Clinical trial NCT02110693: The Tobacco, Alcohol, Prescription Medication and Other Substances Tool
Official title: The TAPS Tool: Screen and Brief Assessment Tool Validation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use Disorder
Keywords: Substance Use
Substance Use Disorder
Screening
Brief Assessment
Lead sponsor: Friends Research Institute, Inc.
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Johns Hopkins University
name: Virginia Commonwealth University
name: NYU Langone Health
name: Duke University
First posted: 2014-04-10
Enrollment: 2057
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: SCREENING

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.


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

Primary outcomes:
measure: Diagnostic and Statistical Manual-5 (DSM-5) Alcohol Use Disorder Diagnosis Measured by the Modified World Mental Health Composite International Diagnostic Interview
timeFrame: Baseline
measure: Diagnostic and Statistical Manual-5 (DSM-5) Cannabis Use Disorder Diagnosis Measured With Modified World Mental Health Composite International Diagnostic Interview
timeFrame: Baseline
measure: 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
timeFrame: Baseline
measure: Diagnostic and Statistical Manual DSM-5 Diagnosis of Heroin Use Disorder Measured by the The Modified World Mental Health Composite International Diagnostic Interview
timeFrame: Baseline
measure: Diagnostic and Statistical Manual DSM-5 Diagnosis of Tobacco Use Disorder Measured by the Modified World Mental Health Composite International Diagnostic Interview
timeFrame: Baseline
Secondary outcomes:
measure: High Risk Tobacco Use Measured by the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST)
timeFrame: Baseline
measure: Unhealthy Cannabis Use
timeFrame: Baseline
measure: Risky Alcohol Use
timeFrame: Baseline
measure: Cigarette Smoking Risk
timeFrame: baseline
measure: Smokeless Tobacco Questionnaire
timeFrame: baseline
measure: Cannabis Positive Oral Fluid Test
timeFrame: baseline
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Chase Brexton Health Services
state: Maryland
city: New York
country: United States
facility: Bellevue Hospital
state: New York
city: Kannapolis
country: United States
facility: MURDOCK Study
state: North Carolina
city: Richmond
country: United States
facility: Virginia Commonwealth University Health System Ambulatory Care Center
state: Virginia
Study officials:
affiliation: Friends Research Institute, Inc.
name: Robert P Schwartz, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Li-Tzy Wu, Psy.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: New York University
name: Jennifer McNeely, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.