The Tobacco, Alcohol, Prescription Medication and Other Substances Tool

Not Applicable

Completed

• Conditions: Substance Use Disorder
• Interventions: Other: Interviewer and tablet administration of the TAPS Tool

• Registration Number: NCT02110693
• Lead Sponsor: Friends Research Institute, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-04-02
• Study First Submitted QC: 2014-04-08
• Study First Posted: 2014-04-10
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Results First Submitted: 2016-10-25
• Results First Submitted QC: 2018-03-15
• Results First Posted: 2018-04-17
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-29
• Last Update Posted: 2018-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2057

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Interviewer and tablet administration	Interviewer and tablet administration of the TAPS Tool	All participants were administered the TAPS Tool via interviewer and tablet computer self-administration in the same session.

Primary Outcome Measures

Name	Time	Method
Diagnostic and Statistical Manual-5 (DSM-5) Alcohol Use Disorder Diagnosis Measured by the Modified World Mental Health Composite International Diagnostic Interview	Baseline	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	Baseline	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	Baseline	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	Baseline	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	Baseline	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

Name	Time	Method
High Risk Tobacco Use Measured by the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST)	Baseline	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).
Risky Alcohol Use	Baseline	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	baseline	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	baseline	Any yes response to smokeless tobacco use reported on the smokeless tobacco questionnaire is considered high risk.
Unhealthy Cannabis Use	Baseline	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
Cannabis Positive Oral Fluid Test	baseline	Positive Oral Fluid Cannabis testing.

Trial Locations

Locations (4)

Chase Brexton Health Services; 🇺🇸 Baltimore, Maryland, United States

Bellevue Hospital; 🇺🇸 New York, New York, United States

MURDOCK Study; 🇺🇸 Kannapolis, North Carolina, United States

Virginia Commonwealth University Health System Ambulatory Care Center; 🇺🇸 Richmond, Virginia, United States