Evaluating Adaptive Dispenser Initiation Protocols for MySafeRx During Post-detox Buprenorphine Treatment- a Pilot Study
Condition: Opioid-use Disorder
MeSH terms: Opioid-Related Disorders
Study type: Interventional

Summary: 
      Opioid overdoses are a significant problem nationwide and novel interventions that can
      prevent overdose by improving buprenorphine treatment for opioid use disorder are a public
      health priority. This study will both investigate the effects of starting remote motivational
      enhancement during inpatient detoxification on rates of engagement in Buprenorphine/ Naloxone
      (B/N) treatment and evaluate the impact of MySafeRx, a mobile device application which
      integrates remote motivational coaching with daily observed dosing from secure electronic
      pill dispensers at home via videoconference, on treatment retention and overdose prevention.
      Broad dissemination of this new intervention could help communities across the nation expand
      and advance their capacity to increase B/N treatment engagement and retention, enhance
      medication adherence, and prevent overdose.
    

Detailed description: 
      The objective of this study is to evaluate an innovative strategy among opioid use disorder
      patients being discharged from detox. This study will evaluate the extent to which remote
      motivational enhancement sessions via videoconference and the option for flexible daily
      dosing at home with MySafeRx can improve engagement and retention with Buprenorphine/Naloxone
      (B/N) treatment after detox in a county where access to B/N treatment has primarily been
      provided with in-person, onsite, daily dosing. This study seeks to expand the investigators
      understanding about what works to prevent opioid overdose by evaluating the effects of remote
      motivational enhancement (RME) sessions provided via videoconferencing at an inpatient detox
      facility and during early treatment in order to increase treatment engagement with daily
      outpatient supervised-dosing of B/N. Participants will use an Android smartphone device to
      access the MySafeRx app and complete their daily motivational interview sessions. In
      addition, the study seeks to evaluate the effects of using a locked medication dispenser. The
      role of the dispenser has not been fully evaluated in the past, and evaluation is needed to
      determine if the dispenser is necessary at the start of a treatment program or only in
      response to those participants having issues with adherence or participants that are
      struggling. This pilot study will generate new knowledge about the most effective way to
      prevent overdose and engage patients in B/N treatment with observed daily dosing.

      Hypothesis:

      The investigators will examine whether acceptable levels of satisfaction with the MySafeRx
      platform, specifically the electronic pill dispenser, are achieved at the end of the pilot
      period.

      Primary Aim:

      Aim 1: To assess the acceptability of the electronic medication dispenser and evaluate the
      impact of using an alternative adaptive assessment-based procedure, by comparing MySafeRx
      Group A (all participants in MySafeRx receive an electronic pill dispenser at the start) and
      MySafeRx Group B (participants only receive the electronic medication dispensers based on
      clinical evaluation and need after assessment at regular time intervals).

      Secondary Aims:

      Aim 2: To examine the differences in positive urine toxicology screens between MySafeRx Group
      A (coaching + medication dispenser) and MySafeRx Group B (coaching + medication dispenser
      based on clinical need)

      Aim 3: To examine medication adherence to B/N by assessing the differences between MySafeRx
      Group A (coaching + medication dispenser) and MySafeRx Group B (coaching + medication
      dispenser based on clinical need) in the total number of observed B/N doses taken in the
      first 28 days, between weeks 3-6.

      Aim 4: To examine the differential impact of two tele-health interventions of MySafeRx Group
      A (coaching + medication dispenser) and MySafeRx Group B (coaching + medication dispenser
      based on clinical need) on retention in outpatient buprenorphine treatment with B/N dosing
      through 24 weeks.

      Exploratory COVID-19 Objectives:

      Aim 5: To examine the differences of COVID-19 infection between MySafeRx Group A and MySafeRx
      Group B and compare with ACTS overall program incidence rate during the time period.
    

Intervention name(s): MySafeRx Inspire Plus; MySafeRx Inspire Flex
Intervention type(s): Other; Other
Intervention description(s): The MySafeRx™ platform is a combination of several key components, including daily videoconferencing check-ins with motivational interviewing-based recovery coaching, text-messaging reminders, secure storage of buprenorphine/naloxone medication within a secure electronic pill dispenser, and a standardized protocol for supervising self-administration of medication via videoconferencing.; The MySafeRx™ platform is a combination of several key components, including daily videoconferencing check-ins with motivational interviewing-based recovery coaching, text-messaging reminders, secure storage of buprenorphine/naloxone medication within a secure electronic pill dispenser, and a standardized protocol for supervising self-administration of medication via videoconferencing. Based on clinical need, the participant may be assigned an electronic pill dispenser for the duration of the study by their clinical team.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment