Search

Background Treatment with opioid agonists is effective for opioid use disorder, but early discontinuation of treatment is a major obstacle to success. Intensive longitudinal methods — which take many repeated measurements over time, usually in the field— have provided unique insight into the effects of stress, mood and craving on drug use while people are being treated; these methods might also be useful for studying the processes that lead people to drop out of treatment. Methods Ecological momentary assessment (EMA) was conducted for up to 17 weeks by obtaining multiple electronic diary entries per day from 238 participants being treated with methadone or buprenorphine-naloxone. Survival analysis was used to study two outcomes: dropping out of treatment and noncompliance with EMA self-report requirements. Self-reports of stress, craving, and mood were used as time-varying predictors. Demographic and psychosocial variables measured with the Addiction Severity Index at the start of treatment were used as time-invariant predictors. Results Dropping out of treatment was more likely in participants with more reported hassles (a measure of stress), higher levels of cocaine craving, lower levels of positive mood, a recent history of emotional abuse, a recent history of being bothered frequently by psychological problems, and with buprenorphine rather than methadone as their medication. In contrast, study noncompliance was not significantly associated with any of the variables analyzed. Conclusions Assessment of stress, craving and mood during treatment might identify people who are at greater risk of dropping out, and therapeutic interventions targeting these processes might increase retention.

Background and aims Stress can be validly assessed “live” or by a summary evaluation of the very recent past. Using smartphone-based ecological momentary assessment (EMA) combined with end-of-day (EOD) entries, we assessed the association between daily hassles, stressful events and use of opioids and cocaine, in opioid- and cocaine-using men and women. Methods For up to 16 weeks, 161 outpatients in opioid-agonist treatment who reported cigarette smoking carried smartphones on which they reported stressful events (SEs) and drug use (DU) and completed an EOD questionnaire to report hassles encountered throughout the day, current perceived stress, cigarettes/day, and current mood. We compared EOD responses on days with and without SE and DU reports and on days when thrice-weekly urine drug screens indicated opioid or cocaine use or abstinence. Results Participants (N = 161) made 11,544 EOD entries; EMA SEs were reported on 861 (7.5%) days, and DUs on 1685 (14.6%) days. The most frequently reported hassles in EOD entries were “not enough money” (31.4% of daily reports) and maintaining abstinence (18.7%). Total EOD hassles showed small but statistically significant associations [odds ratios (95% CIs)] with EMA SEs [1.09 (1.06–1.13)], DUs [1.08 (1.06–1.10)], and urine-positive opioid [1.06 (1.04–1.09)] and cocaine [1.03 (1.00–1.06)] results. Men and women had similar rates (mean/day (SD)) of hassles: men 2.25 (3.55); women 2.55 (3.76) (F1,159 = 0.53, p = 0.47). Conclusions Daily hassles, reported at the end of the day, are associated with both same-day stressful events and drug use. Monitoring hassles and devising specific coping strategies might be useful therapeutic targets.

Responses to stress and drug craving differ between men and women. Differences in the momentary experience of stress in relation to craving are less well-understood.Using ecological momentary assessment (EMA), we examined sex differences in real-time in two areas: (1) causes and contexts associated with stress, and (2) the extent to which stress and drug cues are associated with craving.Outpatients on opioid-agonist treatment (135 males, 47 females) reported stress, craving, and behavior on smartphones for 16 weeks. They initiated an entry each time they felt more stressed than usual (stress event) and made randomly prompted entries 3 times/day. In stress-event entries, they identified the causes and context (location, activity, companions), and rated stress and craving severity.The causes reported for stress events did not differ significantly by sex. Women reported arguing and being in a store more often during stress events, and men reported working more often during stress events, compared to base rates (assessed via random prompts). Women showed a greater increase in opioid craving as a function of stress (p 0.0001) and had higher stress ratings in the presence of both stress and drug cues relative to men (p 0.01). Similar effects were found for cocaine craving in men (p 0.0001).EMA methods provide evidence based on real-time activities and moods that opioid-dependent men and women experience similar contexts and causes for stress but differ in stress- and cue-induced craving. These findings support sex-based tailoring of treatment, but because not all participants conformed to the overall pattern of sex differences, any such tailoring should also consider person-level differences.

RATIONALE: Ecological momentary assessment (EMA) of specific events usually focuses more on antecedents and concomitants than on aftermaths. OBJECTIVES: To examine mental state both before and after discrete episodes of stress and drug use. METHODS: For up to 16 weeks, outpatients on opioid-agonist treatment carried smartphones on which they initiated entries for stressful events (SEs) or lapses to drug use (DUs), and thrice daily when randomly prompted (RPs). Participants rated their stress, opioid craving, cocaine craving, and moods. RP entries within 5 hours of an event were analyzed and compared to other RPs. RESULTS: Stress, negative mood, and craving were generally higher before and after DUs and SEs compared to background levels in participants with at least one DU (n=149) or SE (n=158). Before DUs, there were increases in negative mood, opioid craving, and cocaine craving, but not background stress. Before SEs, there were increases in background stress, opioid craving, and cocaine craving, but not negative mood. These changes were more variable after events than before. Neither DUs nor SEs were significantly related to positive mood. CONCLUSIONS: Stress increased before stressful-event entries, but was less evident before drug use. Craving increased in the hours before drug use and stressful events—and remained elevated in the hours after either event. These results suggest a stronger link between drug use and craving than between drug use and stress. Lapses to drug use did not improve mood or reduce stress, at least not at our one-hour-bin time resolution, suggesting that if such benefits exist, they are brief.

We sought to develop and deploy a video-based smartphone-delivered mobile HIV Risk Reduction (mHIVRR) intervention to individuals in an addiction treatment clinic. We developed 3 video modules that consisted of a 10-minute HIVRR video, 11 acceptability questions, and 3 knowledge questions and deployed them as a secondary study within a larger study of ecological momentary and geographical momentary assessments. All 24 individuals who remained in the main study long enough completed the mHIVRR secondary study. All 3 videos met our a priori criteria for acceptability “as is” in the population: they achieved median scores of ≤2.5 on a 5-point Likert scale; ≤20% of the individuals gave them the most negative rating on the scale; a majority of the individuals stated that they would not prefer other formats over video-based smartphone-delivered one (allP<0.05). Additionally, all of our video modules met our a priori criteria for feasibility: ≤20% of data were missing due to participant noncompliance and ≤20% were missing due to technical failure. We concluded that video-based mHIVRR education delivered via smartphone is acceptable, feasible and may increase HIV/STD risk reduction knowledge. Future studies, with pre-intervention assessments of knowledge and random assignment, are needed to confirm these findings.

Introduction and Aims. A challenge in treatment research is the necessity of adhering to protocol and regulatory strictures while maintaining flexibility to meet patients' treatment needs and to accommodate variations among protocols. Another challenge is the acquisition of large amounts of data in an occasionally hectic environment, along with the provision of seamless methods for exporting, mining and querying the data. Design and Methods. We have automated several major functions of our outpatient treatment research clinic for studies in drug abuse and dependence. Here we describe three such specialised applications: the Automated Contingency Management (ACM) system for the delivery of behavioural interventions, the transactional electronic diary (TED) system for the management of behavioural assessments and the Protocol Workflow System (PWS) for computerised workflow automation and guidance of each participant's daily clinic activities. These modules are integrated into our larger information system to enable data sharing in real time among authorised staff. Results. ACM and the TED have each permitted us to conduct research that was not previously possible. In addition, the time to data analysis at the end of each study is substantially shorter. With the implementation of the PWS, we have been able to manage a research clinic with an 80 patient capacity, having an annual average of 18 000 patient visits and 7300 urine collections with a research staff of five. Finally, automated data management has considerably enhanced our ability to monitor and summarise participant safety data for research oversight. Discussion and Conclusions. When developed in consultation with end users, automation in treatment research clinics can enable more efficient operations, better communication among staff and expansions in research methods. [Vahabzadeh M, Lin J-L, Mezghanni M, Epstein DH, Preston KL. Automation in an addiction treatment research clinic: Computerised contingency management, ecological momentary assessment and a protocol workflow system. Drug Alcohol Rev 2009;28:3–11]

Infection with hepatitis C virus (HCV) is a complex public health problem with a high prevalence of chronic infection, an increasing prevalence of HCV-associated disease, low rates of testing and treatment, and the prospect of increasing incidence associated with intravenous drug use (IVDU; Smith, Jorgensen, Zibbell, & Beckett, 2012). IVDU is a major risk factor for HCV, and HCV prevalence is exceedingly high among intravenous drug users (Schreuder et al., 2010). A study conducted in Baltimore, MD, found that the seroprevalence of HCV among intravenous drug users was 77%, with most individuals becoming positive within the first year of initiating IVDU (Garfein, Vlahov, Galai, Doherty, & Nelson, 1996). IVDU does not directly influence HCV progression despite the potential for multiple repeat exposures to various HCV genotypes, but HCV progression may be accelerated by several factors associated with IVDU, including excess alcohol intake, reduced access and adherence to treatment, and poor nutrition (Cooper & Mills, 2006). Given the adverse public health consequences of HCV infection and its link to HIV, improved approaches to reducing the spread of HCV, particularly among intravenous drug users, are needed. Although there is strong evidence that medication-assisted addiction treatment reduces drug misuse, HIV-risk behaviors, and HIV infection rates (Metzger, Woody, & O’Brien, 2010; Millson et al., 2007), the corresponding evidence for HCV remains controversial (Crofts, Nigro, Oman, Stevenson, & Sherman, 1997; Selvey, Denton, & Plant, 1997; Thiede, Hagan, & Murrill, 2000), suggesting that approaches beyond medication-assisted treatment alone are needed to curb HCV-risk behaviors and infection rates. Given that risk behaviors persist during addiction treatment (Chaudhry et al., 2011) and are more likely among patients who do not know their HCV status (Vidal-Trecan, Coste, Varescon-Pousson, Christoforov, & Boissonnas, 2000), one approach might be to test people for hepatitis C upon addiction-treatment admission and inform them of the results. Unawareness of HCV status is common. In one study, 72% of HCV+ and 46% of HCV− intravenous drug users were unaware of their HCV status (Hagan et al., 2006). However, even after diagnosis with HCV, high-risk behaviors continue (Hagan et al., 2006; Ompad, Fuller, Vlahov, Thomas, & Strathdee, 2002). The initial diagnosis of HCV had a strong, negative emotional effect in almost half of a patient group that was not primarily composed of intravenous drug users (Fabris et al., 2006). For intravenous drug users, an HCV diagnosis is sometimes thought to be less momentous than for nonintravenous drug users, but that may not always be true (Treloar & Rhodes, 2009). As for possible emotional effects of the disease process itself, there seems to be no published research; phenomenological studies of hepatitis C focus on patients who have begun antiviral treatment, which can produce psychiatric side effects of its own (Sgorbini, O’Brien, & Jackson, 2009). What is unknown is whether ongoing risk behavior is increased by the negative emotional effect of HCV diagnosis itself or by other factors in the lived experience of HCV+ individuals not on antiviral treatment. The analyses presented here are part of a project to better understand the factors influencing drug use and lapse and improve approaches to reducing high-risk behaviors. We have followed up on prior research in our laboratory showing that HCV+ patients in methadone maintenance report higher drug-related HIV-risk behaviors and are more likely to test positive for opioids compared with HCV− patients (Willner-Reid, Belendiuk, Epstein, Schmittner, & Preston, 2008). Our treatment-research clinic uses ecological momentary assessment (EMA), a technique for collection of in-the-field, first-person data using handheld computers. EMA largely eliminates recall bias by collecting self-report in near real time and produces time-stamped data that are amenable to statistical aggregation (Shiffman, Stone, & Hufford, 2008). We have previously reported success with EMA in a study of over 100 heroin- and cocaine-using methadone-maintained patients and shown that cocaine-use events are preceded by increasing exposure to drug-use triggers and are associated with craving, stress, and tobacco use (Epstein, Marrone, Heishman, Schmittner, & Preston, 2010; Epstein & Preston, 2010; Epstein et al., 2009; Preston et al., 2009). In the analyses reported here, we determine whether HCV+ and HCV− individuals are differentially exposed, in their daily lives, to triggers of craving and drug use, and we explore the relationship of HCV status with demographics and momentary moods in patients whose HCV is not yet overtly symptomatic in an effort to inform treatment interventions for reduction of HCV-risk behavior and infection rates.

Optimizing screening and evaluation process is essential in maximizing recruiting potential participants into clinical trials. We developed a clinical recruiting system used in the management of human research studies whereby recruiting for various protocols are conducted at multiple sites by different groups with process interdependencies. The system is developed based on a multi-tier architecture with a series of real-time and on-demand decision support systems to increase the efficiency of screening and evaluation of participants during a recruiting process. It simulates various conditions by using derivation rules and recruiting templates for automatic generation of checklists in order to recommend the optimum selection rules based on existing participants' data and is seamlessly integrated into our large human research information system, a comprehensive electronic health record (EHR) system for research participants.

Computerized testing methods have long been used for presenting clinical questionnaires and are regarded as an efficient and accurate data collection mechanism in human research settings. In order to adapt to the constant addition of new research protocols and incorporate the new data collection forms and questionnaires into our computerized medical information environment, it is necessary to have a solution that requires no modifications to the source code for creating new questionnaires and renders the results in a Web browser-based format that can be seamlessly integrated into our patient records system. In this paper we describe our test and questionnaire system (TQS) that addresses our requirements and provides full-page browser-based assessments. In addition to managing the new questionnaires, TQS seamlessly communicates and incorporates the clinician-generated assessments built on and for a handheld electronic diary system and provides a powerful and user-friendly data extraction mechanism that allows full or selective data export for further analysis. This solution not only employs both a generic building tool and a flexible data model, but also renders the required questionnaires in a Web browser-based environment making it possible for the collected data to become an integral part of our browser-based human research information system. Since its implementation 4 years ago, this system has been used to generate approximately 300 questionnaires at our site and is designed to provide the necessary adaptability and flexibility required for all of the current and potentially a very high percentage of future protocols.