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Completed

NCT Number: NCT02110693

The Tobacco, Alcohol, Prescription Medication and Other Substances Tool

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chase Brexton Health Services, Baltimore, Maryland, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interviewer and tablet administration of the TAPS Tool

Other

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Friends Research Institute, Inc.

Other

Collaborators

  • Duke University
  • Johns Hopkins University
  • NYU Langone Health
  • National Institute on Drug Abuse (NIDA)
  • Virginia Commonwealth University

Registry information

Official study title

The TAPS Tool: Screen and Brief Assessment Tool Validation Study

Acronym: CTN0059

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 10, 2014
Registry last updated
Jul 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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