NCT02110693

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,057

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 2, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 10, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
3 years until next milestone

Results Posted

Study results publicly available

April 17, 2018

Completed
Last Updated

July 26, 2018

Status Verified

June 1, 2018

Enrollment Period

1.1 years

First QC Date

April 2, 2014

Results QC Date

October 25, 2016

Last Update Submit

June 29, 2018

Conditions

Substance Use Disorder

Keywords

Substance UseSubstance Use DisorderScreeningBrief Assessment

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (6)

  • High Risk Tobacco Use Measured by the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST)

    Baseline

  • Unhealthy Cannabis Use

    Baseline

  • Risky Alcohol Use

    Baseline

  • Cigarette Smoking Risk

    baseline

  • Smokeless Tobacco Questionnaire

    baseline

  • +1 more secondary outcomes

Study Arms (1)

Interviewer and tablet administration

OTHER

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

Interventions

Interviewer and tablet administration of the TAPS ToolOTHER

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.

Interviewer and tablet administration

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary care patients
  • Able to provide informed consent

You may not qualify if:

  • inability to comprehend spoken English
  • inability to self-administer the instrument on the tablet computer due to physical limitations
  • previously enrolled in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Chase Brexton Health Services

Baltimore, Maryland, 21201, United States

Location

Bellevue Hospital

New York, New York, 10016, United States

Location

MURDOCK Study

Kannapolis, North Carolina, 28081, United States

Location

Virginia Commonwealth University Health System Ambulatory Care Center

Richmond, Virginia, 23284, United States

Location

Related Publications (2)

  • 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.

    PMID: 27595276DERIVED

  • 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.

    PMID: 27444426DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Results Point of Contact

Title
Robert Schwartz
Organization
Friends Research Institute
rschwartz@friendsresearch.org
410-837-3977

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2014

First Posted

April 10, 2014

Study Start

March 1, 2014

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

July 26, 2018

Results First Posted

April 17, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

US(4)