Browsing by Author "Schwartz, Robert P"
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Item Open Access A Brief Screening and Assessment Tool for Opioid Use in Adults: Results from a Validation Study of the Tobacco, Alcohol, Prescription Medication, and Other Substances Tool.(Journal of addiction medicine, 2023-02) Bunting, Amanda M; Schwartz, Robert P; Wu, Li-Tzy; Wahle, Aimee; Kline, Margaret; Subramaniam, Geetha; McNeely, JenniferObjectives
This secondary analysis evaluated opioid-specific validation results of the Tobacco, Alcohol, Prescription Medication, and Other Substances (TAPS) tool for screening in primary care.Methods
This study is a secondary data analysis of the TAPS validation study. Performance of the TAPS tool for screening for unhealthy opioid use (with a score of 1+ for heroin and/or prescription opioids representing a positive screen) was evaluated. Discriminative ability was examined in comparison with reference standard measures across the spectrum of unhealthy opioid use: timeline follow-back with and without oral fluid testing identifying past-month use and the modified Composite International Diagnostic Interview for past-year problem use, opioid use disorder (OUD), and moderate-severe OUD.Results
In a sample of 2000 primary care patients, 114 screened positive for opioids on the TAPS tool. With a TAPS cutoff equal to 1+, the TAPS accurately identified past-month use, problem use, any OUD, and moderate-severe OUD (sensitivities = 68%-85%, specificities = 97%-98%, area under the curve = 0.80-0.91). When past-month use was expanded to include timeline follow-back with oral fluid testing, accuracy declined (52% sensitivity [95% confidence interval, 43%-60%], 98% specific [95% confidence interval, 97%-98%]).Conclusions
While further testing in a larger population sample may be warranted, given their brevity, simplicity, and accuracy when self-administered, the TAPS opioid items can be used in primary care settings for a spectrum of unhealthy opioid use; however, self-disclosure remains an issue in primary care settings.Item Open Access A Brief Screening and Assessment Tool for Opioid Use in Adults: Results from a Validation Study of the Tobacco, Alcohol, Prescription Medication, and Other Substances Tool.(Journal of addiction medicine, 2023-07) Bunting, Amanda M; Schwartz, Robert P; Wu, Li-Tzy; Wahle, Aimee; Kline, Margaret; Subramaniam, Geetha; McNeely, JenniferObjectives
This secondary analysis evaluated opioid-specific validation results of the Tobacco, Alcohol, Prescription Medication, and Other Substances (TAPS) tool for screening in primary care.Methods
This study is a secondary data analysis of the TAPS validation study. Performance of the TAPS tool for screening for unhealthy opioid use (with a score of 1+ for heroin and/or prescription opioids representing a positive screen) was evaluated. Discriminative ability was examined in comparison with reference standard measures across the spectrum of unhealthy opioid use: timeline follow-back with and without oral fluid testing identifying past-month use and the modified Composite International Diagnostic Interview for past-year problem use, opioid use disorder (OUD), and moderate-severe OUD.Results
In a sample of 2000 primary care patients, 114 screened positive for opioids on the TAPS tool. With a TAPS cutoff equal to 1+, the TAPS accurately identified past-month use, problem use, any OUD, and moderate-severe OUD (sensitivities = 68%-85%, specificities = 97%-98%, area under the curve = 0.80-0.91). When past-month use was expanded to include timeline follow-back with oral fluid testing, accuracy declined (52% sensitivity [95% confidence interval, 43%-60%], 98% specific [95% confidence interval, 97%-98%]).Conclusions
While further testing in a larger population sample may be warranted, given their brevity, simplicity, and accuracy when self-administered, the TAPS opioid items can be used in primary care settings for a spectrum of unhealthy opioid use; however, self-disclosure remains an issue in primary care settings.Item Open Access Comparison of timeline follow-back self-report and oral fluid testing to detect substance use in adult primary care patients.(Drug and alcohol dependence, 2020-02-22) Nordeck, Courtney D; Gryczynski, Jan; O'Grady, Kevin E; Polak, Kathryn; Svikis, Dace S; McNeely, Jennifer; Wu, Li-Tzy; Schwartz, Robert PBACKGROUND: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. METHODS:In this secondary analysis from 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. RESULTS: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.Item Open Access Core outcomes set for research on the treatment of opioid use disorder (COS-OUD): the National Institute on Drug Abuse Clinical Trials Network protocol for an e-Delphi consensus study.(Trials, 2021-01-28) Karnik, Niranjan S; Campbell, Cynthia I; Curtis, Megan E; Fiellin, David A; Ghitza, Udi; Hefner, Kathryn; Hser, Yih-Ing; McHugh, R Kathryn; Murphy, Sean M; McPherson, Sterling M; Moran, Landhing; Mooney, Larissa J; Wu, Li-Tzy; Shmueli-Blumberg, Dikla; Shulman, Matisyahu; Schwartz, Robert P; Stephens, Kari A; Watkins, Katherine E; Marsden, JohnBackground
A lack of consensus on the optimal outcome measures to assess the efficacy and effectiveness of interventions for the treatment of opioid use disorder (OUD) has hampered the pooling of research data for evidence synthesis and clinical guidelines. A core outcome set (COS) is a minimum set of outcome measures that are recommended for all studies of a particular condition. The National Drug Abuse Treatment Clinical Trials Network (CTN) Core Outcome Set for OUD (COS-OUD) is a development study to identify core constructs, meaningful outcomes, and their optimal measurement for all efficacy and effectiveness studies of OUD treatment and service delivery.Methods/design
Overseen by an expert workgroup, a modified, stepwise, e-Delphi methodology will be used to gain consensus among a panel of clinical practitioners and researchers involved in the treatment of OUD, who are members of the CTN. Sequential rounds of anonymous, online questionnaires will be used to identify, rate the importance of, and refine a core outcome set. A consensus threshold will be achieved if at least 70% of the panel rate the measure as critical for inclusion in the COS-OUD. Where consensus is not reached or there are suggestions for new measures, these will be brought forward to a further round of review prior to a consensus meeting. Products from this study will be communicated via peer-reviewed scientific journals and conferences.Discussion
This initiative will develop a COS for OUD intervention trials, treatment studies, and service delivery and will support the pooling of research and clinical practice data and efforts to develop measurement-based care within the OUD treatment cascade.Trial registration
http://www.comet-initiative.org/Studies/Details/1579.Item Open Access Corrigendum to "Design of the NIDA clinical trials network validation study of tobacco, alcohol, prescription medications, and substance use/misuse (TAPS) tool" [Contemporary Clinical Trials. 2016 Jul. 19; 50: 90-97].(Contemp Clin Trials, 2016-11) Wu, Li-Tzy; McNeely, Jennifer; Subramaniam, Geetha A; Sharma, Gaurav; VanVeldhuisen, Paul; Schwartz, Robert PItem Open Access Design of the NIDA clinical trials network validation study of tobacco, alcohol, prescription medications, and substance use/misuse (TAPS) tool.(Contemporary clinical trials, 2016-09) Wu, Li-Tzy; McNeely, Jennifer; Subramaniam, Geetha A; Sharma, Gaurav; VanVeldhuisen, Paul; Schwartz, Robert PSubstance 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.We describe the design of the recently completed National Drug Abuse Treatment Clinical Trials Network's tobacco, alcohol, prescription medications, and substance use/misuse screen and brief assessment tool validation study. 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 2000 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.Item Open Access DSM-5 substance use disorders among adult primary care patients: Results from a multisite study.(Drug and alcohol dependence, 2017-10) Wu, Li-Tzy; McNeely, Jennifer; Subramaniam, Geetha A; Brady, Kathleen T; Sharma, Gaurav; VanVeldhuisen, Paul; Zhu, He; Schwartz, Robert PBACKGROUND:There are limited data about the extent of DSM-5 substance use disorders (SUDs) among primary care patients. METHODS:This study analyzed data from a multisite validation study of a substance use screening instrument conducted in a diverse sample of 2000 adults aged ≥18 years recruited from five primary care practices in four states. Prevalence and correlates of 12-month DSM-5 SUDs were examined. RESULTS:Overall, 75.5% of the sample used any substance, including alcohol (62.0%), 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 36.0% (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 7.0%); and any illicit/nonmedical drug 14.0% (mild 4.0%, moderate/severe 10.0%). Among past 12-month users, a high proportion of tobacco or 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. CONCLUSION:These findings reveal the high prevalence of SUDs in primary care and underscore the need to identify and address them.Item Open Access E-Cigarette Use Among Adult Primary Care Patients: Results from a Multisite Study.(Journal of general internal medicine, 2020-01) John, William S; Grover, Kiran; Greenblatt, Lawrence H; Schwartz, Robert P; Wu, Li-TzyBACKGROUND:Primary care settings provide opportunities to identify electronic-cigarette (e-cigarette) use and to implement strategies for changing tobacco use behavior. However, a better understanding of the extent and associated characteristics of e-cigarette use among primary care patients are needed to inform such efforts. OBJECTIVE:To describe patient demographic and substance use characteristics by e-cigarette use status among a large sample of primary care patients. To examine the prevalence and correlates of e-cigarette use among tobacco users in the sample. DESIGN:Cross-sectional analysis from a multisite validation study of a substance use screening instrument. PARTICIPANTS:Adult primary care patients aged 18 and older (n = 2000) recruited across 5 primary care clinics in the Eastern USA from 2014 to 2015. MAIN MEASURES:Patients reported past 3-month e-cigarette use, sociodemographics, tobacco use, and other substance use. Current nicotine dependence and DSM-5 criteria for past-year substance use disorders were also assessed. KEY RESULTS:Among the total sample, 7.7% (n = 154) adults reported past 3-month e-cigarette use. Adults who reported e-cigarette use (vs. no use) were more likely to be younger, white, or have frequent tobacco use, nicotine dependence, or past-year illicit drug use/disorders. Among past 3-month tobacco users, 16.3% reported e-cigarette use. Adjusted logistic regression indicated that odds of e-cigarette use were greater among tobacco users who had some college education or more (vs. < high school) or were daily/almost daily tobacco users (vs. not); odds were lower among Blacks/African-Americans (vs. whites). E-cigarette use among tobacco users was associated with increased odds of current nicotine dependence or tobacco use disorder as well as more severe dependence/disorder. CONCLUSIONS:Enhanced surveillance of e-cigarette use among adult tobacco users in primary care, particularly among those who use tobacco frequently, may have implications for helping patients with tobacco cessation using established approaches including behavioral support, pharmacotherapy, or referral to specialized care.Item Open Access Electronic self-administered screening for substance use in adult primary care patients: feasibility and acceptability of the tobacco, alcohol, prescription medication, and other substance use (myTAPS) screening tool(Addiction Science & Clinical Practice, 2019-12) Adam, Angéline; Schwartz, Robert P; Wu, Li-Tzy; Subramaniam, Geetha; Laska, Eugene; Sharma, Gaurav; Mili, Saima; McNeely, JenniferItem Open Access Opioid treatment program and community pharmacy collaboration for methadone maintenance treatment: results from a feasibility clinical trial.(Addiction (Abingdon, England), 2021-07-19) Wu, Li-Tzy; John, William S; Morse, Eric D; Adkins, Steve; Pippin, Jennifer; Brooner, Robert K; Schwartz, Robert PBackground and aims
Pharmacy administration and dispensing of methadone for methadone maintenance treatment (MMT) can expand treatment access for opioid use disorder (OUD). This study investigated the feasibility and acceptability of a novel model permitting an opioid treatment program (OTP) physician to prescribe methadone for OUD treatment through collaboration with a partnered pharmacy.Design
Non-randomized, single-arm, open-label feasibility trial.Setting
One OTP and one community pharmacy in the United States.Participants
One OTP physician, two pharmacists and 20 MMT patients receiving between six and 13 take-home methadone doses at 5-160 mg/day.Intervention
Patients' methadone administration and dispensing of take-home doses was transferred from the OTP to the pharmacy for 3 months.Measurements
Primary outcome was medication adherence. Secondary outcomes were recruitment, treatment retention, substance use, counseling attendance at the OTP, pharmacist prescription drug monitoring program (PDMP) use, safety and satisfaction.Findings
Of 29 patients eligible at pre-screen, 20 patients (69%) enrolled into the study. Recruitment occurred from 6 August 2020 to 10 October 2020. Treatment retention rate at month 3 was 80% (16 of 20). Two participants returned early to the OTP because of a work/schedule change, one due to pregnancy and one following a non-study-related hospitalization. Medication adherence among 16 patients who were retained was 100%. Intervention fidelity was 100%. All participants attended random call-back visits. None showed evidence of tampering/diversion of methadone. Pharmacists checked the PDMP at all visits. All participants attended psychosocial counseling as planned. There were no positive urine screens for illicit opioid use and no study-related adverse events. All participants endorsed 'pharmacy is the right location for receiving methadone for MMT', 88% endorsed 'convenient or very convenient to receive methadone at the pharmacy' and 88% were satisfied or very satisfied with the quality of treatment offered.Conclusions
This feasibility trial has found pharmacy administration and dispensing of physician-prescribed methadone for methadone maintenance treatment to be feasible and acceptable.Item Open Access Patient perspectives on community pharmacy administered and dispensing of methadone treatment for opioid use disorder: a qualitative study in the U.S.(Addiction science & clinical practice, 2023-08) Wu, Li-Tzy; John, William S; Mannelli, Paolo; Morse, Eric D; Anderson, Alyssa; Schwartz, Robert PBackground
Pharmacy administration and dispensing of methadone treatment for opioid use disorder (PADMOUD) may address inadequate capability of opioid treatment programs (OTPs) in the US by expanding access to methadone at community pharmacies nationally. PADMOUD is vastly underutilized in the US. There is no published US study on OUD patients' perspectives on PADMOUD. Data are timely and needed to inform the implementation of PADMOUD in the US to address its serious opioid overdose crisis.Methods
Patient participants of the first completed US trial on PADMOUD through electronic prescribing for methadone (parent study) were interviewed to explore implementation-related factors for PADMOUD. All 20 participants of the parent study were invited to participate in this interview study. Each interview was recorded and transcribed verbatim. Thematic analysis was conducted to identify emergent themes.Results
Seventeen participants completed the interview. Patients' perspectives on PADMOUD were grouped into five areas. Participants reported feasibility of taking the tablet formulation of methadone at the pharmacy and identified benefits from PADMOUD (e.g., better access, efficiency, convenience) compared with usual care at the OTP. Participants perceived support for PADMOUD from their family/friends, OTP staff, and pharmacy staff. PADMOUD was perceived to be a great option for stable patients with take-home doses and those with transportation barriers. The distance (convenience), office hours, and the cost were considered factors most influencing their decision to receive methadone from a pharmacy. Nonjudgmental communication, pharmacists' training on methadone treatment, selection of patients (stable status), workflow of PADMOUD, and protection of privacy were considered key factors for improving operations of PADMOUD.Conclusion
This study presents the first findings on patient perspectives on PADMOUD. Participants considered pharmacies more accessible than OTPs, which could encourage more people to receive methadone treatment earlier and help transition stable patients from an OTP into a local pharmacy. The findings have timely implications for informing implementation strategies of PADMOUD that consider patients' views and needs.Item Metadata only Performance of the Tobacco, Alcohol, Prescription Medication, and Other Substance Use (TAPS) Tool for Substance Use Screening in Primary Care Patients.(Ann Intern Med, 2016-11-15) McNeely, Jennifer; Wu, Li-Tzy; Subramaniam, Geetha; Sharma, Gaurav; Cathers, Lauretta A; Svikis, Dace; Sleiter, Luke; Russell, Linnea; Nordeck, Courtney; Sharma, Anjalee; O'Grady, Kevin E; Bouk, Leah B; Cushing, Carol; King, Jacqueline; Wahle, Aimee; Schwartz, Robert PBackground: Substance use, a leading cause of illness and death, is underidentified in medical practice. Objective: 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 study was to assess the performance of the TAPS tool in primary care patients. Design: Multisite study, conducted within the National Drug Abuse Treatment Clinical Trials Network, comparing the TAPS tool with a reference standard measure. (ClinicalTrials.gov: NCT02110693). Setting: 5 adult primary care clinics. Participants: 2000 adult patients consecutively recruited from clinic waiting areas. Measurements: Interviewer- and self-administered versions of the TAPS tool were compared with a reference standard, the modified World Mental Health Composite International Diagnostic Interview (CIDI), which measures problem use and substance use disorder (SUD). Results: 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: The low prevalence of some drug classes led to poor precision in some estimates. Research assistants were not blinded to participants' TAPS tool responses when they administered the CIDI. Conclusion: In a diverse population of adult primary care patients, the TAPS tool detected clinically relevant problem substance use. Although it also may detect tobacco, alcohol, and marijuana use disorders, further refinement is needed before it can be recommended broadly for SUD screening. Primary Funding Source: National Institute on Drug Abuse.Item Open Access Pharmacy-based methadone treatment in the US: views of pharmacists and opioid treatment program staff.(Substance abuse treatment, prevention, and policy, 2023-09) Wu, Li-Tzy; Mannelli, Paolo; John, William S; Anderson, Alyssa; Schwartz, Robert PBackground
The US federal regulations allow pharmacy administration and dispensing of methadone for opioid use disorder (PADMOUD) to increase the capability of opioid treatment programs (OTPs) in providing methadone maintenance treatment (MMT) for opioid use disorder (OUD) as part of a medication unit. However, there is a lack of research data from both pharmacy and OTP staff to inform the implementation of PADMOUD.Methods
Staff of a pharmacy (n = 8) and an OTP (n = 9) that participated in the first completed US trial on PADMOUD through electronic prescribing for methadone (parent study) were recruited to participate in this qualitative interview study to explore implementation-related factors for PADMOUD. Each interview was recorded and transcribed verbatim. NVivo was used to help identify themes of qualitative interview data. The Promoting Action on Research Implementation in Health Services (PARIHS) framework was used to guide the coding and interpretation of data.Results
Six pharmacy staff and eight OTP staff (n = 14) completed the interview. Results based on PARIHS domains were summarized, including evidence, context, and facilitation domains. Participants perceived benefits of PADMOUD for patients, pharmacies, OTPs, and payers. PADMOUD was considered to increase access for stable patients, provide additional patient service opportunities and revenues for pharmacies/pharmacists, enhance the capability of OTPs to treat more new patients, and reduce patients' cost when receiving medication at a pharmacy relative to an OTP. Both pharmacy and OTP staff were perceived to be supportive of the implementation of PADMOUD. Pharmacy staff/pharmacists were perceived to need proper training on addiction and methadone as well as a protocol of PADMOUD to conduct PADMOUD. Facilitators include having thought leaders to guide the operation, a certification program to ensure proper training of pharmacy staff/pharmacist, having updated pharmacy service software or technology to streamline the workflow of delivering PADMOUD and inventory management, and reimbursement for pharmacists.Conclusion
This study presents the first findings on perspectives of PADMOUD from both staff of a community pharmacy and an OTP in the US. Finding on barriers and facilitators are useful data to guide the development of strategies to implement PADMOUD to help address the US opioid crisis.Item Open Access Prevalence and patterns of opioid misuse and opioid use disorder among primary care patients who use tobacco.(Drug and alcohol dependence, 2019-01) John, William S; Zhu, He; Mannelli, Paolo; Subramaniam, Geetha A; Schwartz, Robert P; McNeely, Jennifer; Wu, Li-TzyBACKGROUND: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. METHODS:Data were derived from a sample of 2000 adult (aged ≥18) primary care patients across 5 distinct clinics. Among past-year tobacco users (n = 882), we assessed the prevalence of opioid misuse and OUD by sociodemographic characteristics and past-year polysubstance use. 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: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 14.0% 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 (78.0%), a tobacco-cannabis use 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.Item Open Access Prevalence, patterns, and correlates of multiple substance use disorders among adult primary care patients.(Drug and alcohol dependence, 2018-06) John, William S; Zhu, He; Mannelli, Paolo; Schwartz, Robert P; Subramaniam, Geetha A; Wu, Li-TzyBACKGROUND: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. METHODS:Data were analyzed from a sample of 2000 adult (aged ≥ 18) primary care patients recruited for a multisite National Drug Abuse Treatment 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. RESULTS:Multiple SUDs were found among the majority of participants 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 (12.0%) 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 primary care physicians should be aware of multiple SUDs when planning treatment, especially among adults who are male, younger, less educated, or unemployed. Interventions that target multiple SUDs warrant future investigation.Item Open Access Proceedings of the 13th annual conference of INEBRIA.(Addiction science & clinical practice, 2016-09) Watson, Rod; Morris, James; Isitt, John; Barrio, Pablo; Ortega, Lluisa; Gual, Antoni; Conner, Kenneth; Stecker, Tracy; Maisto, Stephen; Paroz, Sophie; Graap, Caroline; Grazioli, Véronique S; Daeppen, Jean-Bernard; Collins, Susan E; Bertholet, Nicolas; McNeely, Jennifer; Kushnir, Vlad; Cunningham, John A; Crombie, Iain K; Cunningham, Kathryn B; Irvine, Linda; Williams, Brian; Sniehotta, Falko F; Norrie, John; Melson, Ambrose; Jones, Claire; Briggs, Andrew; Rice, Peter; Achison, Marcus; McKenzie, Andrew; Dimova, Elena; Slane, Peter W; Grazioli, Véronique S; Collins, Susan E; Paroz, Sophie; Graap, Caroline; Daeppen, Jean-Bernard; Baggio, Stéphanie; Dupuis, Marc; Studer, Joseph; Gmel, Gerhard; Magill, Molly; Grazioli, Véronique S; Tait, Robert J; Teoh, Lucinda; Kelty, Erin; Geelhoed, Elizabeth; Mountain, David; Hulse, Gary K; Renko, Elina; Mitchell, Shannon G; Lounsbury, David; Li, Zhi; Schwartz, Robert P; Gryczynski, Jan; Kirk, Arethusa S; Oros, Marla; Hosler, Colleen; Dusek, Kristi; Brown, Barry S; Finnell, Deborah S; Holloway, Aisha; Wu, Li-Tzy; Subramaniam, Geetha; Sharma, Gaurav; Wallhed Finn, Sara; Andreasson, Sven; Dvorak, Robert D; Kramer, Matthew P; Stevenson, Brittany L; Sargent, Emily M; Kilwein, Tess M; Harris, Sion K; Sherritt, Lon; Copelas, Sarah; Knight, John R; The Partnership for Adolescent Substance Use Research; Mdege, Noreen D; McCambridge, Jim; Bischof, Gallus; Bischof, Anja; Freyer-Adam, Jennis; Rumpf, Hans-Juergen; Fitzgerald, Niamh; Schölin, Lisa; Toner, Paul; Böhnke, Jan R; Veach, Laura J; Currin, Olivia; Dongre, Leigh Z; Miller, Preston R; White, Elizabeth; Williams, Emily C; Lapham, Gwen T; Bobb, Jennifer J; Rubinsky, Anna D; Catz, Sheryl L; Shortreed, Susan; Bensley, Kara M; Bradley, Katharine A; Milward, Joanna; Deluca, Paolo; Khadjesari, Zarnie; Watson, Rod; Fincham-Campbell, Stephanie; Drummond, Colin; Angus, Kathryn; Bauld, Linda; Baumann, Sophie; Haberecht, Katja; Schnuerer, Inga; Meyer, Christian; Rumpf, Hans-Jürgen; John, Ulrich; Gaertner, Beate; Barrault-Couchouron, Marion; Béracochéa, Marion; Allafort, Vincent; Barthélémy, Valérie; Bonnefoi, Hervé; Bussières, Emmanuel; Garguil, Véronique; Auriacombe, Marc; Saint-Jacques, Marianne; Dorval, Michel; M’Bailara, Katia; Segura-Garcia, Lidia; Ibañez-Martinez, Nuria; Mendive-Arbeloa, Juan Manuel; Anoro-Perminger, Manel; Diaz-Gallego, Pako; Piñar-Mateos, Mª Angeles; Colom-Farran, Joan; Deligianni, Marianthi; Yersin, Bertrand; Adam, Angeline; Weisner, Constance; Chi, Felicia; Lu, Wendy; Sterling, Stacy; Kraemer, Kevin L; McGinnis, Kathleen A; Fiellin, David A; Skanderson, Melissa; Gordon, Adam J; Robbins, Jonathan; Zickmund, Susan; Korthuis, P Todd; Edelman, E Jennifer; Hansen, Nathan B; Cutter, Christopher J; Dziura, James; Fiellin, Lynn E; O’Connor, Patrick G; Maisto, Stephen A; Bedimo, Roger; Gilbert, Cynthia; Marconi, Vincent C; Rimland, David; Rodriguez-Barradas, Maria; Simberkoff, Michael; Justice, Amy C; Bryant, Kendall J; Berman, Anne H; Shorter, Gillian W; Bray, Jeremy W; Barbosa, Carolina; Johansson, Magnus; Hester, Reid; Campbell, William; Souza Formigoni, Maria Lucia O; Andrade, André Luzi Monezi; Sartes, Laisa Marcorela Andreoli; Sundström, Christopher; Eék, Niels; Kraepelien, Martin; Kaldo, Viktor; Fahlke, Claudia; Hernandez, Lynn; Becker, Sara J; Jones, Richard N; Graves, Hannah R; Spirito, Anthony; Diestelkamp, Silke; Wartberg, Lutz; Arnaud, Nicolas; Thomasius, Rainer; Gaume, Jacques; Grazioli, Véronique; Fortini, Cristiana; Malan, Zelra; Mash, Bob; Everett-Murphy, Katherine; Grazioli, Véronique S; Studer, Joseph; Mohler-Kuo, M; Bertholet, Nicolas; Gmel, Gerhard; Doi, Lawrence; Cheyne, Helen; Jepson, Ruth; Luna, Vanesa; Echeverria, Leticia; Morales, Silvia; Barroso, Teresa; Abreu, Ângela; Aguiar, Cosma; Stewart, Duncan; Abreu, Angela; Brites, Riany M; Jomar, Rafael; Marinho, Gerson; Parreira, Pedro; Seale, J Paul; Johnson, J Aaron; Henry, Dena; Chalmers, Sharon; Payne, Freida; Tuck, Linda; Morris, Akula; Gonçalves, Cátia; Besser, Bettina; Casajuana, Cristina; López-Pelayo, Hugo; Balcells, María Mercedes; Teixidó, Lídia; Miquel, Laia; Colom, Joan; Hepner, Kimberly A; Hoggatt, Katherine J; Bogart, Andy; Paddock, Susan M; Hardoon, Sarah L; Petersen, Irene; Hamilton, Fiona L; Nazareth, Irwin; White, Ian R; Marston, Louise; Wallace, Paul; Godfrey, Christine; Murray, Elizabeth; Sovinová, Hana; Csémy, LadislavItem Open Access Reference periods in retrospective behavioral self-report: A qualitative investigation.(The American journal on addictions, 2015-12) Gryczynski, Jan; Nordeck, Courtney; Mitchell, Shannon Gwin; O'Grady, Kevin E; McNeely, Jennifer; Wu, Li-Tzy; Schwartz, Robert PSelf-report questions in substance use research and clinical screening often ask individuals to reflect on behaviors, symptoms, or events over a specified time period. However, there are different ways of phrasing conceptually similar time frames (eg, past year vs. past 12 months).We conducted focused, abbreviated cognitive interviews with a sample of community health center patients (N = 50) to learn how they perceived and interpreted questions with alternative phrasing of similar time frames (past year vs. past 12 months; past month vs. past 30 days; past week vs. past 7 days).Most participants perceived the alternative time frames as identical. However, 28% suggested that the "past year" and "past 12 months" phrasings would elicit different responses by evoking distinct time periods and/or calling for different levels of recall precision. Different start and end dates for "past year" and "past 12 months" were reported by 20% of the sample. There were fewer discrepancies for shorter time frames.Use of "past 12 months" rather than "past year" as a time frame in self-report questions could yield more precise responses for a substantial minority of adult respondents.Subtle differences in wording of conceptually similar time frames can affect the interpretation of self-report questions and the precision of responses.Item Open Access Research priorities for expanding access to methadone treatment for opioid use disorder in the United States: A National Institute on Drug Abuse Center for Clinical Trials Network Task Force report.(Substance abuse, 2021-01) Joudrey, Paul J; Bart, Gavin; Brooner, Robert K; Brown, Lawrence; Dickson-Gomez, Julie; Gordon, Adam; Kawasaki, Sarah S; Liebschutz, Jane M; Nunes, Edward; McCarty, Dennis; Schwartz, Robert P; Szapocnik, José; Trivedi, Madhukar; Tsui, Judith I; Williams, Arthur; Wu, Li-Tzy; Fiellin, David AIn the US, methadone treatment can only be provided to patients with opioid use disorder (OUD) through federal and state-regulated opioid treatment programs (OTPs). There is a shortage of OTPs, and racial and geographic inequities exist in access to methadone treatment. The National Institute on Drug Abuse Center for Clinical Trials Network convened the Methadone Access Research Task Force to develop a research agenda to expand and create more equitable access to methadone treatment for OUD. This research agenda included mechanisms that are available within and outside the current regulations. The task force identified 6 areas where research is needed: (1) access to methadone in general medical and other outpatient settings; (2) the impact of methadone treatment setting on patient outcomes; (3) impact of treatment structure on outcomes in patients receiving methadone; (4) comparative effectiveness of different medications to treat OUD; (5) optimal educational and support structure for provision of methadone by medical providers; and (6) benefits and harms of expanded methadone access. In addition to outlining these research priorities, the task force identified important cross-cutting issues, including the impact of patient characteristics, treatment, and treatment system characteristics such as methadone formulation and dose, concurrent behavioral treatment, frequency of dispensing, urine or oral fluid testing, and methods of measuring clinical outcomes. Together, the research priorities and cross-cutting issues represent a compelling research agenda to expand access to methadone in the US.Item Open Access The Opioid Use Disorder Core Outcomes Set (OUD-COS) for treatment research: findings from a Delphi consensus study.(Addiction (Abingdon, England), 2022-03-16) Karnik, Niranjan S; Marsden, John; McCluskey, Connor; Boley, Randy A; Bradley, Katharine A; Campbell, Cynthia I; Curtis, Megan E; Fiellin, David; Ghitza, Udi; Hefner, Kathryn; Hser, Yih-Ing; McHugh, R Kathryn; McPherson, Sterling M; Mooney, Larissa J; Moran, Landhing M; Murphy, Sean M; Schwartz, Robert P; Shmueli-Blumberg, Dikla; Shulman, Matisyahu; Stephens, Kari A; Watkins, Katherine E; Weiss, Roger D; Wu, Li-TzyBackground and aim
There is no gold-standard and considerable heterogeneity in outcome measures used to evaluate treatments for opioid use disorder (OUD) along the opioid treatment cascade. The aim of this study was to develop the US National Institute on Drug Abuse (NIDA) National Drug Abuse Treatment Clinical Trials Network (CTN) opioid use disorder core outcomes set (OUD-COS).Design
Four round, e-Delphi expert panel consensus study and plenary research group discussion and targeted consultation.Setting
USA.Participants
A panel of 25 members including clinical practitioners, clinical researchers, and administrative staff from the CTN, the network's affiliated clinical and community sites, and the NIDA Centre for the CTN.Measurements
From a pool of 24 candidate items in four domains (biomedical/disease status; behaviors, symptoms, and functioning; opioid treatment cascade; and morbidity and mortality), the panel completed an online questionnaire to rank items with defined specification, on a 9-point scale for importance, with a standard 70% consensus criterion.Findings
After the fourth round of the questionnaire and subsequent discussion, consensus was reached for five outcomes: two patient reported (global impression of improvement and incident non-fatal overdose); one clinician reported (illicit/non-medical drug toxicology); and two from administrative records (duration of treatment and fatal opioid poisoning).Conclusions
An e-Delphi consensus study has produced the US National Institute on Drug Abuse (NIDA) National Drug Abuse Treatment Clinical Trials Network opioid use disorder core outcomes set (version 1) for opioid use disorder treatment efficacy and effectiveness research.Item Open Access Validation of the TAPS-1: A Four-Item Screening Tool to Identify Unhealthy Substance Use in Primary Care.(Journal of general internal medicine, 2017-09) Gryczynski, Jan; McNeely, Jennifer; Wu, Li-Tzy; Subramaniam, Geetha A; Svikis, Dace S; Cathers, Lauretta A; Sharma, Gaurav; King, Jacqueline; Jelstrom, Eve; Nordeck, Courtney D; Sharma, Anjalee; Mitchell, Shannon G; O'Grady, Kevin E; Schwartz, Robert PBACKGROUND: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. OBJECTIVE:To validate the TAPS-1 in primary care patients. DESIGN:Participants 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 three severity levels (problem use, mild SUD, and moderate-to-severe SUD). PARTICIPANTS:Two thousand adult patients at five primary care sites. MAIN MEASURES:DSM-5 SUD criteria were determined via the modified Composite International Diagnostic Interview. Oral fluid was used as a biomarker of recent drug use. KEY RESULTS:Optimal frequency-of-use cut-points on the self-administered TAPS-1 for identifying SUDs were ≥ 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:The TAPS-1 can identify unhealthy substance use in primary care patients with a high level of accuracy, and may have utility in primary care for rapid triage.