Substance Use Disorder
Conditions
Keywords
Substance Use, Substance Use Disorder, Screening, Brief Assessment
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.
Interventions
OTHERInterviewer 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.
Sponsors
National Institute on Drug Abuse (NIDA)
Johns Hopkins University
Virginia Commonwealth University
NYU Langone Health
Duke University
Friends Research Institute, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic and Statistical Manual-5 (DSM-5) Alcohol Use Disorder Diagnosis Measured by the Modified World Mental Health Composite International Diagnostic Interview | 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 | 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 | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| High Risk Tobacco Use Measured by the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) | 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). |
| Cannabis Positive Oral Fluid Test | baseline | Positive Oral Fluid Cannabis testing. |
| Unhealthy Cannabis Use | 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 |
| Risky Alcohol Use | 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). |
| Cigarette Smoking Risk | 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. |
| Smokeless Tobacco Questionnaire | baseline | Any yes response to smokeless tobacco use reported on the smokeless tobacco questionnaire is considered high risk. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Interviewer and Tablet Administration of TAPS Tool All participants self-administered TAPS Tool on a computer tablet and were administered the TAPS Tool by an interviewer | 2 |
| Total | 2 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Other | 1 | 0 |
| Overall Study | skipped assessment | 15 | 18 |
| Overall Study | technical difficulties | 6 | 4 |
| Overall Study | Withdrawal by Subject | 6 | 7 |
Baseline characteristics
| Characteristic | Interviewer and Tablet Administration of TAPS Tool |
|---|---|
| Age, Continuous | 46.0 years STANDARD_DEVIATION 14.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 233 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1761 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 12 Participants |
| Race (NIH/OMB) Asian | 35 Participants |
| Race (NIH/OMB) Black or African American | 1112 Participants |
| Race (NIH/OMB) More than one race | 66 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 108 Participants |
| Race (NIH/OMB) White | 667 Participants |
| Region of Enrollment United States | 2000 participants |
| Sex: Female, Male Female | 1124 Participants |
| Sex: Female, Male Male | 874 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 2,000 |
| other Total, other adverse events | 16 / 2,000 |
| serious Total, serious adverse events | 0 / 2,000 |
Outcome results
Primary
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
Time frame: Baseline
Population: Adult primary care patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Interviewer Administration | Diagnostic and Statistical Manual-5 (DSM-5) Alcohol Use Disorder Diagnosis Measured by the Modified World Mental Health Composite International Diagnostic Interview | .70 Sensitivity |
| Tablet Administration | Diagnostic and Statistical Manual-5 (DSM-5) Alcohol Use Disorder Diagnosis Measured by the Modified World Mental Health Composite International Diagnostic Interview | .74 Sensitivity |
Comparison: Each administration approach (interviewer and tablet) was tested separately against the reference measure.95% CI: [0.64, 0.75]
Comparison: Each administration approach (interviewer and tablet) was tested separately against the reference measure.95% CI: [0.68, 0.79]
Primary
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
Time frame: Baseline
Population: Adult primary care population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Interviewer Administration | Diagnostic and Statistical Manual-5 (DSM-5) Cannabis Use Disorder Diagnosis Measured With Modified World Mental Health Composite International Diagnostic Interview | 0.71 Sensitivity |
| Tablet Administration | Diagnostic and Statistical Manual-5 (DSM-5) Cannabis Use Disorder Diagnosis Measured With Modified World Mental Health Composite International Diagnostic Interview | .70 Sensitivity |
Comparison: Each administration approach (interviewer and tablet) were separately tested against the reference measure.95% CI: [0.63, 0.79]
Comparison: Each administration approach (interviewer and tablet) were separately tested against the reference measure.95% CI: [0.62, 0.77]
Primary
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
Time frame: Baseline
Population: Adult primary care patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Interviewer Administration | 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 | .57 Sensitivity |
| Tablet Administration | 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 | .60 Sensitivity |
Comparison: Each administration approach (interviewer and tablet) were tested separately against the reference measure.95% CI: [0.47, 0.67]
Comparison: Each administration approach (interviewer and tablet) were separately tested against the reference measure.95% CI: [0.5, 0.69]
Primary
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
Time frame: Baseline
Population: Adult primary care patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Interviewer Administration | Diagnostic and Statistical Manual DSM-5 Diagnosis of Heroin Use Disorder Measured by the The Modified World Mental Health Composite International Diagnostic Interview | .66 Sensitivity |
| Tablet Administration | Diagnostic and Statistical Manual DSM-5 Diagnosis of Heroin Use Disorder Measured by the The Modified World Mental Health Composite International Diagnostic Interview | .66 Sensitivity |
Comparison: Each administration approach (interviewer and tablet) were tested separately against the reference measure.95% CI: [0.53, 0.77]
Comparison: Each administration approach (interviewer and tablet) were tested separately against the reference measure.95% CI: [0.53, 0.77]
Primary
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
Time frame: Baseline
Population: adult primary care patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Interviewer Administration | Diagnostic and Statistical Manual DSM-5 Diagnosis of Tobacco Use Disorder Measured by the Modified World Mental Health Composite International Diagnostic Interview | .74 Sensivity |
| Tablet Administration | Diagnostic and Statistical Manual DSM-5 Diagnosis of Tobacco Use Disorder Measured by the Modified World Mental Health Composite International Diagnostic Interview | .73 Sensivity |
Secondary
Cannabis Positive Oral Fluid Test
Positive Oral Fluid Cannabis testing.
Time frame: baseline
Population: Adult Primary Care Patients with oral fluid test results
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Interviewer Administration | Cannabis Positive Oral Fluid Test | .42 Spearman Correlation |
| Tablet Administration | Cannabis Positive Oral Fluid Test | .40 Spearman Correlation |
Comparison: Each administration approach (interviewer and tablet) were tested separately against the reference measure.95% CI: [0.35, 0.48]
95% CI: [0.33, 0.46]
Secondary
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.
Time frame: baseline
Population: Adult Primary Care patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Interviewer Administration | Cigarette Smoking Risk | .73 Spearman Correlation |
| Tablet Administration | Cigarette Smoking Risk | .75 Spearman Correlation |
Secondary
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).
Time frame: Baseline
Population: Adult primary care patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Interviewer Administration | High Risk Tobacco Use Measured by the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) | .90 Sensitivity |
| Tablet Administration | High Risk Tobacco Use Measured by the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) | .90 Sensitivity |
Secondary
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).
Time frame: Baseline
Population: Adult Primary Care Patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Interviewer Administration | Risky Alcohol Use | .63 Spearman Correlation |
| Tablet Administration | Risky Alcohol Use | .64 Spearman Correlation |
Comparison: Each administration approach (interviewer and tablet) were tested separately against the reference measure.95% CI: [0.59, 0.66]
Comparison: Each administration approach (interviewer and tablet) was tested separately against the reference measure.95% CI: [0.61, 0.68]
Secondary
Smokeless Tobacco Questionnaire
Any yes response to smokeless tobacco use reported on the smokeless tobacco questionnaire is considered high risk.
Time frame: baseline
Population: Adult Primary Care patients
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Interviewer Administration | Smokeless Tobacco Questionnaire | .29 Spearman Correlation |
| Tablet Administration | Smokeless Tobacco Questionnaire | .28 Spearman Correlation |
Comparison: Each administration approach (interviewer and tablet computer) was tested separately against the reference measure.95% CI: [0.25, 0.33]
Comparison: Each administration approach (interviewer and tablet) were tested separately against the reference measure.95% CI: [0.24, 0.32]
Secondary
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
Time frame: Baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Interviewer Administration | Unhealthy Cannabis Use | .85 Spearman Correlation |
| Tablet Administration | Unhealthy Cannabis Use | .84 Spearman Correlation |