Mobile Medication Adherence Platform for Buprenorphine (MAP4BUP): A Phase I feasibility, usability and efficacy pilot randomized clinical trial.

BACKGROUND/AIM: Poor medication adherence is one of the main barriers to the long-term efficacy of buprenorphine/naloxone (BUP/NAL). The aims of this pilot investigation were to examine if a Bluetooth-enabled pill cap and mobile application is a feasible, usable tool for increasing BUP/NAL adherence among people with an opioid use disorder. METHODS: This pilot randomized clinical trial (RCT; total n = 41) lasted 12 weeks and was conducted in two office-based BUP/NAL provider locations in Spokane, WA and Coeur d'Alene, ID from January 2020 to September of 2021 with an 11-month gap due to COVID-19. Patients receiving BUP/NAL who consented to participate were randomized to receive the pill cap device (PLY group; n = 19) or a service as usual (SAU group; n = 22) group that included an identical but inactive cap for their bottle. The PLY group received reminders via text and voice, and the support of a "helper" (e.g., friend) to monitor pill cap openings. RESULTS: Most participants in PLY group found the device both feasible (92.86 %) and usable (78.57 %). Most participants liked using the device (92.86 %) and were satisfied with the device (85.71 %). While not statistically different from one another, medication adherence per the Medication Possession Ratio was 75 % in the SAU group and 84 % in the PLY group. Pill cap openings were significantly higher in the PLY group with an average of 91.8 openings versus the SAU group's average of 56.7 (p < 0.05). CONCLUSION: The devices was feasible, usable, and patients had high levels of satisfaction. The device was associated with increased pill openings.

Patient-Provider Shared Decision-Making, Trust, and Opioid Misuse Among US Veterans Prescribed Long-Term Opioid Therapy for Chronic Pain.

BACKGROUND: Patient-provider shared decision-making is associated with better treatment adherence and pain outcomes in opioid-specific pain management. One possible mechanism through which shared decision-making may impact pain management outcomes is trust in one's prescribing provider. Elucidating relationships between factors that enhance the patient-provider relationship, such as shared decision-making and trust, may reduce risks associated with opioid treatment, such as opioid misuse. OBJECTIVE: The purpose of this study was to investigate the mediating effect of trust in one's prescribing provider on the relationship between shared decision-making and current opioid misuse. DESIGN: A secondary analysis of data from a prospective cohort study of US Veterans (N = 1273) prescribed long-term opioid therapy (LTOT) for chronic non-cancer pain. PARTICIPANTS: Eligibility criteria included being prescribed LTOT, ability to speak and read English, and access to a telephone. Veterans were excluded if they had a cancer diagnosis, received opioid agonist therapy for opioid use disorder, or evidence of pending discontinuation of LTOT. Stratified random sampling was employed to oversample racial and ethnic minorities and women veterans. MAIN MEASURES: Physician Participatory Decision-Making assessed level of patient involvement in medical decision-making, the Trust in Provider Scale assessed interpersonal trust in patient-provider relationships, and the Current Opioid Misuse Measure assessed opioid misuse. KEY RESULTS: Patient-provider shared decision-making had a total significant effect on opioid misuse, in the absence of the mediator (c = - 0.243, p < 0.001), such that higher levels of shared decision-making were associated with lower levels of reported opioid misuse. When trust in provider was added to the mediation model, the indirect effect of shared decision-making on opioid misuse through trust in provider remained significant (c' = - 0.147, p = 0.007). CONCLUSIONS: Shared decision-making is associated with less prescription opioid misuse through the trust that is fostered between patients and providers.

Patient Feedback on a Mobile Medication Adherence App for Buprenorphine and Naloxone: Closed and Open-Ended Survey on Feasibility and Acceptability.

BACKGROUND: Opioid use disorders impact the health and well-being of millions of Americans. Buprenorphine and naloxone (BUP and NAL) can reduce opioid overdose deaths, decrease misuse, and improve quality of life. Unfortunately, poor medication adherence is a primary barrier to the long-term efficacy of BUP and NAL. OBJECTIVE: We aimed to examine patient feedback on current and potential features of a Bluetooth-enabled pill bottle cap and associated mobile app for patients prescribed BUP and NAL for an opioid use disorder, and to solicit recommendations for improvement to effectively and appropriately tailor the technology for people in treatment for opioid use disorder. METHODS: A convenience sample of patients at an opioid use disorder outpatient clinic were asked about medication adherence, opioid cravings, experience with technology, motivation for treatment, and their existent support system through a brief e-survey. Patients also provided detailed feedback on current features and features being considered for inclusion in a technology designed to increase medication adherence (eg, inclusion of a personal motivational factor, craving and stress tracking, incentives, and web-based coaching). Participants were asked to provide suggestions for improvement and considerations specifically applicable to people in treatment for opioid use disorder with BUP and NAL. RESULTS: Twenty people with an opioid use disorder who were prescribed BUP and NAL participated (mean age 34, SD 8.67 years; 65% female; 80% White). Participants selected the most useful, second-most useful, and least useful features presented; 42.1% of them indicated that motivational reminders would be most useful, followed by craving and stress tracking (26.3%) and web-based support forums (21.1%). Every participant indicated that they had at least 1 strong motivating factor for staying in treatment, and half (n=10) indicated children as that factor. All participants indicated that they had, at some point in their lives, the most extreme craving a person could have; however, 42.1% indicated that they had no cravings in the last month. Most respondents (73.7%) stated that tracking cravings would be helpful. Most respondents (84.2%) also indicated that they believed reinforcers or prizes would help them achieve their treatment goals. Additionally, 94.7% of respondents approved of adherence tracking to accommodate this feature using smart packaging, and 78.9% of them approved of selfie videos of them taking their medication. CONCLUSIONS: Engaging patients taking treatment for opioid use disorder with BUP and NAL allowed us to identify preferences and considerations that are unique to this treatment area. As the technology developer of the pill cap and associated mobile app is able to take into consideration or integrate these preferences and suggestions, the smart cap and associated mobile app will become tailored to this population and more useful for them, which may encourage patient use of the smart cap and associated mobile app.

Automated Reinforcement Management System: Feasibility study findings of an app-based contingency management treatment for alcohol use disorder.

Alcohol Use Disorder (AUD) is the most prevalent substance use disorder in the United States and is directly related to 5% of all annually reported deaths worldwide. Contingency Management (CM) is among the most effective interventions for AUD, with recent technological advancements allowing CM to be provided remotely. Objective: To evaluate the feasibility and acceptability of a mobile Automated Reinforcement Management System (ARMS) designed to provide CM for AUD remotely. Methods: Twelve participants with mild or moderate AUD were exposed to ARMS in a A-B-A within-subject experimental design where they were required to submit three breathalyzer samples per day. During the B phase participants could earned rewards with monetary value for submitting negative samples. Feasibility was determined by the proportion of samples submitted and retention in the study and acceptability was based on participants self-reported experience. Results: The mean number of samples submitted per day was 2.02 out of 3. The proportion of samples submitted in each phase was 81.5%, 69.4% and 49.4%, respectively. Participants were retained for a mean of 7.5 (SD=1.1) out of 8 weeks with 10 participants (83.3%) completing the study. All participants found the app easy to use and stated it helped them reduce their alcohol use. Eleven (91.7%) would recommend the app as an adjunct to AUD treatment. Preliminary indicators of efficacy are also presented. Conclusions: ARMS has shown to be feasible and well accepted. If shown effective, ARMS can serve as an adjunctive treatment for AUD.

Does genetic testing offer utility as a supplement to traditional family health history intake for inherited disease risk?

CONTENT: This study examines the potential utility of genetic testing as a supplement to family health history to screen for increased risk of inherited disease. Medical conditions are often misreported or misunderstood, especially those related to different forms of cardiac disease (arrhythmias vs. structural heart disease vs. coronary artery disease), female organ cancers (uterine vs. ovarian vs. cervical), and type of cancer (differentiating primary cancer from metastases to other organs). While these nuances appear subtle, they can dramatically alter medical management. For example, different types of cardiac failure (structural, arrhythmia, and coronary artery disease) have inherited forms that are managed with vastly different approaches. METHODS: Using a dataset of over 6,200 individuals who underwent genetic screening, we compared the ability of genetic testing and traditional family health history to identify increased risk of inherited disease. A further, in-depth qualitative study of individuals for whom risk identified through each method was discordant, explored whether this discordance could be addressed through changes in family health history intake. FINDINGS: Of 90 individuals for whom genetic testing indicated significant increased risk for inherited disease, two-thirds (66%) had no corroborating family health history. Specifically, we identify cardiomyopathy, arrhythmia, and malignant hyperthermia as conditions for which discordance between genetic testing and traditional family health history was greatest, and familial hypercholesterolaemia, Lynch syndrome, and hereditary breast and ovarian cancer as conditions for which greater concordance existed. CONCLUSION: We conclude that genetic testing offers utility as a supplement to traditional family health history intake over certain conditions.

Exploring the mediating role of baseline urinalysis results on demographic characteristics and stimulant use disorder treatment outcomes.

INTRODUCTION: Baseline stimulant urinalysis (UA) is one of the most reliable predictors of stimulant use disorder treatment outcomes. Yet we know little about the role of baseline stimulant UA mediating the effects of different baseline characteristics on treatment outcomes. OBJECTIVES: This study aimed to explore the potential mediating role of baseline stimulant UA results on the relationship between baseline characteristics and total number of stimulant negative UAs submitted during treatment. METHODS: The study team conducted analyses on data from a multisite randomized clinical trial of contingency management (CM) targeting stimulant use among individuals enrolled in methadone maintenance treatment programs (n = 394). Baseline characteristics included trial arm, education, race, sex, age, and Addiction Severity Index (ASI) composite measures. Baseline stimulant UA was the mediator and total number of stimulant negative UAs provided during treatment was the primary outcome variable. RESULTS: The baseline characteristics of sex (OR = 1.85), ASI drug (OR = 0.01) and psychiatric (OR = 6.20) composites were directly associated with the baseline stimulant UA result (p < 0.05 for all). Baseline stimulant UA result (B = -8.24), trial arm (B = -2.55), ASI drug composite (B = -8.38) and education (B = -1.95) were directly associated with the total number of negative UAs submitted (p < 0.05 for all). The evaluation of indirect effects of baseline characteristics on the primary outcome through baseline stimulant UA revealed significant mediated effects for the ASI drug composite (B = -5.50) and age (B = -0.05; p < 0.05 for both). CONCLUSIONS: Baseline stimulant UA is a strong predictor of stimulant use treatment outcomes and mediates the association of some baseline characteristics and a stimulant use treatment outcome.

Automated Reinforcement Management System (ARMS): focused phase I provider feedback.

BACKGROUND: Alcohol use increases risk for morbidity and mortality and is associated with over 3 million annual deaths worldwide. Contingency Management (CM) is one of the most effective interventions for substance use disorders, and has recently been coupled with technologies to promote novel treatments for alcohol use disorders (AUD). Leveraging these technological advances, we are developing the Automated Reinforcement Management System (ARMS), an integrated CM system designed to enable CM treatment as a component of a digital therapeutic or adjunct therapy remotely to anyone with a smartphone. OBJECTIVE: To collect detailed provider feedback on ARMS and determine the need for modifications to make the system most feasible, acceptable, and useful to providers. METHODS: Seven providers completed one-hour structured interviews/focus groups wherein we described the ARMS system and its application to clinical care. Providers viewed screen shots of the ARMS provider facing and patient facing systems. Providers gave feedback on their current AUD treatment practices, preferences for the functionality and appearance of the system, preferences for receipt of information on their patients, why they and their patients would or would not use the system, suggestions for improvement, and the proposed intervention overall. To analyze the qualitative data gathered, we used a qualitative descriptive approach with content analysis methods. RESULTS: The overarching theme of Individualized Treatment emerged throughout the interviews. This sentiment supports use of ARMS, as it is intended to supplement provider communication and intervention as an adjunctive and customizable tool with the ability to reach rural patients, not a stand-alone option. Themes of Accountability and Objective Assessment arose during discussions of why people would use the system. Themes within provider obstacles included, Information Overload and Clinical Relevance, and in patient obstacles, Sustained Engagement and Security Concerns. Two themes emerged regarding suggestions for improvement: Increasing Accessibility and Bi-directional Communication. DISCUSSION: Themes from provider input are being used to modify ARMS to make it more user friendly, time saving, and relevant to treatment of AUD. If successful, ARMS will provide effective, individualized-digital therapeutic for those needing adjunctive treatment or those living in rural remote areas needing better connected care.

Sociodemographic and clinical profile of crack cocaine treatment-seeking individuals living in "Crackland", Brazil / Perfil sociodemográfico e clínico de indivíduos em busca de tratamento para o uso de crack que vivem na "Cracolândia"

OBJECTIVE: São Paulo's Crackland is the biggest and oldest open drug use scene in Brazil, yet little is known about the profile of crack cocaine treatment-seeking individuals living in this region. The aim of this crossectional study was to describe the demographics and clinical characteristics of treatment-seeking crack users living in the Crackland region. METHODS: A sample of nighty eight individuals were screened for DSM-V substance use disorders, including substance use, impulsiveness, and psychiatric symptoms. Recent crack cocaine use was also tested using biologic specimens. RESULTS: Results indicated severe social vulnerability, as participants experienced high rates of homelessness (46.9%), unstable housing (50%), unemployment (60.4%) and early school drop-out (27.5%). The average age of crack use onset was 20 years (SD = 6.9) and the mean duration of continuous crack use was 15 years (SD = 9.7). Most participants presented with concomitant mental health disorders, particularly alcohol use disorder (87.8%), as well high rates of psychiatric symptomatology and impulsiveness. More than half of the sample reported at least one previous inpatient (73.5%) and outpatient (65.3%) addiction treatment attempt. CONCLUSION: This population profile should inform mental healthcare services, promoting the provision of tailored assistance by targeting specific demands at all levels of treatment.

OBJETIVO: Localizada em São Paulo, a Cracolândia é o maior e mais antigo cenário aberto de uso de drogas do Brasil. Ainda assim, pouco se sabe sobre o perfil dos indivíduos que vivem nessa região e buscam tratamento para crack. O objetivo deste estudo transversal foi descrever características demográficas e clínicas de usuários de crack vivendo na região da Cracolândia que estão em busca de tratamento. MÉTODOS: Noventa e oito indivíduos foram avaliados para transtornos por uso de substâncias do DSM-V, padrão de uso de substâncias, impulsividade e sintomatologia psiquiátrica. O uso recente de crack também foi determinado por meio de coleta de amostras toxicológicas. RESULTADOS: Os resultados indicaram grave vulnerabilidade social, com significativas prevalências de falta de moradia (46,9%), moradia instável (50%), desemprego (60,4%) e abandono escolar precoce (27,5%). A idade média de início do uso de crack foi de 20 anos (DP = 6,9) e a duração média do uso contínuo do crack foi de 15 anos (DP = 9,7). A maioria dos participantes apresentou alguma comorbidade psiquiátrica, particularmente transtorno por uso de álcool (87,8%), bem como altas taxas de sintomatologia psiquiátrica e impulsividade. Mais da metade da amostra relatou pelo menos uma tentativa anterior de tratamento por internação (73,5%) e ambulatorial (65,3%). CONCLUSÃO: Os achados desse estudo permitem um maior entendimento do perfil e das necessidades de usuários de crack vivendo na região da Cracolândia e podem ajudar serviços de saúde especializados em dependência química a promoverem uma assistência mais direcionada às demandas específicas dessa população.

Acceptability and feasibility of incorporating contingency management into a public treatment program for homeless crack cocaine users in Brazil: A pilot study.

Homeless substance users are particularly hard to treat. In this pilot study, we evaluated the acceptability and feasibility of incorporating Contingency Management (CM) into a public Abstinent-Contingent Housing (ACH) treatment program developed to treat currently homeless crack cocaine users. A total of 21 homeless crack cocaine users were randomized to receive 12 weeks of ACH alone (n = 9) or ACH plus CM (ACH + CM) (n = 12). Twelve treatment providers in the ACH treatment program were trained to deliver the CM intervention. CM was rated as relatively (41.7%) or very (58.3%) easy to understand and relatively (50%) or very (50%) easy to conduct by the ACH treatment providers. On a 10-point Likert scale, providers rated the importance of incorporating CM into public treatment programs for crack cocaine at M = 8.3 (SD = 2). Participants exposed to CM rated as relatively (33.3%) or very (66.7%) easy to understand. One hundred percent liked receiving the intervention "a lot," and 78.9% believed it helped them achieve and maintain crack cocaine abstinence. Finally, compared to the ACH condition, the ACH + CM condition was consistently associated with better treatment retention and cocaine use outcome measures, yelling small to large effect sizes. However, possibly due to the small sample size, most of these differences did not achieve statistical significance. CM was well integrated into the ACH treatment program and was well accepted by both the providers and participants, suggesting the feasibility of incorporating CM into a public treatment program for homeless crack cocaine users from low- and middle-income countries. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Effectiveness of incorporating contingency management into a public treatment program for people who use crack cocaine in Brazil. A single-blind randomized controlled trial.

BACKGROUND: Smoked cocaine (i.e., crack use) is a severe health problem in Brazil, with the country being reported as having the largest crack market in the world. The objective of this study was to evaluate the effectiveness of incorporating Contingency Management targeting cocaine abstinence into a public treatment program in Brazil. METHODS: Single-blind randomized controlled trial conducted at Unidade Recomeço Helvétia (URH), a public ambulatory treatment program for persons who use crack and live in the "Crackland" region in downtown São Paulo, Brazil. In total, 98 treatment-seeking individuals who use crack were randomized to one of two treatment conditions. Participants allocated to the control condition (n = 48) received 12 weeks of the standard treatment provided at URH. Participants allocated to the experimental condition (n = 50) received the same treatment in combination with Contingency Management (URH+CM). In URH+CM, participants were provided with vouchers with monetary value for submission of negative cocaine urinalysis twice weekly. RESULTS: Compared to the URH group, the URH+CM group was significantly more likely to submit a negative cocaine urinalysis during treatment, with odds ratios ranging from 4.17 to 6.78, depending on how missing data was accounted for (p<0.01). Participants receiving Contingency Management also had higher odds of achieving three or more weeks of continuous abstinence (OR= 8.07; 95% CI [2.48, 26.24]), achieved longer durations of abstinence (B = 2.14; 95% CI [0.67, 3.61]), submitted a higher percentage of negative urinalysis (B = 19.85; 95% CI [6.89, 32.82]), and were retained in treatment for a longer period (B = 3.00; 95% CI [1.04, 4.97]), compared to those receiving URH alone (p<0.01 for all). CONCLUSIONS: The incorporation of Contingency Management was effective in promoting cocaine abstinence and treatment retention. The large-scale dissemination of Contingency Management may be an effective strategy to treat Brazilians with cocaine use disorders.

Validating the clinical relevance of alternative stimulant use treatment outcome measures by examining their association with 3-month follow-up outcomes.

The lack of a consensus on empirically supported and clinically meaningful outcome measures for stimulant use disorders (SUDs) continues to undermine the development and evaluation of effective behavioral and pharmacological treatment options. The aim of this study was to evaluate the clinical relevance of four stimulant use treatment outcome measures (longest duration of abstinence [LDA], percent of negative urinalysis submitted, abstinent in the last 2 weeks of treatment, and three or more weeks of continuous abstinence) by exploring their utility via association with stimulant and alcohol use, employment and legal problems, and severity of psychiatric symptomatology collected at follow-up. Data used in these secondary analyses came from a multisite randomized contingency management treatment trial for SUDs (n = 441) conducted through the NIDA Clinical Trials Network. Multiple regression analyses were conducted to explore the association of four stimulant use treatment outcome measures and eight 3-month follow-up outcomes. The percent of negative urinalysis outcomes showed the most consistent performance compared to alternative outcomes, being significantly associated with better responses in all eight 3-month follow-up outcomes (ß range: -169 to -241, p < .01). Both dichotomous outcome measures showed similar performances being significantly associated with four follow-up outcomes (ß range: -159 to -203, p < .01). All outcome measures were consistently associated with better outcome responses at the 3-month follow-up, adding support to their clinical relevance and their adoption in SUD treatment trials. The two dichotomous outcome measures are reliable candidates to be used as endpoint outcomes, as recommended by the U.S. Food and Drug Administration (FDA). (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Patient Activation, Depressive Symptoms, and Self-Rated Health: Care Management Intervention Effects among High-Need, Medically Complex Adults.

The purpose of this randomized controlled trial (n = 268) at a Federally Qualified Health Center was to evaluate the outcomes of a care management intervention versus an attention control telephone intervention on changes in patient activation, depressive symptoms and self-rated health among a population of high-need, medically complex adults. Both groups had similar, statistically significant improvements in patient activation and self-rated health. Both groups had significant reductions in depressive symptoms over time; however, the group who received the care management intervention had greater reductions in depressive symptoms. Participants in both study groups who had more depressive symptoms had lower activation at baseline and throughout the 12 month study. Findings suggest that patients in the high-need, medically complex population can realize improvements in patient activation, depressive symptoms, and health status perceptions even with a brief telephone intervention. The importance of treating depressive symptoms in patients with complex health conditions is highlighted.

Long-term functioning to provide empirical support for the clinical relevance of treatment outcomes for methamphetamine use disorders.

BACKGROUND: Research has yet to empirically evaluate methamphetamine (MA) use outcome measures commonly used to indicate treatment success. Clinically meaningful outcomes must be associated with long-term functioning in important life domains. This study evaluated the association between different MA use outcomes and long-term life-functioning. METHOD: The data that this study used in its secondary analyses were pooled from two treatment trials for MA use disorders (n = 237). The study conducted multiple regression analyses (with multiple imputation for missing data) to determine the association of six within-treatment MA use outcome measures with problem severity in seven life domains and a proxy measure for overall functioning, measured with the Addiction Severity Index (ASI) and assessed at an 8-month follow-up. RESULTS: The longest duration of abstinence (LDA) outcome achieved the most consistent performance, being associated with better scores in five of eight ASI outcomes (ß ranging from -0.203 to -0.291; p < .01). The complete abstinence during treatment demonstrated the poorest performance and was not significantly associated with any of the ASI outcomes. All other MA use outcome measures were significantly (p < .01) associated with at least one ASI outcome. CONCLUSION: This study provides empirical support for the use of LDA as a clinically relevant indicator of treatment success for MA use disorders, while also indicating the limitations of using complete abstinence during treatment to determine treatment success. Based on these findings, providers and researchers should use LDA as a primary outcome for MA use disorder treatments and trials.