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Abstract: Background: The Tobacco, Alcohol, Prescription Medication, and Other Substance (TAPS) tool is a screening and brief assessment instrument to identify unhealthy tobacco, alcohol, drug use, and prescription medication use in primary care patients. This secondary analysis compares the TAPS tool to the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) for alcohol screening. Methods: Adult primary care patients (1124 female, 874 male) completed the TAPS tool followed by AUDIT-C. Performance of each instrument was evaluated against a reference standard measure, the modified World Mental Health Composite International Diagnostic Interview, to identify problem use and alcohol use disorder (AUD). Area under the curve (AUC) appraised discrimination, and sensitivity and specificity were calculated for Youden optimal score thresholds. Results: For identifying problem use: On the AUDIT-C, AUC was 0.90 (95% Confidence Interval: 0.86-0.92) for females and 0.91 (0.89-0.93) for males. Sensitivity and specificity for females were 0.89 (0.83-0.93) and 0.78 (0.75-0.80), respectively, and for males were 0.84 (0.79-0.88) and 0.82 (0.79-0.85). On the TAPS tool, AUC was 0.82 (0.79-0.86) for females and 0.81 (0.78-0.84) for males. Sensitivity and specificity for females were 0.78 (0.72-0.84) and 0.78 (0.75-0.81), respectively, and for males were 0.76 (0.71-0.81) and 0.76 (0.72-0.79). For AUD: On the AUDIT-C, AUC was 0.90 (0.88-0.93) for both females and males. Sensitivity and specificity for females were 0.83 (0.74-0.90) and 0.83 (0.80-0.85), respectively, while for males, they were 0.81 (0.74-0.87) and 0.84 (0.81-0.87). On the TAPS tool, AUC was 0.84 (0.80-0.89) for females and 0.82 (0.78-0.86) for males. Sensitivity and specificity for females were 0.73 (0.63-0.81) and 0.85 (0.83-0.88), respectively, while for males, they were 0.75 (0.68-0.81) and 0.84 (0.81-0.86). Conclusions: The AUDIT-C performed somewhat better than the TAPS tool for alcohol screening. However, the TAPS tool had an acceptable level of performance for alcohol screening and may be advantageous in practice settings seeking to identify alcohol and other substance use with a single instrument. Related protocols: CTN-0059

Abstract:

Objective: This secondary analysis evaluated the validation results of the Tobacco, Alcohol, Prescription Medication, and Other Substance Use (TAPS) tool for older adults.

Methods: Researchers performed a subgroup analysis of older adults aged =65 (n = 184) from the TAPS tool validation study conducted in 5 primary care clinics (CTN-0059). They compared the interviewer and self-administered versions of the TAPS tool at a cutoff of =1 for identifying problem use with a reference standard measure, the modified World Mental Health Composite International Diagnostic Interview.

Results: The mean age was 70.6 ± 5.9 years, 52.7% were female, and 49.5% were non-Hispanic Black. For identifying problem use, the self-administered TAPS tool had sensitivity of 0.91 (95% CI: 0.75–0.98) and specificity of 0.91 (95% CI: 0.85–0.95) for tobacco; sensitivity of 0.68 (95% CI: 0.45–0.86) and specificity of 0.88 (95% CI: 0.82–0.93) for alcohol; and sensitivity 0.86 (95% CI: 0.42–1.00) and specificity 0.94 (95% CI: 0.90–0.97) for cannabis. The interviewer-administered TAPS tool had similar results. Researchers were unable to evaluate its performance for identifying problem use of individual classes of drugs other than cannabis in this population due to small sample sizes.

Conclusions: While the TAPS had excellent sensitivity and specificity for identifying tobacco use among older adults, the results for other substances lack precision, and we were unable to evaluate its performance for prescription medications and individual illicit drugs in this sample. This analysis underlines the critical need to adapt and validate screening tools for unhealthy substance use, specifically for older populations who have unique risks.

Related protocols: CTN-0059

Abstract:

Primary care settings provide salient opportunities for identifying patients with problematic substance use and addressing unmet treatment needs. The aim of this study was to examine the extent and correlates of problematic substance use by substance-specific risk categories among primary care patients to inform screening/intervention efforts.

This secondary analysis of CTN-0059 (TAPS Tool) looked at data from 2000 adult primary care patients aged 18 or older (56% female) across 5 clinics in the eastern U.S. Participants completed the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST). Prevalence and ASSIST-defined risk-level of tobacco use, alcohol use, and nonmedical/illicit drug use was examined. Multinomial logistic regression models analyzed the demographic correlates of substance use risk-levels.

Among the total sample, the prevalence of any past 3-month use was 53.9% for alcohol, 42% for tobacco, 24.2% for any illicit/Rx drug, and 5.3% for opioids; the prevalence of ASSIST-defined moderate/high-risk use was 45.1% for tobacco, 29% for any illicit/Rx drug, 14.2% for alcohol, and 9.1% for opioids. Differences in the extent and risk-levels of substance use by sex, race/ethnicity, and age group were observed. Adjusted logistic regression showed that male sex, white race, not being married, and having less education were associated with increased odds of moderate/high-risk use scores for each substance category; older ages (versus ages 18-25 years) were associated with increased odds of moderate/high-risk opioid use.

Conclusions: Intervention need for problematic substance use was prevalent in this sample. Providers should maintain awareness and screen for problematic substance use more consistently in identified high risk populations.

Related protocols: CTN-0059

Abstract:

The application of digital technologies to better assess, understand, and treat substance use disorders (SUDs) is a particularly promising and vibrant area of scientific research. The National Drug Abuse Treatment Clinical Trials Network (CTN), launched in 1999 by the U.S. National Institute on Drug Abuse, has supported a growing line of research that leverages digital technologies to glean new insights into SUDs and provide science-based therapeutic tools to a diverse array of persons with SUDs.

This article provides an overview of the breadth and impact of research conducted in the realm of digital health within the CTN. This work has included the CTN’s efforts to systematically embed digital screeners for SUDs into general medical settings to impact care models across the nation. This work has also included a pivotal multi-site clinical trial conducted on the CTN platform, whose data led to the very first “prescription digital therapeutic” authorized by the U.S. Food and Drug Administration (FDA) for the treatment of SUDs. Further CTN research includes the study of telehealth to increase capacity for science-based SUD treatment in rural and under-resourced communities. In addition, the CTN has supported an assessment of the feasibility of detecting cocaine-taking behavior via smartwatch sensing. And, the CTN has supported the conduct of clinical trials entirely online (including the recruitment of national and hard-to-reach/under-served participant samples online, with remote intervention delivery and data collection). Further, the CTN is supporting innovative work focused on the use of digital health technologies and data analytics to identify digital biomarkers and understand the clinical trajectories of individuals receiving medications for opioid use disorder (OUD).

This paper concludes by outlining the many potential future opportunities to leverage the unique national CTN research network to scale-up the science on digital health to examine optimal strategies to increase the reach of science-based SUD service delivery models both within and outside of healthcare.

Related protocols: CTN-0044, CTN-0059, CTN-0073-Ot, CTN-0076, CTN-0083, CTN-0084-A-2, CTN-0090, CTN-0095, CTN-0101, CTN-0102

Abstract:

Timeline Follow-back (TLFB) interviews using self-report are often used to assess substance use. Oral fluid testing (OFT) offers an objective measure of substance use. There are limited data on the agreement between TLFB and OFT.

In this secondary analysis of data from CTN-0059 (TAPS Tool), a multisite study in five primary care sites, self-reported TLFB and OFT data collected under confidential conditions were compared to assess concordance (N=1799). OFT samples were analyzed for marijuana, heroin, cocaine, and non-medical use of prescription opioids. Demographic differences in discordance relative to TLFB and OFT concordant results for marijuana, the only substance with an adequate sample size in this analysis, were examined using multinomial logistic regression.

Overall concordance rates between TLFB and OFT were 94.9 % or higher for each substance, driven by large subgroups with no use. Among participants with discordant use, marijuana was the only substance with lower detection on OFT than self-report (27.6 % OFT-positive only vs 32.2 % TLFB-positive only), whereas cocaine (65.6 % vs 8.6 %), prescription opioids (90.4 % vs 6.0 %), and heroin (40.7 % vs 26.0 %) all had higher detection via OFT than TLFB. Participants who reported marijuana use but had a negative OFT were more likely to be younger, Hispanic, and White compared to those with TLFB and OFT concordant positive results.

Conclusions: TLFB and OFT show disparate detection of different substances. Researchers should consider the implications of using either self-report or oral fluid testing in isolation, depending on the substance and collection setting. Triangulating multiple sources of information may improve detection of drug use.

Related protocols: CTN-0059

Abstract:

The TAPS Tool is a substance use screening and brief assessment instrument that was developed for use in primary care medical settings. It is one of the first screening instruments to provide rapid assessment of all commonly used substance classes, including illicit and prescription opioids, and is one of the only available screeners designed and validated in an electronic self-administered format (myTAPS). This secondary analysis of data from the TAPS Tool validation study (CTN-0059) describes the feasibility and acceptability of the myTAPS among primary care patients.

Adult patients (N=2000) from five primary care clinics completed the TAPS Tool on a tablet computer (myTAPS) and in an interviewer-administered format. Requests for assistance and time required were tracked, and participants completed a survey on ease of use, utilization of audio guidance, and format preference. Logistic regression was used to examine outcomes in defined subpopulations, including groups that may have greater difficulty completing an electronic screener and those that may prefer an electronic self-administered approach.

Almost all participants (98.3%) reported that the myTAPS was easy to use. The median time to complete myTAPS screening was 4 minutes (mean 4.48, standard deviation 2.57). More time was required by participants who were older, Hispanic, Black, or reported non-medical prescription drug use, while less time was required by women. Assistance was requested by 25% of participants and was more frequently requested by those with lower education or who were over the age of 65. Audio guidance was used by 18.3% and was more frequently used by participants with lower education, who were over 65, or of Black race. The myTAPS format was preferred by women and individuals with drug use, while participants with lower education preferred the interviewer-administered format.

Conclusions: Overall, myTAPS screening was feasible and well accepted by adult primary care patients. Clinics adopting electronic screening should be prepared to offer assistance to some patients, particularly those who are older or less educated, and should have the capacity to use an interviewer-administered approach when required. Future studies should assess the acceptability and the feasibility of myTAPS screening when it is implemented in routine practice.

Related protocols: CTN-0059

Abstract:

Current data suggest that opioid misuse or opioid use disorder (OUD) may be over-represented among tobacco users. However, this association remains understudied in primary care settings. A better understanding of the extent of heterogeneity in opioid misuse among primary care patients who use tobacco may have implications for improved primary care-based screening, prevention, and intervention approaches. This study assessed the prevalence of opioid misuse and OUD by sociodemographic characteristics and past-year polysubstance use among a sample of 2000 adult (aged 18+) primary care patients across 5 distinct clinics (CTN-0059: the TAP Tool study). Latent class analysis (LCA) was used to identify heterogeneous subgroups of tobacco users according to past-year polysubstance use patterns. Multinomial logistic regression was used to examine variables associated with LCA-defined class membership.

Results found that past-year tobacco use was reported by >84% of participants who reported past-year opioid misuse or OUD. Among those reporting past-year tobacco use, the prevalence of past-year opioid misuse and OUD was 14% and 9.5%, respectively. The prevalence of opioid misuse or OUD was highest among tobacco users who were male or unemployed. Three LCA-defined classes among tobacco users were identified including a tobacco-minimal drug use group (78%), a tobacco-cannabis group (10.1%), and a tobacco-opioid/polydrug use group (11.9%). Class membership differed by sociodemographic characteristics.

Conclusions: Results from this study support the benefit of more comprehensive assessment of and/or monitoring for opioid misuse among primary care patients who use tobacco, particularly for those who are male, unemployed, or polydrug users. Primary care providers should not only recognize the association between tobacco use and opioid misuse, but also the differential liability of misuse among some patient subgroups, which may be used to inform prevention or early intervention groups.

Related protocols: CTN-0059

Abstract:

Addressing multiple substance use disorders (SUDs) in primary care-based screening and intervention may improve SUD treatment access, engagement, and outcomes. To inform such efforts, research is needed on the prevalence and patterns of multiple SUDs among primary care patients. Data were analyzed from a sample of 2,000 adult (aged 18 or older) primary care patients recruited from a multisite NIDA Clinical Trials Network (CTN) study (CTN-0059). Past-year DSM-5 SUDs (tobacco, alcohol, and drug) were assessed by the modified Composite International Diagnostic Interview. Prevalence and correlates of multiple versus single SUDs were examined. Latent class analysis (LCA) was used to explore patterns of multiple SUDs.

Analysis revealed multiple SUDs among the majority of patients with SUD for alcohol, cannabis, prescription opioids, cocaine, and heroin. Participants who were male, ages 26-34, less educated, and unemployed had increased odds of multiple SUDs compared to one SUD. Having multiple SUDs was associated with greater severity of tobacco or alcohol use disorder. LCA of the sample identified three classes: class 1 (83.7%) exhibited low prevalence of all SUDs; class 2 (12%) had high-moderate prevalence of SUDs for tobacco, alcohol, and cannabis; class 3 (4.3%) showed high prevalence of SUD for tobacco, opioids, and cocaine. LCA-defined classes were distinguished by sex, age, race, education, and employment status.

Conclusions: Findings suggest that multiple SUDs are the norm rather than the exception among primary care patients with SUD. Primary care physicians should be aware of multiple SUDs when planning treatment, especially among adults who are male, younger, less educated, or unemployed. However, it should be noted that the treatment and management of multiple SUDs and other associated comorbidities may be out of the scope of expertise for many primary care physicians. This argues for the need of additional approaches to address SUD in primary care, such as the development of coordinated care models and linkage services to improve access to specialty care and follow-up of clinical outcomes.

Related protocols: CTN-0059

Abstract:

Tobacco, alcohol, and drug use are leading causes of preventable death in the U.S., but screening for alcohol and drug use is not part of routine health care and substance use information is not systematically collected in electronic health records.

This presentation described two protocols in the CTN that aimed to address this issue: CTN-0059, in which the TAPS Tool for screening and brief assessment was developed and validated, and CTN-0062, a feasibility and proof-of-concept study to assess incorporating the NIDA CTN Common Data Elements into electronic health records in large primary care settings.

Related protocols: CTN-0059, CTN-0062-Ot

Abstract:

The Tobacco, Alcohol, Prescription Medication, and Other Substance use (TAPS) tool is a combined two-part screening and brief assessment developed for adult primary care patients. The tool’s first-stage screening component (TAPS-1) consists of four items asking about past 12-month use for four substance categories, with response options of never, less than monthly, monthly, weekly, and daily or almost daily.

The TAPS tool was recently validated in primary care by the National Drug Abuse Treatment Clinical Trials Network (NIDA CTN-0059). The purpose of the present study was to examine the ability of the TAPS-1, using the dataset from the original study, as a standalone screener to identify adult primary care patients with unhealthy substance use.

Two thousand adult patients at 5 primary care sites completed the TAPS tool in self- and interviewer-administered formats, in random order. In this secondary analysis, the TAPS-1 was evaluated against DSM-5 substance use disorder (SUD) criteria to determine optimal cut-points for identifying unhealthy substance use at there severity levels (problem use, mild SUD, and moderate-to-severe DUS).

Results found that optimal frequency-of-use cut-points on the self-administered TAPS-1 for identifying SUDs were less-than-or-equal-to monthly use for tobacco and alcohol (sensitivity = 0.92 and 0.71, specificity = 0.80 and 0.85, AUC = 0.86 and 0.78, respectively) and any reported use for illicit drugs and prescription medication misuse (sensitivity = 0.93 and 0.89, specificity = 0.85 and 0.91, AUC = 0.89 and 0.90, respectively). The performance of the interviewer-administered format was similar. When administered first, the self-administered format yielded higher disclosure rates for past 12-month alcohol use, illicit drug use, and prescription medication misuse. Frequency of use alone did not provide sufficient information to discriminate between gradations of substance use problem severity. Among those who denied drug use on the TAPS-1, less than 4% had a drug-positive biomarker.

Conclusions: This study demonstrated the validity of the TAPS-1 in both interviewer- and self-administered formats, with the self-administered format demonstrating slightly higher levels of disclosure of substance use. The findings from the current study support the use of the TAPS-1 for rapid patient triage to help inform a more detailed clinical assessment.

Related protocols: CTN-0059

Abstract:

There are limited data about the extent of DSM-5 substance use disorders (SUDs) among primary care patients. This study analyzed data from a multisite validation study of a substance use screening instrument conducted in a diverse sample of 2,000 adults aged 18 or older recruited from five primary care practices in four states, NIDA Clinical Trials Network protocol CTN-0059, the TAPS Tool study. Prevalence and correlates of 12-month DSM-5 SUDs were examined. Results found that overall, 75.5% of the sample used any substance, including alcohol (62%), tobacco (44.1%), or illicit drugs/nonmedical medications (27.9%) in the past 12 months (marijuana 20.8%, cocaine 7.3%, opioids 4.8%, sedatives 4.1%, heroin 3.9%). The prevalence of any 12-month SUD was 36% (mild disorder 14.2%, moderate/severe disorder 21.8%): tobacco 25.3% (mild 11.5%, moderate/severe 13.8%); alcohol 13.9% (mild 6.9%, moderate/severe 7%); and any illicit/nonmedical drug 14% (mild 4%, moderate/severe 10%). Among past 12-month users, a high proportion of tobacco and drug users met criteria for a disorder: tobacco use disorder 57.4% (26.1% mild, 31.3% moderate/severe) and any drug use disorder 50.2% (14.3% mild, 35.8% moderate/severe); a lower proportion of alcohol users (22.4%) met criteria for alcohol use disorder (11.1% mild, 11.3% moderate/severe). Over 80% of adults with opioid/heroin use disorder met criteria for a moderate/severe disorder. Younger ages, male sex, and low education were associated with increased odds of having SUD.

Conclusions: Given the national movement toward the integration of primary care and SUD treatment, these findings have implications for clinical practice. Twelve-month SUDs were prevalent among primary care patients in this sample, which highlights a need to improve primary care providers’ training and willingness to provide screening and treatment for SUD. To improve that integration, research is needed to inform primary care physicians’ willingness to use validated tools for screening substance misuse, identify effective approaches for addressing SUDs in medical settings, and engage patients into SUD treatment.

Related protocols: CTN-0059

Abstract:

There is a need for screening and brief assessment instruments to identify primary care patients with substance use problems. This study’s aim was to examine the performance of a two-step screening and brief assessment instrument, the TAPS Tool, compared to the WHO ASSIST. Two thousand adult primary care patients recruited from five primary care clinics in four Eastern US states completed the TAPS Tool followed by the ASSIST. The ability of the TAPS Tool to identify moderate- and high-risk use scores on the ASSIST was examined using sensitivity and specificity analyses.

The interviewer and self-administered computer tablet versions of the TAPS Tool generated similar results. The interviewer-administered version (at cut-off of 2) had acceptable sensitivity and specificity for high-risk tobacco (0.90 and 0.77) and alcohol (0.87 and 0.80) use. For illicit drugs, sensitivities were >0.82 and specificities >0.92. The TAPS (at cut-off of 1) had good sensitivity and specificity for moderate-risk tobacco use (0.83 and 0.97) and alcohol (0.83 and 0.74). Among illicit drugs, sensitivity was acceptable for moderate-risk of marijuana (0.71), while it was low for all other illicit drugs and non-medical use of prescription medications. Specificities were 0.87 or higher for all illicit drugs and prescription medications.

Conclusions: The TAPS Tool identified adult primary care patients with high-risk ASSIST scores for all substances as well as moderate-risk users of tobacco, alcohol, and marijuana, although it did not perform well in identifying patients with moderate-risk use of other drugs or non-medical use of prescription medications. The advantages of the TAPS Tool over the ASSIST are its more limited number of items and focus solely on substance use in the past 3 months. The TAPS Tool score provides the primary care physician with a window into current drug use and problems, and is an alternative to the longer version of the ASSIST.

Related protocols: CTN-0059

Abstract:

This is the primary outcomes article for CTN-0059.

Substance use, a leading cause of illness and death, is under-identified in medical practice. The Tobacco, Alcohol, Prescription Medication, and Other Substance Use (TAPS) tool was developed to address the need for a brief screening and assessment instrument that includes all commonly used substances and fits into clinical workflows. The goal of this multisite study conducted within the NIDA Clinical Trials Network, CTN-0059, was to assess the performance of the TAPS tool in primary care patients by comparing it with a reference standard measure, the modified World Mental Health Composite International Diagnostic Interview (CIDI), which measures problem use and substance use disorder (SUD).

The study was conducted at 5 adult primary care clinics with 2000 adult patients consecutively recruited from clinic waiting areas. Results found that interviewer- and self-administered versions of the TAPS tool had similar diagnostic characteristics. For identifying problem use (at a cutoff of 1+), the TAPS tool had a sensitivity of 0.93 (95%CI, 0.90 to 0.95) and specificity of 0.87 (CI, 0.85 to 0.89) for tobacco and a sensitivity of 0.74 (CI, 0.70 to 0.78) and specificity of 0.79 (CI, 0.76 to 0.81) for alcohol. For problem use of illicit and prescription drugs, sensitivity ranged from 0.82 (CI, 0.76 to 0.87) for marijuana to 0.63 (CI, 0.47 to 0.78) for sedatives; specificity was 0.93 or higher. For identifying any SUD (at a cutoff of 2+), sensitivity was lower.

Limitations of this study included the low prevalence of some drug classes, leading to poor precision in some estimates. Also, research assistants were not blinded to participants’ TAPS tool responses when they administered the CIDI.

Conclusions: Having information about a patient’s substance use is essential for ensuring the quality and safety of medical care. This study supports the use of the TAPS tool (at a cutoff of 1+) in screening diverse populations of adult primary care patients for problem substance use. Although it may detect tobacco, alcohol, and marijuana use disorders, further refinement is needed before it can be recommended broadly for SUD screening. Because it asks a limited number of questions to identify problem use of all commonly used substances and has the flexibility to be either self-administered or completed as an interview, the TAPS tool has the potential to ease barriers to incorporating substance use screening into busy clinical environments.

Related protocols: CTN-0059

Abstract:

Substance use and its associated use disorders are under-detected and under-treated in primary care. There is a need for a clinically useful brief screening and assessment instrument to identify primary care patients with substance use, sub-threshold substance use disorder (SUD), and SUD to facilitate brief intervention and treatment. This article describes the design of the recently completed NIDA Clinical Trials Network’s “Tobacco, Alcohol, Prescription Medications, and Substance Use/Misuse Brief Screen/Assessment Tool” validation study (CTN-0059). Study aims included to:

develop a 2-stage screening and brief assessment tool (TAPS Tool) to detect substance use, problem use, and SUD among adult primary care patients

examine the validity of both the screen component and the TAPS Tool by comparing them to reference standard screening and assessment measures of no use, problem use, and SUD; and

determine the feasibility and acceptability of the self-administration and interviewer-administration of the tool.

The design included a pilot testing phase (n=30) and the main study of 2,000 adult primary care participants who were randomly assigned in counter-balanced order to have the interviewer-administration or the self-administration of the TAPS Tool followed by the other administration format. Participants’ views of feasibility, acceptability and preference for format of self-administration versus interviewer-administration of the TAPS Tool were assessed. Criterion measures of use and DSM-5 SUDs were administered.

The TAPS Tool study builds on prior work to develop a 2-stage clinical tool for facilitating the adoption of screening, brief assessment and treatment for SUDs in primary care. The Tool is poised to make a unique contribution to the field in multiple ways, and addresses a timely need to develop a quick screen for early identification of substance use disorders and an assessment tool for detection of risk levels of substance use to inform optimal clinical management among adults in primary care settings.

Related protocols: CTN-0059