• Contemp Clin Trials · Sep 2016

    Clinical Trial

    Design of the NIDA clinical trials network validation study of tobacco, alcohol, prescription medications, and substance use/misuse (TAPS) tool.

    • Li-Tzy Wu, Jennifer McNeely, Geetha A Subramaniam, Gaurav Sharma, Paul VanVeldhuisen, and Robert P Schwartz.
    • 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.
    • Contemp Clin Trials. 2016 Sep 1; 50: 90-7.

    BackgroundSubstance 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.MethodsWe 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.DiscussionThe 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.Copyright © 2016 Elsevier Inc. All rights reserved.

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