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      MySafeRx: a mobile technology platform integrating motivational coaching, adherence monitoring, and electronic pill dispensing for enhancing buprenorphine/naloxone adherence during opioid use disorder treatment: a pilot study

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          Abstract

          Background

          While buprenorphine/naloxone (B/N) is approved for opioid use disorder treatment, effective delivery of B/N comes with significant challenges. Most notably, many patients do not take medication daily as prescribed; this non-adherence worsens treatment outcomes, increases healthcare costs, and leads to persistent worries of diversion among providers and policymakers. The present study examines the feasibility, usability, and acceptability of MySafeRx—a mobile technology platform integrating motivational coaching, adherence monitoring, and electronic pill dispensing designed to address the challenges of office-based opioid treatment (OBOT) with B/N.

          Methods

          The MySafeRx platform integrates electronic pill dispensers, text-messaging, and videoconferencing to provide supervised self-administration of medication and daily motivational coaching through an Android app interface. High-risk early adults (18–39 years old) who were enrolled in OBOT with B/N and had documented illicit opioid use in the past month during opioid agonist therapy (n = 12) participated in a 28-day single-arm observational study of the MySafeRx platform in addition to standard care.

          Results

          Two-thirds of participants who completed the study achieved an average of > 5 days per week of supervised B/N self-administration. Visual confirmation of medication adherence was demonstrated for an average of 72% of study days among all participants. All participants achieved platform technical proficiency within 60 min, reporting good levels of usability and acceptability. Illicit opioid abstinence rates confirmed by urine toxicology increased by 53% during MySafeRx but fell 43% within 3 weeks post-intervention.

          Conclusion

          The MySafeRx medication adherence and remote coaching mobile platform is acceptable and can be feasibly implemented in real-world opioid use disorder treatment settings during high-risk periods (i.e., initial stabilization, after illicit opioid lapse), resulting in reduced illicit opioid use; however, the effect did not last after intervention completion, suggesting longer duration or extended taper of program may be needed.

          ClinicalTrials.Gov NCT02942199 10/24/16 https://clinicaltrials.gov/ct2/show/NCT02942199

          Electronic supplementary material

          The online version of this article (10.1186/s13722-018-0122-4) contains supplementary material, which is available to authorized users.

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          Most cited references51

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          Emerging adulthood. A theory of development from the late teens through the twenties.

          J Arnett (2000)
          Emerging adulthood is proposed as a new conception of development for the period from the late teens through the twenties, with a focus on ages 18-25. A theoretical background is presented. Then evidence is provided to support the idea that emerging adulthood is a distinct period demographically, subjectively, and in terms of identity explorations. How emerging adulthood differs from adolescence and young adulthood is explained. Finally, a cultural context for the idea of emerging adulthood is outlined, and it is specified that emerging adulthood exists only in cultures that allow young people a prolonged period of independent role exploration during the late teens and twenties.
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            A role for brain stress systems in addiction.

            Drug addiction is a chronically relapsing disorder characterized by compulsion to seek and take drugs and has been linked to dysregulation of brain regions that mediate reward and stress. Activation of brain stress systems is hypothesized to be key to the negative emotional state produced by dependence that drives drug seeking through negative reinforcement mechanisms. This review explores the role of brain stress systems (corticotropin-releasing factor, norepinephrine, orexin [hypocretin], vasopressin, dynorphin) and brain antistress systems (neuropeptide Y, nociceptin [orphanin FQ]) in drug dependence, with emphasis on the neuropharmacological function of extrahypothalamic systems in the extended amygdala. The brain stress and antistress systems may play a key role in the transition to and maintenance of drug dependence once initiated. Understanding the role of brain stress and antistress systems in addiction provides novel targets for treatment and prevention of addiction and insights into the organization and function of basic brain emotional circuitry.
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              Adjunctive counseling during brief and extended buprenorphine-naloxone treatment for prescription opioid dependence: a 2-phase randomized controlled trial.

              No randomized trials have examined treatments for prescription opioid dependence, despite its increasing prevalence. To evaluate the efficacy of brief and extended buprenorphine hydrochloride-naloxone hydrochloride treatment, with different counseling intensities, for patients dependent on prescription opioids. Multisite, randomized clinical trial using a 2-phase adaptive treatment research design. Brief treatment (phase 1) included 2-week buprenorphine-naloxone stabilization, 2-week taper, and 8-week postmedication follow-up. Patients with successful opioid use outcomes exited the study; unsuccessful patients entered phase 2: extended (12-week) buprenorphine-naloxone treatment, 4-week taper, and 8-week postmedication follow-up. Ten US sites. Patients A total of 653 treatment-seeking outpatients dependent on prescription opioids. In both phases, patients were randomized to standard medical management (SMM) or SMM plus opioid dependence counseling; all received buprenorphine-naloxone. Predefined "successful outcome" in each phase: composite measures indicating minimal or no opioid use based on urine test-confirmed self-reports. During phase 1, only 6.6% (43 of 653) of patients had successful outcomes, with no difference between SMM and SMM plus opioid dependence counseling. In contrast, 49.2% (177 of 360) attained successful outcomes in phase 2 during extended buprenorphine-naloxone treatment (week 12), with no difference between counseling conditions. Success rates 8 weeks after completing the buprenorphine-naloxone taper (phase 2, week 24) dropped to 8.6% (31 of 360), again with no counseling difference. In secondary analyses, successful phase 2 outcomes were more common while taking buprenorphine-naloxone than 8 weeks after taper (49.2% [177 of 360] vs 8.6% [31 of 360], P < .001). Chronic pain did not affect opioid use outcomes; a history of ever using heroin was associated with lower phase 2 success rates while taking buprenorphine-naloxone. Prescription opioid-dependent patients are most likely to reduce opioid use during buprenorphine-naloxone treatment; if tapered off buprenorphine-naloxone, even after 12 weeks of treatment, the likelihood of an unsuccessful outcome is high, even in patients receiving counseling in addition to SMM.
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                Author and article information

                Contributors
                617-591-6056 , zschuman@cha.harvard.edu
                jacob.borodovsky@gmail.com
                jacksonsteinkamp@gmail.com
                qays.munir@gmail.com
                Kyle.Butler@dartmouth.edu
                Mary.Ann.Greene@dartmouth.edu
                jonah.goldblatt@tufts.edu
                Haiyi.Xie@dartmouth.edu
                Lisa.A.Marsch@dartmouth.edu
                Journal
                Addict Sci Clin Pract
                Addict Sci Clin Pract
                Addiction Science & Clinical Practice
                BioMed Central (London )
                1940-0632
                1940-0640
                24 September 2018
                24 September 2018
                2018
                : 13
                : 21
                Affiliations
                [1 ]ISNI 0000 0001 2179 2404, GRID grid.254880.3, Center for Technology and Behavioral Health, , Geisel School of Medicine at Dartmouth, ; Hanover, USA
                [2 ]ISNI 000000041936754X, GRID grid.38142.3c, Department of Psychiatry, , Harvard Medical School, ; Boston, USA
                [3 ]ISNI 000000041936754X, GRID grid.38142.3c, Cambridge Health Alliance, Outpatient Addiction Services, Department of Psychiatry, , Harvard Medical School, ; 26 Central Street, Somerville, MA 02143 USA
                [4 ]ISNI 0000 0004 0367 5222, GRID grid.475010.7, Boston University School of Medicine, ; Boston, USA
                [5 ]ISNI 0000 0000 8934 4045, GRID grid.67033.31, Tufts University School of Medicine, ; Boston, USA
                Author information
                http://orcid.org/0000-0001-9216-2039
                Article
                122
                10.1186/s13722-018-0122-4
                6154900
                30249279
                f9977695-dace-4357-a828-9122291db613
                © The Author(s) 2018

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 27 December 2017
                : 18 September 2018
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/100000026, National Institute on Drug Abuse;
                Award ID: P30DA029926
                Award ID: R34DA040086
                Award ID: R43DA033702
                Award Recipient :
                Categories
                Research
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                © The Author(s) 2018

                Health & Social care
                Health & Social care

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