MySafeRx™: An Integrated Mobile Platform for Buprenorphine Adherence
Condition: Opioid Use Disorder
MeSH terms: Opioid-Related Disorders
Study type: Interventional

Summary: 
      The goal of the MySafeRx study is to evaluate the feasibility, acceptability, and usability
      of a novel platform that integrates text messaging reminders, secure electronic pill
      organizers, and daily remote brief motivational recovery support visits with a standardized
      protocol for supervised self- administration of buprenorphine via videoconferencing.
    

Detailed description: 
      Opioid use disorder is a serious public health issue. Buprenorphine/ Naloxone (B/N) is a
      partial opioid mu-receptor agonist dosed daily that prevents opioid withdrawal, blocks opioid
      euphoria and can prevent opioid overdose. Extended treatment with B/N increases rates of
      abstinence and outpatient treatment retention and decreases Hepatitis C (HCV) transmission.
      B/N treatment dropout is associated with relapse and overdose death.

      B/N adherence may be a critical factor influencing retention and reducing overall healthcare
      costs. Also, B/N diversion is associated with poor adherence and has become increasingly
      common and worrisome. While many patients achieve stability after starting B/N treatment,
      more than 80% of 18-25 year olds leave treatment within a year with relapse as the most
      common reason. Ongoing illicit opioid use during treatment increases odds of relapse and
      dropout. The MySafeRx™ platform helps prescribers offer a higher level of support for
      vulnerable patients with opioid use disorder during periods of clinical instability. 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 B/N medication within a secure electronic pill
      dispenser, and a standardized protocol for supervising self-administration of medication via
      videoconferencing. By offering this recovery support and medication adherence monitoring
      program during periods of instability, this system could improve treatment outcomes by
      ensuring increased adherence, while also preventing B/N diversion.

      This study primarily seeks to demonstrate the feasibility, acceptability, and usability of
      the MySafeRx™ platform among young adults (18-39 years, inclusive) with opioid use disorders.
      While each key component may have an individual therapeutic effect, we hypothesize that an
      integrated process involving all key components may be necessary to unlock the full
      therapeutic potential of a mobile platform for daily remote supervised self-administration
      and diversion prevention among this group. Providing targeted motivational interviewing and
      recovery support at this context-specific moment of daily medication-taking when people are
      very receptive to treatment may offer a new opportunity for expanding how recovery support
      can be delivered. Usability will be assessed with the validated system usability scale as a
      primary outcome. Feasibility, acceptability and initial efficacy based on opioid urine
      toxicology will all be assessed as secondary outcomes.
    

Intervention name(s): MySafeRx™
Intervention type(s): 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 medication within a secure electronic pill dispenser, and a standardized protocol for supervising self-administration of medication via videoconferencing.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment