Substance Use DisorderCTN0059NCT02110693

The Tobacco, Alcohol, Prescription Medication and Other Substances Tool

A study testing Interviewer and tablet administration of the TAPS Tool in people with Substance Use Disorder, run by Friends Research Institute, Inc. at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Substance Use Disorder
What is being tested?: Interviewer and tablet administration of the TAPS Tool
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,057 participants
Where: 4 sitesUnited States
Study dates: Mar 2014to Apr 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Primary care patients
Able to provide informed consent

Who cannot join

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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Chase Brexton Health Services
Baltimore, Maryland, 21201
MURDOCK Study
Kannapolis, North Carolina, 28081
Bellevue Hospital
New York, New York, 10016
Virginia Commonwealth University Health System Ambulatory Care Center
Richmond, Virginia, 23284

Other trials in United States

About this study

Official title: The TAPS Tool: Screen and Brief Assessment Tool Validation Study

Conditions: Substance Use Disorder
Being tested: Interviewer and tablet administration of the TAPS Tool
Keywords: Substance Use, Substance Use Disorder, Screening, Brief Assessment
Medical subject headings: Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT02110693
Study group	Role	What they receive
Interviewer and tablet administration	Other	All participants were administered the TAPS Tool via interviewer and tablet computer self-administration in the same session. Receives: Other: Interviewer and tablet administration of the TAPS Tool

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline

Secondary outcomes (6)

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).
Measured: Baseline
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
Measured: Baseline
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).
Measured: Baseline
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.
Measured: baseline
Smokeless Tobacco Questionnaire
Any yes response to smokeless tobacco use reported on the smokeless tobacco questionnaire is considered high risk.
Measured: baseline
Cannabis Positive Oral Fluid Test
Positive Oral Fluid Cannabis testing.
Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2014Apr 2015

First posted10 Apr 2014 (estimated)
Study startMar 2014
Primary completionApr 2015
Study completionApr 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Substance Use DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Screening
Allocation: Not applicable
Intervention model: Single group
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)
Enrolment: 2,057 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02110693
Sponsor's protocol ID: CTN 0059
Other IDs: 2U10DA013034
Acronym: CTN0059
Status last verified: Jun 2018
First submitted: 2 Apr 2014
Last updated: 26 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 27595276
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.
PubMed 27444426

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The TAPS Tool: Screen and Brief Assessment Tool Validation Study
ClinicalTrials.gov ID: NCT02110693
Acronym / sponsor ID: CTN0059 / CTN 0059
Conditions: Substance Use Disorder
Keywords: Substance Use, Substance Use Disorder, Screening, Brief Assessment
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,057 participants (actual)
Lead sponsor: Friends Research Institute, Inc.University, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA), Johns Hopkins University, Virginia Commonwealth University, NYU Langone Health, Duke University
Study start: Mar 2014
Primary completion: Apr 2015 (actual)
Study completion: Apr 2015 (actual)
First posted: 10 Apr 2014 (estimated)
Results: Posted 17 Apr 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Screening
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
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.

Arm	Type	Receives
Interviewer and tablet administration	Other	Other: Interviewer and tablet administration of the TAPS ToolAll participants were administered the TAPS Tool via interviewer and tablet computer self-administration in the same session.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Primary care patients
Able to provide informed consent

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Interviewer and tablet administration of the TAPS ToolAll participant will self-administer substance use screening instrument (TAPS Tool) on a tablet computer and will be administered the TAPS Tool by an interviewer.	Other	Interviewer and tablet administration

Primary outcome

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
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
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
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
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

6 secondary outcomes

High Risk Tobacco Use Measured by the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST)
Time frame: Baseline
Unhealthy Cannabis Use
Time frame: Baseline
Risky Alcohol Use
Time frame: Baseline
Cigarette Smoking Risk
Time frame: baseline
Smokeless Tobacco Questionnaire
Time frame: baseline
Cannabis Positive Oral Fluid Test
Time frame: baseline

Results and safety

Results posted to the registry on 17 Apr 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Interviewer Then Tablet Administration	1,026	998
Tablet First Then Interviewer Administration	1,031	1,002

Primary outcome: 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. Number (95% Confidence Interval). Unit: Sensitivity

Measure	Interviewer Administration n = 2000	Tablet Administration n = 2000
Value	.70 (.64 to .75)	.74 (.68 to .79)

Interviewer Administration: Sensitivity: .70 (95% CI .64 to .75)
Tablet Administration: Sensitivity: .74 (95% CI .68 to .79)

Population analysed: Adult primary care patients

Primary outcome: Diagnostic and Statistical Manual-5 (DSM-5) Cannabis Use Disorder Diagnosis Measured With Modified World Mental Health Composite International Diagnostic Interview

Time frame: Baseline. Number (95% Confidence Interval). Unit: Sensitivity

Measure	Interviewer Administration n = 2000	Tablet Administration n = 2000
Value	0.71 (.63 to .79)	.70 (.62 to .77)

Interviewer Administration: Sensitivity: .71 (95% CI .63 to .79)
Tablet Administration: Sensitivity: .70 (95% CI .62 to .77)

Population analysed: Adult primary care population

Primary outcome: 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. Number (95% Confidence Interval). Unit: Sensitivity

Measure	Interviewer Administration n = 2000	Tablet Administration n = 2000
Value	.57 (.47 to .67)	.60 (.50 to .69)

Interviewer Administration: Sensitivity: .57 (95% CI .47 to .67)
Tablet Administration: Sensitivity: .60 (95% CI .50 to .69)

Population analysed: Adult primary care patients

Primary outcome: 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. Number (95% Confidence Interval). Unit: Sensitivity

Measure	Interviewer Administration n = 2000	Tablet Administration n = 2000
Value	.66 (.53 to .77)	.66 (.53 to .77)

Interviewer Administration: sensivity: .66 (95% CI .53 to .77)
Tablet Administration: Sensivity: .66 (95% CI .53 to .77)

Population analysed: Adult primary care patients

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline data only gathered in this study.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Participants	0 of 2,000 (0%)	16 of 2,000 (0.8%)	0 of 2,000

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27595276McNeely 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.
Derived from this study: PubMed 27444426Wu 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Robert P Schwartz, M.D. principal investigator

Friends Research Institute, Inc.

Li-Tzy Wu, Psy.D. principal investigator

Duke University

Jennifer McNeely, M.D. principal investigator

New York University

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Interviewer and tablet administration of the TAPS Tool in people with Substance Use Disorder, run by Friends Research Institute, Inc. at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02110693, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2018.