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Abstract Depression and anxiety frequently co-occur with opioid use disorder (OUD) yet are often overlooked in standard OUD treatments. This study evaluated the feasibility, acceptability, and preliminary effectiveness of a mobile application designed to address these symptoms in individuals receiving medications for OUD (MOUD). A randomized controlled trial recruited N = 63 adults with OUD who received MOUD and screened positive for moderate depression or generalized anxiety. Participants were randomized to an app-based digital intervention or treatment-as-usual for 4 weeks, and completed follow-ups at 4 and 8 weeks. Primary outcomes were self-reported severity measures for depression and generalized anxiety, and urine drug screens (UDS). Secondary outcomes included self-reported OUD severity, craving intensity, and digital biomarkers derived from passive smartphone sensors. The application was well-received (median app rating = 4/5 stars). The intervention group showed significant reductions in depressive and generalized anxiety symptoms post-intervention and at 8 weeks follow-up (d > 0.70), with large (d = 0.78) and moderate (d = 0.38) effect sizes, respectively, compared to controls. Both groups exhibited substantial decreases in self-reported severity of opioid use symptoms (d > 2.50). UDS suggested similar between-group adherence to MOUD, with a marginal decrease in opioid (MOP) use in the intervention group and increase in controls, yielding medium between group effect sizes (d = 0.44). Passive sensor data suggested significant increases in social connectedness in the intervention group, evidenced by a significant rise in incoming and outgoing calls and text connections. Initial evidence supports the feasibility and acceptability of a digital intervention for treating anxiety and depressive symptoms in persons receiving MOUD. While underpowered to confidently determine statistical significance beyond directionality, the intervention showed promise in reducing depressive and anxiety symptoms, suggesting its potential as a cost-effective and scalable adjunctive therapy alongside standard OUD treatment. Due to the preliminary nature of this pilot study, further research with sample sizes permitting greater statistical power is needed to confirm findings and explore long-term effects.

Abstract We describe the following shared data from N = 103 healthy adults who completed a broad set of cognitive tasks, surveys, and neuroimaging measurements to examine the construct of self-regulation. The neuroimaging acquisition involved task-based fMRI, resting state fMRI, and structural MRI. Each subject completed the following ten tasks in the scanner across two 90-minute scanning sessions: attention network test (ANT), cued task switching, Columbia card task, dot pattern expectancy (DPX), delay discounting, simple and motor selective stop signal, Stroop, a towers task, and a set of survey questions. The dataset is shared openly through the OpenNeuro project, and the dataset is formatted according to the Brain Imaging Data Structure (BIDS) standard.

Abstract Background Pharmacists remain an underutilized resource in the treatment of opioid use disorder (OUD). Although studies have engaged pharmacists in dispensing medications for OUD (MOUD), few studies have evaluated collaborative care models in which pharmacists are an active, integrated part of a primary care team offering OUD care. Methods This study seeks to implement a pharmacist integrated MOUD clinical model (called PrIMO) and evaluate its feasibility, acceptability, and impact across four diverse primary care sites. The Consolidated Framework for Implementation Research is used as an organizing framework for study development and interpretation of findings. Implementation Facilitation is used to support PrIMO adoption. We assess the primary outcome, the feasibility of implementing PrIMO, using the Stages of Implementation Completion (SIC). We evaluate the acceptability and impact of the PrIMO model at the sites using mixed-methods and combine survey and interview data from providers, pharmacists, pharmacy technicians, administrators, and patients receiving MOUD at the primary care sites with patient electronic health record data. We hypothesize that it is feasible to launch delivery of the PrIMO model (reach SIC Stage 6), and that it is acceptable, will positively impact patient outcomes 1 year post model launch (e.g., increased MOUD treatment retention, medication regimen adherence, service utilization for co-morbid conditions, and decreased substance use), and will increase each site’s capacity to care for patients with MOUD (e.g., increased number of patients, number of prescribers, and rate of patients per prescriber). Discussion This study will provide data on a pharmacist-integrated collaborative model of care for the treatment of OUD that may be feasible, acceptable to both site staff and patients and may favorably impact patients’ access to MOUD and treatment outcomes. Trial registration: The study was registered on Clinicaltrials.gov (NCT05310786) on April 5, 2022, https://www.clinicaltrials.gov/study/NCT05310786?id=NCT05310786&rank=1

Abstract Background National opioid-related overdose fatalities totaled 650,000 from 1999 to 2021. Some of the highest rates occurred in New Hampshire, where 40% of the population lives rurally. Medications for opioid use disorder (MOUD; methadone, buprenorphine, and naltrexone) have demonstrated effectiveness in reducing opioid overdose and mortality. Methadone access barriers disproportionally impact rural areas and naltrexone uptake has been limited. Buprenorphine availability has increased and relaxed regulations reduces barriers in general medical settings common in rural areas. Barriers to prescribing buprenorphine include lack of confidence, inadequate training, and lack of access to experts. To address these barriers, learning collaboratives have trained clinics on best-practice performance data collection to inform quality improvement (QI). This project sought to explore the feasibility of training clinics to collect performance data and initiate QI alongside clinics’ participation in a Project ECHO virtual collaborative for buprenorphine providers. Methods Eighteen New Hampshire clinics participating in a Project ECHO were offered a supplemental project exploring the feasibility of performance data collection to inform QI targeting increased alignment with best practice. Feasibility was assessed descriptively, through each clinic’s participation in training sessions, data collection, and QI initiatives. An end-of-project survey was conducted to understand clinic staff perceptions of how useful and acceptable they found the program. Results Five of the eighteen health care clinics that participated in the Project ECHO joined the training project, four of which served rural communities in New Hampshire. All five clinics met the criteria for engagement, as each clinic attended at least one training session, submitted at least one month of performance data, and completed at least one QI initiative. Survey results showed that while clinic staff perceived the training and data collection to be useful, there were several barriers to collecting the data, including lack of staff time, and difficulty standardizing documentation within the clinic electronic health record. Conclusions Results suggest that training clinics to monitor their performance and base QI initiatives on data has potential to impact clinical best practice. While data collection was inconsistent, clinics completed several data-informed QI initiatives, indicating that smaller scale data collection might be more attainable.

Abstract While the COVID-19 pandemic disrupted healthcare delivery everywhere, persons with carceral system involvement and opioid use disorder (OUD) were disproportionately impacted and vulnerable to severe COVID-associated illness. Carceral settings and community treatment programs (CTPs) rapidly developed protocols to sustain healthcare delivery while reducing risk of COVID-19 transmission. This survey study assessed changes to OUD treatment, telemedicine use, and re-entry support services among carceral and CTPs participating in the National Institute on Drug Abuse (NIDA)-funded study, Long-Acting Buprenorphine vs. Naltrexone Opioid Treatments in Criminal Justice System-Involved Adults (EXIT-CJS) study. In December 2020, carceral sites (n = 6; median pre-COVID 2020 monthly census = 3468 people) and CTPs (n = 7; median pre-COVID 2020 monthly census = 550 patients) participating in EXIT-CJS completed a cross-sectional web-based survey. The survey assessed changes pre- (January–March 2020) and post- (April–September 2020) COVID-19 in OUD treatment, telemedicine use, re-entry supports and referral practices. Compared to January–March 2020, half of carceral sites (n = 3) increased the total number of persons initiating medication for opioid use disorder (MOUD) from April–September 2020, while a third (n = 2) decreased the number of persons initiated. Most CTPs (n = 4) reported a decrease in the number of new admissions from April–September 2020, with two programs stopping or pausing MOUD programs due to COVID-19. All carceral sites with pre-COVID telemedicine use (n = 5) increased or maintained telemedicine use, and all CTPs providing MOUD (n = 6) increased telemedicine use. While expansion of telemedicine services supported MOUD service delivery, the majority of sites experienced challenges providing community support post-release, including referrals to housing, employment, and transportation services. During the COVID-19 pandemic, this small sample of carceral and CTP sites innovated to continue delivery of treatment for OUD. Expansion of telemedicine services was critical to support MOUD service delivery. Despite these innovations, sites experienced challenges providing reintegration supports for persons in the community. Pre-COVID strategies for identifying and engaging individuals while incarcerated may be less effective since the pandemic. In addition to expanding research on the most effective telemedicine practices for carceral settings, research exploring strategies to expand housing and employment support during reintegration are critical.

Abstract Background Existing implementation measures developed in high-income countries may have limited appropriateness for use within low- and middle-income countries (LMIC). In response, researchers at Johns Hopkins University began developing the Mental Health Implementation Science Tools (mhIST) in 2013 to assess priority implementation determinants and outcomes across four key stakeholder groups—consumers, providers, organization leaders, and policy makers—with dedicated versions of scales for each group. These were field tested and refined in several contexts, and criterion validity was established in Ukraine. The Consumer and Provider mhIST have since grown in popularity in mental health research, outpacing psychometric evaluation. Our objective was to establish the cross-context psychometric properties of these versions and inform future revisions. Methods We compiled secondary data from seven studies across six LMIC—Colombia, Myanmar, Pakistan, Thailand, Ukraine, and Zambia—to evaluate the psychometric performance of the Consumer and Provider mhIST. We used exploratory factor analysis to identify dimensionality, factor structure, and item loadings for each scale within each stakeholder version. We also used alignment analysis (i.e., multi-group confirmatory factor analysis) to estimate measurement invariance and differential item functioning of the Consumer scales across the six countries. Results All but one scale within the Provider and Consumer versions had Cronbach’s alpha greater than 0.8. Exploratory factor analysis indicated most scales were multidimensional, with factors generally aligning with a priori subscales for the Provider version; the Consumer version has no predefined subscales. Alignment analysis of the Consumer mhIST indicated a range of measurement invariance for scales across settings (R 2 0.46 to 0.77). Several items were identified for potential revision due to participant nonresponse or low or cross- factor loadings. We found only one item, which asked consumers whether their intervention provider was available when needed, to have differential item functioning in both intercept and loading. Conclusion We provide evidence that the Consumer and Provider versions of the mhIST are internally valid and reliable across diverse contexts and stakeholder groups for mental health research in LMIC. We recommend the instrument be revised based on these analyses and future research examine instrument utility by linking measurement to other outcomes of interest.

IntroductionThe COVID-19 pandemic has had an impact both in general and mental healthcare, challenged the health systems worldwide, and affected their capacity to deliver essential health services. We aimed to describe perceived changes in ease of access to general and mental healthcare among patients with a diagnosis of depression and/or unhealthy alcohol use in Colombia.MethodsThis study is embedded in the DIADA project, a multicenter implementation research study aimed at evaluating the integration of mental healthcare in primary care in Colombia. Between November 2020 and August 2021, we conducted a COVID-19 pandemic impact assessment in a cohort of participants with newly diagnosed depression and/or unhealthy alcohol use part of DIADA project. We assessed the ease of access and factors related to perceived ease of access to general or mental healthcare, during the COVID-19 pandemic.Results836 participants completed the COVID-19 pandemic impact assessment. About 30% of participants considered their mental health to be worse during the pandemic and 84.3% perceived access to general healthcare to be worse during the pandemic. Most of participants (85.8%) were unable to assess access to mental health services, but a significant proportion considered it to be worse. Experiencing worse ease of access to general healthcare was more frequent among women, patients with diagnosis of depression, and patients with comorbidities. Experiencing worse ease of access to mental healthcare was more frequent among patients aged between 30 and 49.9 years, from socioeconomic status between 4 and 6, affiliated to the contributive social security regime, attending urban study sites, and those who perceived their mental health was worse during the pandemic.DiscussionDespite the overall perception of worse mental health during the pandemic, the use of mental healthcare was low compared to general healthcare. Ease of access was perceived to be worse compared to pre-pandemic. Ease of access and access were affected by geographical study site, socioeconomic status, age and gender. Our findings highlight the need for improved communication between patients and institutions, tailored strategies to adapt the healthcare provision to patients' characteristics, and continued efforts to strengthen the role of mental healthcare provision in primary care.

Background: Increasing buprenorphine/naloxone (B/N) access for opioid use disorder (OUD) is essential yet ensuring adherence and preventing diversion remains challenging. This study examines the feasibility, usability, and acceptability of MySafeRx, a mobile platform integrating motivational coaching, adherence monitoring, and electronic dispensing during office-based B/N treatment. Methods: In this multi-site randomized controlled trial, MySafeRx provided coaching and supervised self-administration of B/N by mobile recovery coaches (MRCs) via videoconference. Referred adults (ages 18–65) with OUD were randomized to 1) 42-days of adjunctive MySafeRx treatment (n = 13) or 2) a standard care control group (n = 14). Results: The randomized sample was 63% female and 100% White. Twelve of 13 MySafeRx participants completed at least one MRC session. The mean system usability score reported by MySafeRx participants was 78.4 (n = 12). Participants indicated they would recommend MySafeRx to a friend (mean= 4.1 of 5), and that the dispenser (4.1 of 5) and videoconferencing (4.2 of 5) were easy to use. The MRC component had the highest acceptability (4.4 of 5). MRCs observed B/N self-administration for an average of 64.3% of the required study days (men: 68.9%; women: 57.9%). On average, men (n = 4) met with MRCs on 32±14 days versus 47±6 days for women (n = 8). Exploratory analyses did not show significant differences between intervention and control groups. Conclusions: Despite the small sample, this study supports usability and acceptability of MySafeRx. Increased adherence monitoring, even with remote coaching had limited appeal, which impacted feasibility due to slow recruitment, especially as community prescribing with relaxed monitoring requirements became more widespread.

Abstract Telemedicine (TM) enabled by digital health technologies to provide medical services has been considered a key solution to increasing health care access in rural communities. With the immediate need for remote care due to the COVID-19 pandemic, many health care systems have rapidly incorporated digital technologies to support the delivery of remote care options, including medication treatment for individuals with opioid use disorder (OUD). In responding to the opioid crisis and the COVID-19 pandemic, public health officials and scientific communities strongly support and advocate for greater use of TM-based medication treatment for opioid use disorder (MOUD) to improve access to care and have suggested that broad use of TM during the pandemic should be sustained. Nevertheless, research on the implementation and effectiveness of TM-based MOUD has been limited. To address this knowledge gap, the National Drug Abuse Treatment Clinical Trials Network (CTN) funded (via the NIH HEAL Initiative) a study on Rural Expansion of Medication Treatment for Opioid Use Disorder (Rural MOUD; CTN-0102) to investigate the implementation and effectiveness of adding TM-based MOUD to rural primary care for expanding access to MOUD. In preparation for this large-scale, randomized controlled trial incorporating TM in rural primary care, a feasibility study is being conducted to develop and pilot test implementation procedures. In this commentary, we share some of our experiences, which include several challenges, during the initial two-month period of the feasibility study phase. While these challenges could be due, at least in part, to adjusting to the COVID-19 pandemic and new workflows to accommodate the study, they are notable and could have a substantial impact on the larger, planned pragmatic trial and on TM-based MOUD more broadly. Challenges include low rates of identification of risk for OUD from screening, low rates of referral to TM, digital device and internet access issues, workflow and capacity barriers, and insurance coverage. These challenges also highlight the lack of empirical guidance for best TM practice and quality remote care models. With TM expanding rapidly, understanding implementation and demonstrating what TM approaches are effective are critical for ensuring the best care for persons with OUD.

Abstract Background For many reasons, the emergency department (ED) is a critical venue to initiate OUD interventions. The prevailing culture of the ED has been that substance use disorders are non-emergent conditions better addressed outside the ED where resources are less constrained. This study, its rapid funding mechanism, and accelerated timeline originated out of the urgent need to learn whether ED-initiated buprenorphine (BUP) with referral for treatment of OUD is generalizable, as well as to develop strategies to facilitate its adoption across a variety of ED settings and under real-world conditions. It both complements and uses methods adapted from Project ED Health (CTN-0069), a Hybrid Type 3 implementation-effectiveness study of using Implementation Facilitation (IF) to integrate ED-initiated BUP and referral programs. Methods ED-CONNECT (CTN 0079) was a three-site implementation study exploring the feasibility, acceptability, and impact of introducing ED-initiated BUP in rural and urban settings with high-need, limited resources, and different staffing structures. We used a multi-faceted approach to develop, introduce and iteratively refine site-specific ED clinical protocols and implementation plans for opioid use disorder (OUD) screening, ED-initiated BUP, and referral for treatment. We employed a participatory action research approach and use mixed methods incorporating data derived from abstraction of medical records and administrative data, assessments of recruited ED patient-participants, and both qualitative and quantitative inquiry involving staff from the ED and community, patients, and other stakeholders. Discussion This study was designed to provide the necessary, time-sensitive understanding of how to identify OUD and initiate treatment with BUP in the EDs previously not providing ED-initiated BUP, in communities in which this intervention is most needed: high need, low resource settings. Trial registration: The study was prospectively registered on ClinicalTrials.gov (NCT03544112) on June 01, 2018: https://clinicaltrials.gov/ct2/show/NCT03544112 .

Abstract Background Increasingly, treatment for opioid use disorder (OUD) is offered in integrated treatment models addressing both substance use and other health conditions within the same system. This often includes offering medications for OUD in general medical settings. It remains uncertain whether integrated OUD treatment models are preferred to non-integrated models, where treatment is provided within a distinct treatment system. This study aimed to explore preferences for integrated versus non-integrated treatment models among people with OUD and examine what factors may influence preferences. Methods This qualitative study recruited participants (n = 40) through Craigslist advertisements and flyers posted in treatment programs across the United States. Participants were 18 years of age or older and scored a two or higher on the heroin or opioid pain reliever sections of the Tobacco, Alcohol, Prescription Medications, and Other Substances (TAPS) Tool. Each participant completed a demographic survey and a telephone interview. The interviews were coded and content analyzed. Results While some participants preferred receiving OUD treatment from an integrated model in a general medical setting, the majority preferred non-integrated models. Some participants preferred integrated models in theory but expressed concerns about stigma and a lack of psychosocial services. Tradeoffs between integrated and non-integrated models were centered around patient values (desire for anonymity and personalization, fear of consequences), the characteristics of the provider and setting (convenience, perceived treatment effectiveness, access to services), and the patient-provider relationship (disclosure, trust, comfort, stigma). Conclusions Among this sample of primarily White adults, preferences for non-integrated versus integrated OUD treatment were mixed. Perceived benefits of integrated models included convenience, potential for treatment personalization, and opportunity to extend established relationships with medical providers. Recommendations to make integrated treatment more patient-centered include facilitating access to psychosocial services, educating patients on privacy, individualizing treatment, and prioritizing the patient-provider relationship. This sample included very few minorities and thus findings may not be fully generalizable to the larger population of persons with OUD. Nonetheless, results suggest a need for expansion of both OUD treatment in specialty and general medical settings to ensure access to preferred treatment for all.

IntroductionAcross the U.S., the prevalence of opioid use disorder (OUD) and the rates of opioid overdoses have risen precipitously in recent years. Several effective medications for OUD (MOUD) exist and have been shown to be life-saving. A large volume of research has identified a confluence of factors that predict attrition and continued substance use during substance use disorder treatment. However, much of this literature has examined a small set of potential moderators or mediators of outcomes in MOUD treatment and may lead to over-simplified accounts of treatment non-adherence. Digital health methodologies offer great promise for capturing intensive, longitudinal ecologically-valid data from individuals in MOUD treatment to extend our understanding of factors that impact treatment engagement and outcomes.MethodsThis paper describes the protocol (including the study design and methodological considerations) from a novel study supported by the National Drug Abuse Treatment Clinical Trials Network at the National Institute on Drug Abuse (NIDA). This study (D-TECT) primarily seeks to evaluate the feasibility of collecting ecological momentary assessment (EMA), smartphone and smartwatch sensor data, and social media data among patients in outpatient MOUD treatment. It secondarily seeks to examine the utility of EMA, digital sensing, and social media data (separately and compared to one another) in predicting MOUD treatment retention, opioid use events, and medication adherence [as captured in electronic health records (EHR) and EMA data]. To our knowledge, this is the first project to include all three sources of digitally derived data (EMA, digital sensing, and social media) in understanding the clinical trajectories of patients in MOUD treatment. These multiple data streams will allow us to understand the relative and combined utility of collecting digital data from these diverse data sources. The inclusion of EHR data allows us to focus on the utility of digital health data in predicting objectively measured clinical outcomes.DiscussionResults may be useful in elucidating novel relations between digital data sources and OUD treatment outcomes. It may also inform approaches to enhancing outcomes measurement in clinical trials by allowing for the assessment of dynamic interactions between individuals' daily lives and their MOUD treatment response.Clinical Trial RegistrationIdentifier: NCT04535583.

IntroductionSelf-regulation has been implicated in health risk behaviors and is a target of many health behavior interventions. Despite most prior research focusing on self-regulation as an individual-level trait, we hypothesize that self-regulation is a time-varying mechanism of health and risk behavior that may be influenced by momentary contexts to a substantial degree. Because most health behaviors (e.g., eating, drinking, smoking) occur in the context of everyday activities, digital technologies may help us better understand and influence these behaviors in real time. Using a momentary self-regulation measure, the current study (which was part of a larger multi-year research project on the science of behavior change) used ecological momentary assessment (EMA) to assess if self-regulation can be engaged and manipulated on a momentary basis in naturalistic, non-laboratory settings.MethodsThis one-arm, open-label exploratory study prospectively collected momentary data for 14 days from 104 participants who smoked regularly and 81 participants who were overweight and had binge-eating disorder. Four times per day, participants were queried about momentary self-regulation, emotional state, and social and environmental context; recent smoking and exposure to smoking cues (smoking sample only); and recent eating, binge eating, and exposure to binge-eating cues (binge-eating sample only). This study used a novel, momentary self-regulation measure comprised of four subscales: momentary perseverance, momentary sensation seeking, momentary self-judgment, and momentary mindfulness. Participants were also instructed to engage with Laddr, a mobile application that provides evidence-based health behavior change tools via an integrated platform. The association between momentary context and momentary self-regulation was explored via mixed-effects models. Exploratory assessments of whether recent Laddr use (defined as use within 12 h of momentary responses) modified the association between momentary context and momentary self-regulation were performed via mixed-effects models.ResultsParticipants (mean age 35.2; 78% female) in the smoking and binge-eating samples contributed a total of 3,233 and 3,481 momentary questionnaires, respectively. Momentary self-regulation subscales were associated with several momentary contexts, in the combined as well as smoking and binge-eating samples. For example, in the combined sample momentary perseverance was associated with location, positively associated with positive affect, and negatively associated with negative affect, stress, and tiredness. In the smoking sample, momentary perseverance was positively associated with momentary difficulty in accessing cigarettes, caffeine intake, and momentary restraint in smoking, and negatively associated with temptation and urge to smoke. In the binge-eating sample, momentary perseverance was positively associated with difficulty in accessing food and restraint in eating, and negatively associated with urge to binge eat. While recent Laddr use was not associated directly with momentary self-regulation subscales, it did modify several of the contextual associations, including challenging contexts.ConclusionsOverall, this study provides preliminary evidence that momentary self-regulation may vary in response to differing momentary contexts in samples from two exemplar populations with risk behaviors. In addition, the Laddr application may modify some of these relationships. These findings demonstrate the possibility of measuring momentary self-regulation in a trans-diagnostic way and assessing the effects of momentary, mobile interventions in context. Health behavior change interventions may consider measuring and targeting momentary self-regulation in addition to trait-level self-regulation to better understand and improve health risk behaviors. This work will be used to inform a later stage of research focused on assessing the transdiagnostic mediating effect of momentary self-regulation on medical regimen adherence and health outcomes.Clinical Trial RegistrationClinicalTrials.gov, Identifier: NCT03352713.

Abstract Objective Drug overdoses are the leading cause of death in the United States for those under 50 years of age, and New Hampshire has been disproportionately affected, resulting in increased encounters with the emergency response system. The ensuing impact on emergency personnel has received little attention. The present study aimed to explore the experiences and perspectives of emergency personnel responding to the opioid crisis in NH, with a focus on their views toward people who use opioids. Methods Thirty‐six emergency personnel (emergency department clinicians, n = 18; emergency medical service providers, n = 6; firefighters, n = 6; and police officers, n = 6) in 6 New Hampshire counties were interviewed about their experiences responding to overdoses and their perspectives on individuals who use opioids. Directed content analysis was used to identify themes in the transcribed, semistructured interviews. The results were reviewed for consensus. Results Several categories of themes were identified among emergency personnel's accounts of their overdose response experiences and perspectives, including varied degrees of compassion and stigma toward people who use opioids; associations between compassion or stigma and policy‐ and practice‐related themes, such as prehospital emergency care and the role of emergency departments (EDs); and primarily among personnel expressing compassion, a sense of professional responsibility that outweighed personal biases. Conclusions Despite the magnitude of the ongoing opioid crisis, some emergency personnel in New Hampshire have sustained or increased their compassion for people who use opioids. Others’ perspectives remain or have become increasingly stigmatizing. The associations of compassion and stigma with various policy‐ and practice‐related themes warrant further investigation.

As digital technology increasingly informs clinical trials, novel ways to collect study data in the natural field setting have the potential to enhance the richness of research data. Cocaine use in clinical trials is usually collected via self-report and/or urine drug screen results, both of which have limitations. This article examines the feasibility of developing a wrist-worn device that can detect sufficient physiological data (i.e., heart rate and heart rate variability) to detect cocaine use. This study aimed to develop a wrist-worn device that can be used in the natural field setting among people who use cocaine to collect reliable data (determined by data yield, device wearability, and data quality) that is less obtrusive than chest-based devices used in prior research. The study also aimed to further develop a cocaine use detection algorithm used in previous research with an electrocardiogram on a chestband by adapting it to a photoplethysmography sensor on the wrist-worn device which is more prone to motion artifacts. Results indicate that wrist-based heart rate data collection is feasible and can provide higher data yield than chest-based sensors, as wrist-based devices were also more comfortable and affected participants' daily lives less often than chest-based sensors. When properly worn, wrist-based sensors produced similar quality of heart rate and heart rate variability features to chest-based sensors and matched their performance in automated detection of cocaine use events.Clinical Trial Registration:www.ClinicalTrials.gov, identifier: NCT02915341.

Scientific progress relies on integrating and building on existing knowledge. Here, the authors propose improving cumulative science by developing data-driven ontologies, and they apply this approach to understanding the construct of self-regulation.

Abstract Background While buprenorphine/naloxone (B/N) is approved for opioid use disorder treatment, effective delivery of B/N comes with significant challenges. Most notably, many patients do not take medication daily as prescribed; this non-adherence worsens treatment outcomes, increases healthcare costs, and leads to persistent worries of diversion among providers and policymakers. The present study examines the feasibility, usability, and acceptability of MySafeRx—a mobile technology platform integrating motivational coaching, adherence monitoring, and electronic pill dispensing designed to address the challenges of office-based opioid treatment (OBOT) with B/N. Methods The MySafeRx platform integrates electronic pill dispensers, text-messaging, and videoconferencing to provide supervised self-administration of medication and daily motivational coaching through an Android app interface. High-risk early adults (18–39 years old) who were enrolled in OBOT with B/N and had documented illicit opioid use in the past month during opioid agonist therapy (n = 12) participated in a 28-day single-arm observational study of the MySafeRx platform in addition to standard care. Results Two-thirds of participants who completed the study achieved an average of > 5 days per week of supervised B/N self-administration. Visual confirmation of medication adherence was demonstrated for an average of 72% of study days among all participants. All participants achieved platform technical proficiency within 60 min, reporting good levels of usability and acceptability. Illicit opioid abstinence rates confirmed by urine toxicology increased by 53% during MySafeRx but fell 43% within 3 weeks post-intervention. Conclusion The MySafeRx medication adherence and remote coaching mobile platform is acceptable and can be feasibly implemented in real-world opioid use disorder treatment settings during high-risk periods (i.e., initial stabilization, after illicit opioid lapse), resulting in reduced illicit opioid use; however, the effect did not last after intervention completion, suggesting longer duration or extended taper of program may be needed. ClinicalTrials.Gov NCT02942199 10/24/16 https://clinicaltrials.gov/ct2/show/NCT02942199

ObjectiveTo assess the associations between dietary cognitive restraint, disinhibited eating, and how taste and health perceptions relate to food preference; and further, whether cognitive restraint and disinhibited eating are associated with food preference decision reaction time.MethodsFive hundred and seventeen adults participated in the study. Dietary cognitive restraint and disinhibited eating were assessed using the shortened Three-Factor Eating Questionnaire (TFEQ-R18). Participants also completed a dietary decision-making task to examine their food-related decisions. Participants were presented with 50 food items and asked to rate them for health and for taste. Participants were then presented with a reference food item and comparison items one at a time and asked to indicate which of the two foods they would prefer to eat.ResultsParticipants with higher levels of cognitive restraint were more sensitive to health perceptions whereas those with higher levels of disinhibited eating were more sensitive to taste perceptions when indicating food preference. Reaction time analysis corroborated these results. Being classified as high for cognitive restraint was associated with faster reaction times if the preferred food was rated as healthier than the referent food. Conversely, being classified as high for disinhibited eating was associated with faster reaction times if the preferred food was rated as tastier than the referent food.ConclusionThe dietary decision-making task appears to capture distinct aspects of dietary restraint and disinhibition and may be useful in future studies to measure and/or alter levels of dietary restraint and disinhibition.

Cocaine use in clinical trials is often measured via self-report, which can be inaccurate, or urine drug screens, which can be intrusive and burdensome. Devices that can automatically detect cocaine use and can be worn conveniently in daily life may provide several benefits. AutoSense is a wearable, physiological-monitoring suite that can detect cocaine use, but it may be limited as a method for monitoring cocaine use because it requires wearing a chestband with electrodes. This paper describes the design, rationale, and methodology of a project that seeks to build upon and extend previous work in the development of methods to detect cocaine use via wearable, unobtrusive mobile sensor technologies. To this end, a wrist-worn sensor suite (i.e., MotionSense HRV) will be developed and evaluated. Participants who use cocaine (N = 25) will be asked to wear MotionSense HRV and AutoSense for two weeks during waking hours. Drug use will be assessed via thrice-weekly urine drug screens and self-reports, and will be used to isolate periods of cocaine use that will be differentiated from other drug use. The present study will provide information on the feasibility and acceptability of using a wrist-worn device to detect cocaine use. Keywords: Cocaine, Device development, Mobile sensing, Methods or experimental design, Clinical trials network

The United States faces dramatically increasing rates of opioid overdose deaths, as well as persistent ongoing problems of undiagnosed HIV and HCV infection. These problems commonly occur together in substance using populations that have limited, if any, access to primary care and other routine health services. To collectively address all three issues, we developed the Mobile Intervention Kit (MIK), a tablet computer-based intervention designed to provide overdose prevention and response training and to facilitate HIV/HCV testing in community settings. Intervention content was produced in collaboration with experienced street outreach workers who appear onscreen in a series of educational videos. A preliminary pilot test of the MIK in a Bronx, NY street outreach syringe exchange program found the MIK is feasible and highly acceptable to a population of people who inject drugs. Participants accepted HIV and HCV testing post-intervention, as well as naloxone training to reverse overdose events. Pre-post tests also showed significant increases in knowledge of overdose prevention, HIV testing procedures, and asymptomatic HCV infection. Future iterations of the MIK can be optimized for use in community as well as clinical settings nationwide, and perhaps globally, with a focus on underserved urban populations.

Emergency departments (EDs) frequently serve people who have limited, if any, additional interactions with health care, yet many ED patients are not offered HIV testing, and those who are frequently decline. ED staff (n = 13) at a high volume urban ED (technicians, nurses, physicians, and administrators) were interviewed to elicit their perspectives on the feasibility and acceptability of a tablet-based intervention designed to increase HIV test rates among patients who initially decline testing. Content-based thematic analysis of semi-structured interviews indicated overall support for interventions to increase HIV testing, but a lack of available staff resources emerged as a potential barrier to widespread implementation. Also, some ED staff questioned whether it was appropriate to shift responsibility for public health services, such as HIV testing, to the ED instead of a primary care setting. Although tablet-based interventions have been shown effective in high volume ED settings and can potentially increase HIV test rates among hard-to-reach populations, additional effort is now required to better integrate this type of intervention into existing workflows.