Tobacco UseTAPS-ESPNCT05476588
Tobacco, Alcohol, Prescription Drug, and Illicit Substance Use- Electronic Spanish Platform
A study testing Screening in people with Tobacco Use and Alcohol Abuse, run by Baylor Research Institute at 1 site in United States.
Trial summary
The goal of this study is to validate the TAPS-ESP as a screen and assessment that can be used in primary care for the screening and treatment of substance use. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use, Alcohol Abuse, Prescription Drug Abuse
- What is being tested?
- Screening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2022to 14 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Age 18 or older
- Current patient of the clinic
- Spanish-language preferred
- Ability to read Spanish
Who cannot join
- Unable to provide informed consent
- Inability to comprehend or read Spanish
- Inability to self-administer the iPad tool due to physical limitations
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor Scott and White Community Care
Dallas, Texas, 75246
About this study
The goal of this study is to validate the TAPS-ESP as a screen and assessment that can be used in primary care for the screening and treatment of substance use.
Read the detailed description
This Phase II study seeks to conduct further research to validate the TAPS-ESP as a Spanish language version of the screening and brief assessment and pave the way for its broad dissemination in the healthcare system. The investigators will use a novel application of a Type 1 hybrid effectiveness-implementation design, adapted to a screening validation study. The investigators will conduct a large-scale study to validate the TAPS-ESP against established diagnostic and biomarker metrics, replicating the design of the seminal English-language TAPS study.
- Conditions
- Tobacco Use, Alcohol Abuse, Prescription Drug Abuse, Substance Use
- Being tested
- Screening
- Medical subject headings
- Tobacco Use, Alcoholism, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ScreeningOther
Screening and validation of assessment tool translated into Spanish
| Study group | Role | What they receive |
|---|---|---|
| Self-Administration followed by Interviewer-Administered | Active comparator | Screening and validation of assessment tool translated into Spanish Receives: Other: Screening |
| Interviewer-Administered followed by Self-Administration | Active comparator | Screening and validation of assessment tool translated into Spanish Receives: Other: Screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tobacco, Alcohol, Prescription drug, and illicit Substance Use Tool-Electronic Spanish Platform (TAPS-ESP) primary criterion validation against the modified World Mental Health Composite International Diagnostic Interview (CIDI) in Spanish
TAPS-ESP is a two-stage screening and assessment tool that first screens for 4 broad substance abuse categories (tobacco, alcohol, prescription drug misuse, and illicit substances), then branches to the assessment for specific risks related to an array of substances. TAPS-ESP scores will be validated against the modified World Mental Health Composite International Diagnostic Interview (CIDI) including alcohol, tobacco, and 9 substance categories. The CIDI items mapped to the diagnostic criteria for each substance will serve as the primary criterion standard for validation of the TAPS-ESP. For detecting CIDI-derived substance use disorder (SUD) diagnosis, we will examine TAPS-ESP cut-points for the 4-item screener and the assessment in detecting problem severity defined by CIDI for detecting different tiers of substance use: Problem use (1+ criteria), SUD (2+ criteria), and moderate-to-severe SUD (4-11 criteria). Detection of SUD will be the primary outcome for each substance category.
Measured: 1 year
Secondary outcomes (5)
Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) for concurrent and convergent validity of the TAPS Tool
The ASSIST was developed for the World Health Organization to screen for alcohol, tobacco, and drug use in medical care settings. For each substance, the use dimensions include lifetime use, past 3 month use, urges or cravings to use, and adverse consequences from use, as well as concerns expressed by family or friends about use (lifetime, past 3 months), failed attempts to control, cut down, or stop use (lifetime, past 3 months), and drug injection (lifetime, past 3 months). The ASSIST provides substance-specific risk scores 9 substance classes, with scores of 1-3 corresponding to low risk, 4-26 (10-26 for alcohol) to moderate risk, and 27 or higher to high risk.
Measured: 1 year
Drug Abuse Screening Test (DAST-10) for concurrent and convergent validity of the TAPS Tool
The DAST-10 is a ten-item yes/no screen for general drug use problems (not including alcohol). Each item is worth one point, and respondents are tiered into risk categories based on score, with more intensive assessment recommended at a score of 6 or higher. It has been widely used in the substance use field, but does not distinguish between types of drugs used. A Spanish language version has been developed.
Measured: 1 year
CAGE (Cut Down, Annoyed, Guilty, Eye-Opener) for concurrent and convergent validity of the TAPS
The CAGE is a rapid alcoholism screening test comprised of four yes/no questions (Cut Down, Annoyed, Guilty, Eye-Opener) for which ONE yes answer to any of the four items indicates DSM-IV alcohol abuse or dependence. A Spanish language version was validated in both Spain and the US, where it performed well in identifying DSM-IV alcohol abuse or dependence among Latinx primary care patients.
Measured: 1 year
Alcohol Use Disorders Identification Test (AUDIT) for concurrent and convergent validity of the TAPS
The AUDIT is a 10-item questionnaire which covers the domains of alcohol consumption, drinking behavior, and alcohol-related problems. It was developed from a six-country World Health Organization collaborative project as a screening instrument for hazardous and harmful alcohol consumption. Responses to each of the 10 questions are scored according to a frequency rating of 0 (never) to 4 (daily), giving the entire questionnaire a possible score of 40. A score of 8 or more indicates harmful or hazardous alcohol use. A Spanish language version of the AUDIT is available.
Measured: 1 year
Fagerstrom Test for Nicotine Dependence (FTND) for concurrent and convergent validity of the TAPS
The FTND is comprised of six questions scored on a point system, with total scoring summing between 0 and 10. Higher scores indicate heavier reliance on nicotine. The FTDN has been widely used in the tobacco field for decades. It has been found to be internally consistent and an acceptable way to measure nicotine/tobacco dependency. The FTND has been translated into Spanish and validated.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study start15 Jul 2022
- Primary completion14 Mar 2024
- Study completion14 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco UseStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, two-group design.
- Masking
- None (open label)
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- COG Analytics
- Responsible party
- Sponsor
- Investigators
- Katherine Sanchez, PhD, Principal investigator, Baylor Scott & White The Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05476588
- Sponsor's protocol ID
- 022-114
- Acronym
- TAPS-ESP
- Status last verified
- Oct 2025
- First submitted
- 1 Jul 2022
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Gryczynski J, Sanchez K, Carswell SB, Schwartz RP. The Spanish language version of the TAPS tool: protocol for a validation and implementation study in primary care. Addict Sci Clin Pract. 2023 Nov 16;18(1):69. doi: 10.1186/s13722-023-00423-9.
PubMed 37974265
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tobacco, Alcohol, Prescription Drug, and Illicit Substance Use- Electronic Spanish Platform
- ClinicalTrials.gov ID
- NCT05476588
- Acronym / sponsor ID
- TAPS-ESP / 022-114
- Conditions
- Tobacco Use, Alcohol Abuse, Prescription Drug Abuse, Substance Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Collaborators
- COG Analytics
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 14 Mar 2024 (actual)
- Study completion
- 14 Mar 2024 (actual)
- First posted
- 27 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to validate the TAPS-ESP as a screen and assessment that can be used in primary care for the screening and treatment of substance use.
Detailed description
This Phase II study seeks to conduct further research to validate the TAPS-ESP as a Spanish language version of the screening and brief assessment and pave the way for its broad dissemination in the healthcare system. The investigators will use a novel application of a Type 1 hybrid effectiveness-implementation design, adapted to a screening validation study. The investigators will conduct a large-scale study to validate the TAPS-ESP against established diagnostic and biomarker metrics, replicating the design of the seminal English-language TAPS study.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized, two-group design.
| Arm | Type | Receives |
|---|---|---|
| Self-Administration followed by Interviewer-Administered | Active comparator | Other: ScreeningScreening and validation of assessment tool translated into Spanish |
| Interviewer-Administered followed by Self-Administration | Active comparator | Other: ScreeningScreening and validation of assessment tool translated into Spanish |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 or older
- Current patient of the clinic
- Spanish-language preferred
- Ability to read Spanish
Key exclusion criteria (3 listed)
- Unable to provide informed consent
- Inability to comprehend or read Spanish
- Inability to self-administer the iPad tool due to physical limitations
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 |
|---|---|---|
| ScreeningScreening and validation of assessment tool translated into Spanish | Other | Interviewer-Administered followed by Self-Administration, Self-Administration followed by Interviewer-Administered |
Primary outcome
Tobacco, Alcohol, Prescription drug, and illicit Substance Use Tool-Electronic Spanish Platform (TAPS-ESP) primary criterion validation against the modified World Mental Health Composite International Diagnostic Interview (CIDI) in Spanish
Time frame: 1 year
TAPS-ESP is a two-stage screening and assessment tool that first screens for 4 broad substance abuse categories (tobacco, alcohol, prescription drug misuse, and illicit substances), then branches to the assessment for specific risks related to an array of substances. TAPS-ESP scores will be validated against the modified World Mental Health Composite International Diagnostic Interview (CIDI) including alcohol, tobacco, and 9 substance categories. The CIDI items mapped to the diagnostic criteria for each substance will serve as the primary criterion standard for validation of the TAPS-ESP. For detecting CIDI-derived substance use disorder (SUD) diagnosis, we will examine TAPS-ESP cut-points for the 4-item screener and the assessment in detecting problem severity defined by CIDI for detecting different tiers of substance use: Problem use (1+ criteria), SUD (2+ criteria), and moderate-to-severe SUD (4-11 criteria). Detection of SUD will be the primary outcome for each substance category.
5 secondary outcomes
Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) for concurrent and convergent validity of the TAPS Tool
Time frame: 1 year
Drug Abuse Screening Test (DAST-10) for concurrent and convergent validity of the TAPS Tool
Time frame: 1 year
CAGE (Cut Down, Annoyed, Guilty, Eye-Opener) for concurrent and convergent validity of the TAPS
Time frame: 1 year
Alcohol Use Disorders Identification Test (AUDIT) for concurrent and convergent validity of the TAPS
Time frame: 1 year
Fagerstrom Test for Nicotine Dependence (FTND) for concurrent and convergent validity of the TAPS
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Derived from this study: PubMed 37974265Gryczynski J, Sanchez K, Carswell SB, Schwartz RP. The Spanish language version of the TAPS tool: protocol for a validation and implementation study in primary care. Addict Sci Clin Pract. 2023 Nov 16;18(1):69. doi: 10.1186/s13722-023-00423-9.
- Individual participant dataSharing planned: Yes
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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.
Katherine Sanchez, PhD principal investigator
Baylor Scott & White The Heart Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screening in people with Tobacco Use and Alcohol Abuse, run by Baylor Research Institute at 1 site 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 4 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 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Tobacco, Alcohol, Prescription drug, and illicit Substance Use Tool-Electronic Spanish Platform (TAPS-ESP) primary criterion validation against the modified World Mental Health Composite International Diagnostic Interview (CIDI) in Spanish (time frame: 1 year). 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 NCT05476588, which also lists 1 linked publication.
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 Jan 2026.