Design of the NIDA Clinical Trials Network Validation Study of Tobacco, Alcohol, Prescription Medications, and Substance use/misuse (TAPS) Tool

Contemp Clin Trials. 2016 Sep;50:90-7. doi: 10.1016/j.cct.2016.07.013. Epub 2016 Jul 19.

Abstract

Background: 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.

Methods: 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.

Discussion: 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.

Trial registration: ClinicalTrials.gov NCT02110693.

Keywords: Instrument; Screening; Substance use disorder; Tool; Validation.

Publication types

  • Clinical Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Alcoholism / diagnosis
  • Female
  • Humans
  • Male
  • Mass Screening / methods*
  • National Institute on Drug Abuse (U.S.)
  • Opioid-Related Disorders / diagnosis
  • Pilot Projects
  • Primary Health Care / methods*
  • Random Allocation
  • Reproducibility of Results
  • Research Design*
  • Substance-Related Disorders / diagnosis*
  • Tobacco Use Disorder / diagnosis
  • United States

Associated data

  • ClinicalTrials.gov/NCT02110693