This pattern highlighting the effectiveness of TES was evident across diverse groups of patients, including those with stimulant, cannabis and alcohol use disorders , those with and without criminal justice involvement those with and without Internet access , and across both males and females and diverse racial and ethnic groups . TES was also found to have promising cost-effectiveness . This CTN trial built on a prior body of NIDA-funded single site trials showing, for example, that adding TES to buprenorphine treatment produces synergistic treatment effects; that replacing part of counselor-delivered treatment with TES treatment in methadone treatment systems greatly improves patients’ treatment outcomes, and that TES offered to incarcerated individuals can produce comparable treatment outcomes to those produced by exclusively clinician-delivered care . By conducting a national, highly rigorous multi-site trial, the CTN study was well-poised to demonstrate the safety and effectiveness of the TES digital intervention when reviewed by the FDA, leading to the very first FDA-authorized prescription digital therapeutic in the U.S. . This reflects a new category of FDA-regulated devices and allows for digital therapeutics to be prescribed by clinicians, in a manner similar to FDA-approved medications. This is a compelling example of how CTN research can change the landscape of care to scale-up access to evidence-based treatments for SUDs. This work led to several ancillary CTN studies focused on enhancing TES to be modified for American Indians and Alaskan Natives . And, several mobile digital therapeutics will be included in a new national CTN trial that will test strategies to improve treatment retention in medication treatment for OUD and to improve outcomes among individuals who are stabilized on OUD medications but wish to discontinue such medications .
Although treatments for SUDs,cannabis grow room including OUD, have been shown to be life-saving , many communities across the nation are challenged by not having sufficient clinician capacity to conduct universal screening and medication induction and maintenance to the large population who may need it. This is particularly challenging in rural contexts which have lower capacity for evidence-based opioid treatment, including fewer waivered buprenorphine prescribers, behavioral health clinicians, and opioid treatment programs and often lack of a widespread public transportation system. To address this challenge, the CTN is launching a large multi-site trial to evaluate the effectiveness of a telehealth model of care for the medication treatment of OUD , designed to help ensure sufficient and sustainable capacity to offer evidence-based opioid treatment in rural communities . This cluster-randomized, comparative effectiveness trial will examine the utility of adding tele-MOUD to outpatient MOUD treatment compared to outpatient MOUD treatment alone in rural areas highly impacted by the U.S. opioid crisis. Tele-MOUD will flexibly offer patients remote access to a core team of OUD experts who can assess and prescribe medications to individuals with OUD, provide therapy, and/or provide remote urine and/or saliva drug testing. Another new primary care-based CTN trial , which seeks to identify an effective strategy to address unhealthy opioid use and prevent escalation to an opioid use disorder, will also offer remote telecounseling to participants to enhance onsite care centrally led by a nurse care manager. The collective learning from this research will inform innovative models that can scale access to a suite of evidence-based treatment for OUD in high need, low resource settings. The first of these studies developed and evaluated the ability of a wrist-worn sensor suite to detect cocaine use . This work builds on prior promising work demonstrating that a chest band with electrodes can detect cocaine use via a computational model that uses heart rate and physical activity data .
The present study seeks to evaluate whether similar cocaine detection algorithms will work, that have been modified for use with sensor data collected via a less obtrusive, more user-friendly smartwatch that can be worn in daily life. Data from the smartwatch is compared to chest band data as well as EMA reports of cocaine use of cocaine use. Cocaine use is often measured via self-report, which can be inaccurate, and/or use is measured via urine drug tests which can be intrusive and may not capture the temporal granularity of cocaine use patterns . If smartwatch sensing is determined to be an acceptable and accurate way to measure cocaine use, it may offer rich information about the precise timing and duration of use events and could allow us to glean new insights into contextual factors that may serve as triggers for use events. Additionally, detecting cocaine use with greater precision may enhance our outcomes measurement in clinical trials that evaluate potential therapeutics for cocaine use disorder. The second of these CTN studies is, to our knowledge, the first study to employ passive mobile sensing, social media data, and active responses to queries on mobile devices using EMA to obtain moment-by-moment quantification of individual-level data that may lead to opioid use events, medication non-adherence and/or MOUD treatment dropout/retention in a population of persons with OUD in buprenorphine treatment. In this study, participants are asked to wear a smartwatch and carry a smartphone continuously for a period of 12 weeks. The smartwatch passively collects data regarding location and distance traveled, physical activity , sleep, and heart rate. Participants are also prompted to respond to questions through a smartphone multiple times per day. Questions assess sleep, stress, pain severity, pain interference, pain catastrophizing, craving, withdrawal, substance use risk context, mood, location, substance use, self-regulation, and MOUD adherence. In addition to the EMA prompts, individuals are asked to self-initiate EMAs if substance use occurred.
App usage, audio/conversation, call/text, GPS, screen on/off, phone lock/unlock, phone notification information, Wi-Fi & Bluetooth logs, sleep, ambient light, and proximity are passively collected via smartphone. Participants are also asked if they are willing to share their social media data from any social media platforms they may use . Sharing social media data is an optional component of study participation. The primary objective of the study is to evaluate the feasibility of utilizing digital health technology with OUD patients as measured by a 12-week period of continuous assessment using EMA and digital sensing. A secondary objective of this study is to examine the utility of EMA, digital sensing, and social media data in predicting OUD treatment retention and buprenorphine medication adherence. Overall, this line of research may inform which subset of digitally-derived data may be most useful to employ as part of outcome measurement in future clinical trials research. Digital data that capture the richness of clinical status and clinically trajectories as individuals go about their daily lives may greatly complement and enhance the learning from standardized, clinical outcomes assessment. And predicting OUD treatment retention and medication adherence via continuous digital assessments may be used to identify early those participants who show signs of non-adherence and trigger additional intervention to prevent ultimate non-response to treatment. In addition to the CTN-0084-A2 study referenced above which includes social media data as part of a broader set of digitally-derived data, the CTN supports a trial that centrally evaluates the relative utility of various social media platforms in recruiting a national sample from a hard-to-reach population. Specifically, this trial compares the relative effectiveness of using social media sites vs. online informational sites vs. online dating sites to promote HIV self-testing and seamless linkage to pre-exposure prophylaxis medication among young , racial/ethnic minority,grow trays high-risk men who have sex with men . In this study, individuals in the targeted sample who click on culturally tailored study advertisements and who provide online consent will be offered a free HIV self-test kit to be discreetly sent to their home with seamless linkage to PrEP for those who test HIV-negative, and linkage to HIV care resources for those who test positive. Among other outcomes, the primary outcome is the monthly rate by promotional platform . The modifying role of substance use on observed outcomes will also be examined. Online recruitment strategies allow for targeted recruitment of select audiences. The CTN-0083 study will target recruitment in the states that have hard-to-reach, high risk populations and limited availability of risk reduction services . This study illustrates how a targeted national sample can be recruited for clinical trials participation and how all intervention delivery and data collection in a clinical trial can be conducted remotely online.
This manuscript provides an overview of the breadth and impact of research conducted within the U.S. National Drug Abuse Treatment Clinical Trials Network in the realm of digital health. This work has included the CTN’s efforts to systematically embed digital screeners for SUDs into general medical settings to increase the diagnosis and treatment of SUDs 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 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. The CTN has also supported the conduct of clinical trials entirely online . Further, the CTN is conducting innovative work focused on the use of digital health technologies and data analytics to identify digital biomarkers and understand the clinical trajectories of individuals with OUD in buprenorphine medication treatment for OUD. Given its unique national research infrastructure and access to a broad array of community and healthcare partners, the CTN is uniquely poised to accelerate the scope and impact of its work applying digital health to the assessment and treatment of SUDs. Among these opportunities, the CTN is positioned to evaluate the role of digital technologies in SUD care transitions. For example, offering persons with SUDs access to a digital therapeutic and/or telehealth when they transition from a period of incarceration, hospitalization, or inpatient SUD care to the community would provide them with 24/7 access to therapeutic support as they reintegrate into the community and/or community-based care. Digital tools may also be offered directly to individuals recruited online who are not engaged, and do not wish to engage in SUD care within the health care system. Given that only about 10% of persons with SUDs are engaged in treatment, there is tremendous opportunity to creatively use digital technology to provide the other 90% with evidence-based SUD resources . The CTN is optimally poised to conduct national implementation science trials and/or hybrid implementation-effectiveness trials to evaluate optimal strategies to implement and sustain digitally-enhanced models of care. Such trials could integrate the various digital health tools and approaches that the CTN has previously studied in separate studies to instead embed a suite of complementary digital tools spanning an entire model of care within an integrated implementation strategy. That is, a digitally-enhanced model of care could include digital screeners and assessments in medical settings, linkage to electronic clinical decision support tools to enhance providers’ ability to deliver state-of-the-science care, as well as provision of digital therapeutics that are available directly to patients to ensure evidence-based care is available to them anytime and anywhere and can complement the care they receive in the healthcare sector. Importantly, digital therapeutics offered to patients do not need to reflect static models of behavioral treatment that work exactly the same way with every end user. Rather, these tools can be adaptive and flexibly offer evidence-based therapeutic resources to individuals that are responsive to their changing clinical needs, preferences, and goals. There is tremendous opportunity to integrate the science of digital assessment and digital therapeutics for SUDs to help us understand when individuals may be most receptive to health promotion interventions. They can, in turn, inform optimal delivery of “Just-in-Time Adaptive Interventions” or in-the-moment interventions for SUDs that provide the right type/amount of therapeutic support at the right time . The large and diverse samples that can be recruited within the CTN offer many opportunities to conduct novel experimental approaches to systematically investigate who would benefit from which intervention and when , as well as to apply novel statistical machine learning methods to personalize SUD interventions at the individual level .