilitate brief intervention and treatment.
  
  
  
  We describe the design of the recently completed National Drug Abuse Treatment Clinical Trials Network's tobacco, alcohol, prescription medications, and substance use/misuse screen and brief assessment tool validation study. Study aims included to: develop a 2-stage screening and brief assessment tool (TAPS Tool) to detect substance use, problem use, and SUD among adult primary care patients; examine the validity of both the screen component and the TAPS Tool by comparing them to reference standard screening and assessment measures of no use, problem use, and SUD; and determine the feasibility and acceptability of the self-administration and interviewer-administration of the tool. The design included a pilot testing phase (n=30) and the main study of 2000 adult primary care participants who were randomly assigned in counter-balanced order to have the interviewer-administration or the self-administration of the TAPS Tool followed by the other administration format. Participants' views of feasibility, acceptability and preference for format of self-administration versus interviewer-administration of the TAPS Tool were assessed. Criterion measures of use and DSM-5 SUDs were administered.
  
  
  
  The TAPS Tool study builds on prior work to develop a 2-stage clinical tool for facilitating the adoption of screening, brief assessment and treatment for SUDs in primary care.
authors.affiliation: Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC, USA; Department of Medicine, Division of General Internal Medicine, Duke University Medical Center, Durham, NC, USA; Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA; Center for Child and Family Policy, Duke University, Durham, NC, USA. Electronic address: Litzy.wu@duke.edu.
authors.forename: Li-Tzy
authors.initials: LT
authors.lastname: Wu
authors.affiliation: Department of Population Health, New York University School of Medicine, New York, NY, USA.
authors.forename: Jennifer
authors.initials: J
authors.lastname: McNeely
authors.affiliation: National Institute on Drug Abuse, Bethesda, MD, USA.
authors.forename: Geetha A
authors.initials: GA
authors.lastname: Subramaniam
authors.affiliation: The EMMES Corporation, Rockville, MD, USA.
authors.forename: Gaurav
authors.initials: G
authors.lastname: Sharma
authors.affiliation: The EMMES Corporation, Rockville, MD, USA.
authors.forename: Paul
authors.initials: P
authors.lastname: VanVeldhuisen
authors.affiliation: Friends Research Institute, Inc., Baltimore, MD, USA.
authors.forename: Robert P
authors.initials: RP
authors.lastname: Schwartz
mesh_terms: D000437:Alcoholism / Q000175:diagnosis; D005260:Female; D006801:Humans; D008297:Male; D008403:Mass Screening / Q000379:methods*; D054577:National Institute on Drug Abuse (U.S.); D009293:Opioid-Related Disorders / Q000175:diagnosis; D010865:Pilot Projects; D011320:Primary Health Care / Q000379:methods*; D011897:Random Allocation; D015203:Reproducibility of Results; D012107:Research Design; D019966:Substance-Related Disorders / Q000175:diagnosis*; D014029:Tobacco Use Disorder / Q000175:diagnosis; D014481:United States
keywords: Instrument; Screening; Substance use disorder; Tool; Validation