The Tobacco, Alcohol, Prescription Medication and Other Substances Tool

Substance Use Disorder Clinical Trial

— CTN0059  

Official title:

The TAPS Tool: Screen and Brief Assessment Tool Validation Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02110693
• Other study ID #: CTN 0059
• Secondary ID: 2U10DA013034
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: April 2015

Study information

• Verified date: June 2018
• Source: Friends Research Institute, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2057
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Substance Use Disorder
• Substance-Related Disorders

Intervention

Other:
• Interviewer and tablet administration of the TAPS Tool
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.

Locations

Country	Name	City	State
United States	Chase Brexton Health Services	Baltimore	Maryland
United States	MURDOCK Study	Kannapolis	North Carolina
United States	Bellevue Hospital	New York	New York
United States	Virginia Commonwealth University Health System Ambulatory Care Center	Richmond	Virginia

Sponsors (6)

Lead Sponsor	Collaborator
Friends Research Institute, Inc.	Duke University, Johns Hopkins University, National Institute on Drug Abuse (NIDA), New York University School of Medicine, Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline
Primary	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	Baseline
Primary	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	Baseline
Primary	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	Baseline
Primary	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	Baseline
Secondary	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).	Baseline
Secondary	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	Baseline
Secondary	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).	Baseline
Secondary	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.	baseline
Secondary	Smokeless Tobacco Questionnaire	Any yes response to smokeless tobacco use reported on the smokeless tobacco questionnaire is considered high risk.	baseline
Secondary	Cannabis Positive Oral Fluid Test	Positive Oral Fluid Cannabis testing.	baseline