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

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ClinicalTrials.gov Identifier: NCT02110693
Recruitment Status : Completed
First Posted : April 10, 2014
Results First Posted : April 17, 2018
Last Update Posted : July 26, 2018
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
Johns Hopkins University
Virginia Commonwealth University
NYU Langone Health
Duke University
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Substance Use Disorder Other: Interviewer and tablet administration of the TAPS Tool Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2057 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: The TAPS Tool: Screen and Brief Assessment Tool Validation Study
Study Start Date : March 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Arm Intervention/treatment
Interviewer and tablet administration
All participants were administered the TAPS Tool via interviewer and tablet computer self-administration in the same session.
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.




Primary Outcome Measures :
  1. Diagnostic and Statistical Manual-5 (DSM-5) Alcohol Use Disorder Diagnosis Measured by the Modified World Mental Health Composite International Diagnostic Interview [ Time Frame: 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

  2. Diagnostic and Statistical Manual-5 (DSM-5) Cannabis Use Disorder Diagnosis Measured With Modified World Mental Health Composite International Diagnostic Interview [ Time Frame: 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

  3. 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 [ Time Frame: 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

  4. Diagnostic and Statistical Manual DSM-5 Diagnosis of Heroin Use Disorder Measured by the The Modified World Mental Health Composite International Diagnostic Interview [ Time Frame: 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

  5. Diagnostic and Statistical Manual DSM-5 Diagnosis of Tobacco Use Disorder Measured by the Modified World Mental Health Composite International Diagnostic Interview [ Time Frame: 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 :
  1. High Risk Tobacco Use Measured by the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) [ Time Frame: 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).

  2. Unhealthy Cannabis Use [ Time Frame: 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

  3. Risky Alcohol Use [ Time Frame: 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).

  4. Cigarette Smoking Risk [ Time Frame: 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.

  5. Smokeless Tobacco Questionnaire [ Time Frame: baseline ]
    Any yes response to smokeless tobacco use reported on the smokeless tobacco questionnaire is considered high risk.

  6. Cannabis Positive Oral Fluid Test [ Time Frame: baseline ]
    Positive Oral Fluid Cannabis testing.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02110693


Locations
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United States, Maryland
Chase Brexton Health Services
Baltimore, Maryland, United States, 21201
United States, New York
Bellevue Hospital
New York, New York, United States, 10016
United States, North Carolina
MURDOCK Study
Kannapolis, North Carolina, United States, 28081
United States, Virginia
Virginia Commonwealth University Health System Ambulatory Care Center
Richmond, Virginia, United States, 23284
Sponsors and Collaborators
Friends Research Institute, Inc.
National Institute on Drug Abuse (NIDA)
Johns Hopkins University
Virginia Commonwealth University
NYU Langone Health
Duke University
Investigators
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Principal Investigator: Robert P Schwartz, M.D. Friends Research Institute, Inc.
Principal Investigator: Li-Tzy Wu, Psy.D. Duke University
Principal Investigator: Jennifer McNeely, M.D. New York University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Friends Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT02110693    
Other Study ID Numbers: CTN 0059
2U10DA013034 ( U.S. NIH Grant/Contract )
First Posted: April 10, 2014    Key Record Dates
Results First Posted: April 17, 2018
Last Update Posted: July 26, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Friends Research Institute, Inc.:
Substance Use
Substance Use Disorder
Screening
Brief Assessment
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders