An Examination of the Feasibility of Detecting Cocaine Use Using Smartwatches.

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.

The mobile assistance for regulating smoking (MARS) micro-randomized trial design protocol.

Smoking is the leading preventable cause of death and disability in the U.S. Empirical evidence suggests that engaging in evidence-based self-regulatory strategies (e.g., behavioral substitution, mindful attention) can improve smokers' ability to resist craving and build self-regulatory skills. However, poor engagement represents a major barrier to maximizing the impact of self-regulatory strategies. This paper describes the protocol for Mobile Assistance for Regulating Smoking (MARS) - a research study designed to inform the development of a mobile health (mHealth) intervention for promoting real-time, real-world engagement in evidence-based self-regulatory strategies. The study will employ a 10-day Micro-Randomized Trial (MRT) enrolling 112 smokers attempting to quit. Utilizing a mobile smoking cessation app, the MRT will randomize each individual multiple times per day to either: (a) no intervention prompt; (b) a prompt recommending brief (low effort) cognitive and/or behavioral self-regulatory strategies; or (c) a prompt recommending more effortful cognitive or mindfulness-based strategies. Prompts will be delivered via push notifications from the MARS mobile app. The goal is to investigate whether, what type of, and under what conditions prompting the individual to engage in self-regulatory strategies increases engagement. The results will build the empirical foundation necessary to develop a mHealth intervention that effectively utilizes intensive longitudinal self-report and sensor-based assessments of emotions, context and other factors to engage an individual in the type of self-regulatory activity that would be most beneficial given their real-time, real-world circumstances. This type of mHealth intervention holds enormous potential to expand the reach and impact of smoking cessation treatments.

The Validity of MotionSense HRV in Estimating Sedentary Behavior and Physical Activity under Free-Living and Simulated Activity Settings.

MotionSense HRV is a wrist-worn accelerometery-based sensor that is paired with a smartphone and is thus capable of measuring the intensity, duration, and frequency of physical activity (PA). However, little information is available on the validity of the MotionSense HRV. Therefore, the purpose of this study was to assess the concurrent validity of the MotionSense HRV in estimating sedentary behavior (SED) and PA. A total of 20 healthy adults (age: 32.5 ± 15.1 years) wore the MotionSense HRV and ActiGraph GT9X accelerometer (GT9X) on their non-dominant wrist for seven consecutive days during free-living conditions. Raw acceleration data from the devices were summarized into average time (min/day) spent in SED and moderate-to-vigorous PA (MVPA). Additionally, using the Cosemed K5 indirect calorimetry system (K5) as a criterion measure, the validity of the MotionSense HRV was examined in simulated free-living conditions. Pearson correlations, mean absolute percent errors (MAPE), Bland-Altman (BA) plots, and equivalence tests were used to examine the validity of the MotionSense HRV against criterion measures. The correlations between the MotionSense HRV and GT9X were high and the MAPE were low for both the SED (r = 0.99, MAPE = 2.4%) and MVPA (r = 0.97, MAPE = 9.1%) estimates under free-living conditions. BA plots illustrated that there was no systematic bias between the MotionSense HRV and criterion measures. The estimates of SED and MVPA from the MotionSense HRV were significantly equivalent to those from the GT9X; the equivalence zones were set at 16.5% for SED and 29% for MVPA. The estimates of SED and PA from the MotionSense HRV were less comparable when compared with those from the K5. The MotionSense HRV yielded comparable estimates for SED and PA when compared with the GT9X accelerometer under free-living conditions. We confirmed the promising application of the MotionSense HRV for monitoring PA patterns for practical and research purposes.

Using novel mobile sensors to assess stress and smoking lapse.

Mobile sensors can now provide unobtrusive measurement of both stress and cigarette smoking behavior. We describe, here, the first field tests of two such methods, cStress and puffMarker, that were used to examine relationships between stress and smoking behavior and lapse from a sample of 76 smokers motivated to quit smoking. Participants wore a mobile sensors suite, called AutoSense, which collected continuous physiological data for 4 days (24-hours pre-quit and 72-hours post-quit) in the field. Algorithms were applied to the physiological data to create indices of stress (cStress) and first lapse smoking episodes (puffMarker). We used mixed effects interrupted autoregressive time series models to assess changes in heart rate (HR), cStress, and nicotine craving across the 4-day period. Self-report assessments using ecological momentary assessment (EMA) of mood, withdrawal symptoms, and smoking behavior were also used. Results indicated that HR and cStress, respectively, predicted smoking lapse. These results suggest that measures of traditional psychophysiology, such as HR, are not redundant with cStress; both provide important information. Results are consistent with existing literature and provide clear support for cStress and puffMarker in ambulatory clinical research. This research lays groundwork for sensor-based markers in developing and delivering sensor-triggered, just-in-time interventions that are sensitive to stress-related lapser risk factors.

The application of digital health to the assessment and treatment of substance use disorders: The past, current, and future role of the National Drug Abuse Treatment Clinical Trials Network.

The application of digital technologies to better assess, understand, and treat substance use disorders (SUDs) is a particularly promising and vibrant area of scientific research. The National Drug Abuse Treatment Clinical Trials Network (CTN), launched in 1999 by the U.S. National Institute on Drug Abuse, has supported a growing line of research that leverages digital technologies to glean new insights into SUDs and provide science-based therapeutic tools to a diverse array of persons with SUDs. This manuscript provides an overview of the breadth and impact of research conducted in the realm of digital health within the CTN. This work has included the CTN's efforts to systematically embed digital screeners for SUDs into general medical settings to impact care models across the nation. This work has also included a pivotal multi-site clinical trial conducted on the CTN platform, whose data led to the very first "prescription digital therapeutic" authorized by the U.S. Food and Drug Administration (FDA) for the treatment of SUDs. Further CTN research includes the study of telehealth to increase capacity for science-based SUD treatment in rural and under-resourced communities. In addition, the CTN has supported an assessment of the feasibility of detecting cocaine-taking behavior via smartwatch sensing. And, the CTN has supported the conduct of clinical trials entirely online (including the recruitment of national and hard-to-reach/under-served participant samples online, with remote intervention delivery and data collection). Further, the CTN is supporting innovative work focused on the use of digital health technologies and data analytics to identify digital biomarkers and understand the clinical trajectories of individuals receiving medications for opioid use disorder (OUD). This manuscript concludes by outlining the many potential future opportunities to leverage the unique national CTN research network to scale-up the science on digital health to examine optimal strategies to increase the reach of science-based SUD service delivery models both within and outside of healthcare.

SmokingOpp: Detecting the Smoking 'Opportunity' Context Using Mobile Sensors.

Context plays a key role in impulsive adverse behaviors such as fights, suicide attempts, binge-drinking, and smoking lapse. Several contexts dissuade such behaviors, but some may trigger adverse impulsive behaviors. We define these latter contexts as 'opportunity' contexts, as their passive detection from sensors can be used to deliver context-sensitive interventions. In this paper, we define the general concept of 'opportunity' contexts and apply it to the case of smoking cessation. We operationalize the smoking 'opportunity' context, using self-reported smoking allowance and cigarette availability. We show its clinical utility by establishing its association with smoking occurrences using Granger causality. Next, we mine several informative features from GPS traces, including the novel location context of smoking spots, to develop the SmokingOpp model for automatically detecting the smoking 'opportunity' context. Finally, we train and evaluate the SmokingOpp model using 15 million GPS points and 3,432 self-reports from 90 newly abstinent smokers in a smoking cessation study.

Towards detecting cocaine use using smartwatches in the NIDA clinical trials network: Design, rationale, and methodology.

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.

mCrave: Continuous Estimation of Craving During Smoking Cessation.

Craving usually precedes a lapse for impulsive behaviors such as overeating, drinking, smoking, and drug use. Passive estimation of craving from sensor data in the natural environment can be used to assist users in coping with craving. In this paper, we take the first steps towards developing a computational model to estimate cigarette craving (during smoking abstinence) at the minute-level using mobile sensor data. We use 2,012 hours of sensor data and 1,812 craving self-reports from 61 participants in a smoking cessation study. To estimate craving, we first obtain a continuous measure of stress from sensor data. We find that during hours of day when craving is high, stress associated with self-reported high craving is greater than stress associated with low craving. We use this and other insights to develop feature functions, and encode them as pattern detectors in a Conditional Random Field (CRF) based model to infer craving probabilities.

puffMarker: A Multi-Sensor Approach for Pinpointing the Timing of First Lapse in Smoking Cessation.

Recent researches have demonstrated the feasibility of detecting smoking from wearable sensors, but their performance on real-life smoking lapse detection is unknown. In this paper, we propose a new model and evaluate its performance on 61 newly abstinent smokers for detecting a first lapse. We use two wearable sensors - breathing pattern from respiration and arm movements from 6-axis inertial sensors worn on wrists. In 10-fold cross-validation on 40 hours of training data from 6 daily smokers, our model achieves a recall rate of 96.9%, for a false positive rate of 1.1%. When our model is applied to 3 days of post-quit data from 32 lapsers, it correctly pinpoints the timing of first lapse in 28 participants. Only 2 false episodes are detected on 20 abstinent days of these participants. When tested on 84 abstinent days from 28 abstainers, the false episode per day is limited to 1/6.

cStress: Towards a Gold Standard for Continuous Stress Assessment in the Mobile Environment.

Recent advances in mobile health have produced several new models for inferring stress from wearable sensors. But, the lack of a gold standard is a major hurdle in making clinical use of continuous stress measurements derived from wearable sensors. In this paper, we present a stress model (called cStress) that has been carefully developed with attention to every step of computational modeling including data collection, screening, cleaning, filtering, feature computation, normalization, and model training. More importantly, cStress was trained using data collected from a rigorous lab study with 21 participants and validated on two independently collected data sets - in a lab study on 26 participants and in a week-long field study with 20 participants. In testing, the model obtains a recall of 89% and a false positive rate of 5% on lab data. On field data, the model is able to predict each instantaneous self-report with an accuracy of 72%.

Center of excellence for mobile sensor data-to-knowledge (MD2K).

Mobile sensor data-to-knowledge (MD2K) was chosen as one of 11 Big Data Centers of Excellence by the National Institutes of Health, as part of its Big Data-to-Knowledge initiative. MD2K is developing innovative tools to streamline the collection, integration, management, visualization, analysis, and interpretation of health data generated by mobile and wearable sensors. The goal of the big data solutions being developed by MD2K is to reliably quantify physical, biological, behavioral, social, and environmental factors that contribute to health and disease risk. The research conducted by MD2K is targeted at improving health through early detection of adverse health events and by facilitating prevention. MD2K will make its tools, software, and training materials widely available and will also organize workshops and seminars to encourage their use by researchers and clinicians.

Continuous in-the-field measurement of heart rate: Correlates of drug use, craving, stress, and mood in polydrug users.

BACKGROUND: Ambulatory physiological monitoring could clarify antecedents and consequences of drug use and could contribute to a sensor-triggered mobile intervention that automatically detects behaviorally risky situations. Our goal was to show that such monitoring is feasible and can produce meaningful data. METHODS: We assessed heart rate (HR) with AutoSense, a suite of biosensors that wirelessly transmits data to a smartphone, for up to 4 weeks in 40 polydrug users in opioid-agonist maintenance as they went about their daily lives. Participants also self-reported drug use, mood, and activities on electronic diaries. We compared HR with self-report using multilevel modeling (SAS Proc Mixed). RESULTS: Compliance with AutoSense was good; the data yield from the wireless electrocardiographs was 85.7%. HR was higher when participants reported cocaine use than when they reported heroin use (F(2,9)=250.3, p<.0001) and was also higher as a function of the dose of cocaine reported (F(1,8)=207.7, p<.0001). HR was higher when participants reported craving heroin (F(1,16)=230.9, p<.0001) or cocaine (F(1,14)=157.2, p<.0001) than when they reported of not craving. HR was lower (p<.05) in randomly prompted entries in which participants reported feeling relaxed, feeling happy, or watching TV, and was higher when they reported feeling stressed, being hassled, or walking. CONCLUSIONS: High-yield, high-quality heart-rate data can be obtained from drug users in their natural environment as they go about their daily lives, and the resultant data robustly reflect episodes of cocaine and heroin use and other mental and behavioral events of interest.

Identifying Drug (Cocaine) Intake Events from Acute Physiological Response in the Presence of Free-living Physical Activity.

A variety of health and behavioral states can potentially be inferred from physiological measurements that can now be collected in the natural free-living environment. The major challenge, however, is to develop computational models for automated detection of health events that can work reliably in the natural field environment. In this paper, we develop a physiologically-informed model to automatically detect drug (cocaine) use events in the free-living environment of participants from their electrocardiogram (ECG) measurements. The key to reliably detecting drug use events in the field is to incorporate the knowledge of autonomic nervous system (ANS) behavior in the model development so as to decompose the activation effect of cocaine from the natural recovery behavior of the parasympathetic nervous system (after an episode of physical activity). We collect 89 days of data from 9 active drug users in two residential lab environments and 922 days of data from 42 active drug users in the field environment, for a total of 11,283 hours. We develop a model that tracks the natural recovery by the parasympathetic nervous system and then estimates the dampening caused to the recovery by the activation of the sympathetic nervous system due to cocaine. We develop efficient methods to screen and clean the ECG time series data and extract candidate windows to assess for potential drug use. We then apply our model on the recovery segments from these windows. Our model achieves 100% true positive rate while keeping the false positive rate to 0.87/day over (9+ hours/day of) lab data and to 1.13/day over (11+ hours/day of) field data.

Are We There Yet? Feasibility of Continuous Stress Assessment via Wireless Physiological Sensors.

Stress can lead to headaches and fatigue, precipitate addictive behaviors (e.g., smoking, alcohol and drug use), and lead to cardiovascular diseases and cancer. Continuous assessment of stress from sensors can be used for timely delivery of a variety of interventions to reduce or avoid stress. We investigate the feasibility of continuous stress measurement via two field studies using wireless physiological sensors - a four-week study with illicit drug users (n = 40), and a one-week study with daily smokers and social drinkers (n = 30). We find that 11+ hours/day of usable data can be obtained in a 4-week study. Significant learning effect is observed after the first week and data yield is seen to be increasing over time even in the fourth week. We propose a framework to analyze sensor data yield and find that losses in wireless channel is negligible; the main hurdle in further improving data yield is the attachment constraint. We show the feasibility of measuring stress minutes preceding events of interest and observe the sensor-derived stress to be rising prior to self-reported stress and smoking events.

Enhancement of coupled multichannel images using sparsity constraints.

We consider the problem of joint enhancement of multichannel images with pixel based constraints on the multichannel data. Previous work by Cetin and Karl introduced nonquadratic regularization methods for SAR image enhancement using sparsity enforcing penalty terms. We formulate an optimization problem that jointly enhances complex-valued multichannel images while preserving the cross-channel information, which we include as constraints tying the multichannel images together. We pose this problem as a joint optimization problem with constraints. We first reformulate it as an equivalent (unconstrained) dual problem and develop a numerically-efficient method for solving it. We develop the Dual Descent method, which has low complexity, for solving the joint optimization problem. The algorithm is applied to both an interferometric synthetic aperture radar (IFSAR) problem, in which the relative phase between two complex-valued images indicate height, and to a synthetic multimodal medical image example.