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 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.

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.