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The Tobacco, Alcohol, Prescription Medication and Other Substances Tool (CTN0059)

Primary Purpose

Substance Use Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Interviewer and tablet administration of the TAPS Tool
Sponsored by
Friends Research Institute, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Substance Use Disorder focused on measuring Substance Use, Substance Use Disorder, Screening, Brief Assessment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Primary care patients
  • Able to provide informed consent

Exclusion Criteria:

  • inability to comprehend spoken English
  • inability to self-administer the instrument on the tablet computer due to physical limitations
  • previously enrolled in the study

Sites / Locations

  • Chase Brexton Health Services
  • Bellevue Hospital
  • MURDOCK Study
  • Virginia Commonwealth University Health System Ambulatory Care Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Interviewer and tablet administration

Arm Description

All participants were administered the TAPS Tool via interviewer and tablet computer self-administration in the same session.

Outcomes

Primary Outcome Measures

Diagnostic and Statistical Manual-5 (DSM-5) Alcohol Use Disorder Diagnosis Measured by the Modified World Mental Health Composite International Diagnostic Interview
The Modified World Mental Health Composite International Diagnostic Interview is a structured interview that assesses whether or not the participant meets DSM-5 Diagnostic Criteria
Diagnostic and Statistical Manual-5 (DSM-5) Cannabis Use Disorder Diagnosis Measured With Modified World Mental Health Composite International Diagnostic Interview
The Modified World Mental Health Composite International Diagnostic Interview is a structured interview that assesses whether or not the participant meets DSM-5 Diagnostic Criteria
Diagnostic and Statistical Manual-5 (DSM-5) Cocaine and Amphetamine (Stimulant) Use Disorder Diagnosis Measured by the Modified World Mental Health Composite International Diagnostic Interview
The Modified World Mental Health Composite International Diagnostic Interview is a structured interview that assesses whether or not the participant meets DSM-5 Diagnostic Criteria
Diagnostic and Statistical Manual DSM-5 Diagnosis of Heroin Use Disorder Measured by the The Modified World Mental Health Composite International Diagnostic Interview
The Modified World Mental Health Composite International Diagnostic Interview is a structured interview that assesses whether or not the participant meets DSM-5 Diagnostic Criteria
Diagnostic and Statistical Manual DSM-5 Diagnosis of Tobacco Use Disorder Measured by the Modified World Mental Health Composite International Diagnostic Interview
The Modified World Mental Health Composite International Diagnostic Interview is a structured interview that assesses whether or not the participant meets DSM-5 Diagnostic Criteria

Secondary Outcome Measures

High Risk Tobacco Use Measured by the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST)
The ASSIST assess lifetime and past 3 month substance use. A score on the Tobacco Scale from 0-3 is low risk, 4-26 is medium risk, and 27 or greater is high risk.The scales range is from 0 (no problem) to 31 (most severe problem).
Unhealthy Cannabis Use
The Time Line Follow Back Interview measures participant's self-reported number of days of cannabis use in the 30 days prior to the interview. Unhealthy cannabis use is considered 1 or more days of cannabis use in the past 30 days.The reported data represent the correlation between the TAPS Tool Cannabis Score and the Number of Days of cannabis use
Risky Alcohol Use
Measured by the Alcohol Use Disorders Identification Test - Consumption Items. High risk on the AUDIT-C is 10 or higher. The higher the score on the AUDIT-C the greater the alcohol problem.The range of scores on the AUDIT-C is from 0 (no problem) to 12 (maximum problem).
Cigarette Smoking Risk
Measured by the Fagerstrom Test for Nicotine Dependence. The range of scores on the Fagerstrom Test if from 0 (no risk) to 10 (highest risk). High risk is considered a score of 6 or greater.
Smokeless Tobacco Questionnaire
Any yes response to smokeless tobacco use reported on the smokeless tobacco questionnaire is considered high risk.
Cannabis Positive Oral Fluid Test
Positive Oral Fluid Cannabis testing.

Full Information

First Posted
April 2, 2014
Last Updated
June 29, 2018
Sponsor
Friends Research Institute, Inc.
Collaborators
National Institute on Drug Abuse (NIDA), Johns Hopkins University, Virginia Commonwealth University, NYU Langone Health, Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT02110693
Brief Title
The Tobacco, Alcohol, Prescription Medication and Other Substances Tool
Acronym
CTN0059
Official Title
The TAPS Tool: Screen and Brief Assessment Tool Validation Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Friends Research Institute, Inc.
Collaborators
National Institute on Drug Abuse (NIDA), Johns Hopkins University, Virginia Commonwealth University, NYU Langone Health, Duke University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to develop and validate a questionnaire to screen and assess adult primary care patients for tobacco, alcohol, prescription drug, and drug use and problems related to their use.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorder
Keywords
Substance Use, Substance Use Disorder, Screening, Brief Assessment

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This study examined the accuracy of a substance abuse screening test compared to gold standard measures Participants all received the experimental screening instrument (via self- and tablet computer administration. The order of administration was randomly selected in order to control for an order effect.
Masking
None (Open Label)
Allocation
N/A
Enrollment
2057 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interviewer and tablet administration
Arm Type
Other
Arm Description
All participants were administered the TAPS Tool via interviewer and tablet computer self-administration in the same session.
Intervention Type
Other
Intervention Name(s)
Interviewer and tablet administration of the TAPS Tool
Intervention Description
All participant will self-administer substance use screening instrument (TAPS Tool) on a tablet computer and will be administered the TAPS Tool by an interviewer.
Primary Outcome Measure Information:
Title
Diagnostic and Statistical Manual-5 (DSM-5) Alcohol Use Disorder Diagnosis Measured by the Modified World Mental Health Composite International Diagnostic Interview
Description
The Modified World Mental Health Composite International Diagnostic Interview is a structured interview that assesses whether or not the participant meets DSM-5 Diagnostic Criteria
Time Frame
Baseline
Title
Diagnostic and Statistical Manual-5 (DSM-5) Cannabis Use Disorder Diagnosis Measured With Modified World Mental Health Composite International Diagnostic Interview
Description
The Modified World Mental Health Composite International Diagnostic Interview is a structured interview that assesses whether or not the participant meets DSM-5 Diagnostic Criteria
Time Frame
Baseline
Title
Diagnostic and Statistical Manual-5 (DSM-5) Cocaine and Amphetamine (Stimulant) Use Disorder Diagnosis Measured by the Modified World Mental Health Composite International Diagnostic Interview
Description
The Modified World Mental Health Composite International Diagnostic Interview is a structured interview that assesses whether or not the participant meets DSM-5 Diagnostic Criteria
Time Frame
Baseline
Title
Diagnostic and Statistical Manual DSM-5 Diagnosis of Heroin Use Disorder Measured by the The Modified World Mental Health Composite International Diagnostic Interview
Description
The Modified World Mental Health Composite International Diagnostic Interview is a structured interview that assesses whether or not the participant meets DSM-5 Diagnostic Criteria
Time Frame
Baseline
Title
Diagnostic and Statistical Manual DSM-5 Diagnosis of Tobacco Use Disorder Measured by the Modified World Mental Health Composite International Diagnostic Interview
Description
The Modified World Mental Health Composite International Diagnostic Interview is a structured interview that assesses whether or not the participant meets DSM-5 Diagnostic Criteria
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
High Risk Tobacco Use Measured by the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST)
Description
The ASSIST assess lifetime and past 3 month substance use. A score on the Tobacco Scale from 0-3 is low risk, 4-26 is medium risk, and 27 or greater is high risk.The scales range is from 0 (no problem) to 31 (most severe problem).
Time Frame
Baseline
Title
Unhealthy Cannabis Use
Description
The Time Line Follow Back Interview measures participant's self-reported number of days of cannabis use in the 30 days prior to the interview. Unhealthy cannabis use is considered 1 or more days of cannabis use in the past 30 days.The reported data represent the correlation between the TAPS Tool Cannabis Score and the Number of Days of cannabis use
Time Frame
Baseline
Title
Risky Alcohol Use
Description
Measured by the Alcohol Use Disorders Identification Test - Consumption Items. High risk on the AUDIT-C is 10 or higher. The higher the score on the AUDIT-C the greater the alcohol problem.The range of scores on the AUDIT-C is from 0 (no problem) to 12 (maximum problem).
Time Frame
Baseline
Title
Cigarette Smoking Risk
Description
Measured by the Fagerstrom Test for Nicotine Dependence. The range of scores on the Fagerstrom Test if from 0 (no risk) to 10 (highest risk). High risk is considered a score of 6 or greater.
Time Frame
baseline
Title
Smokeless Tobacco Questionnaire
Description
Any yes response to smokeless tobacco use reported on the smokeless tobacco questionnaire is considered high risk.
Time Frame
baseline
Title
Cannabis Positive Oral Fluid Test
Description
Positive Oral Fluid Cannabis testing.
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Primary care patients Able to provide informed consent Exclusion Criteria: inability to comprehend spoken English inability to self-administer the instrument on the tablet computer due to physical limitations previously enrolled in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert P Schwartz, M.D.
Organizational Affiliation
Friends Research Institute, Inc.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Li-Tzy Wu, Psy.D.
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jennifer McNeely, M.D.
Organizational Affiliation
New York University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chase Brexton Health Services
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Bellevue Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
MURDOCK Study
City
Kannapolis
State/Province
North Carolina
ZIP/Postal Code
28081
Country
United States
Facility Name
Virginia Commonwealth University Health System Ambulatory Care Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23284
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27595276
Citation
McNeely J, Wu LT, Subramaniam G, Sharma G, Cathers LA, Svikis D, Sleiter L, Russell L, Nordeck C, Sharma A, O'Grady KE, Bouk LB, Cushing C, King J, Wahle A, Schwartz RP. Performance of the Tobacco, Alcohol, Prescription Medication, and Other Substance Use (TAPS) Tool for Substance Use Screening in Primary Care Patients. Ann Intern Med. 2016 Nov 15;165(10):690-699. doi: 10.7326/M16-0317. Epub 2016 Sep 6.
Results Reference
derived
PubMed Identifier
27444426
Citation
Wu LT, McNeely J, Subramaniam GA, Sharma G, VanVeldhuisen P, Schwartz RP. 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. Erratum In: Contemp Clin Trials. 2016 Nov;51:98.
Results Reference
derived

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