MySafeRx™: An Integrated Mobile Platform for Buprenorphine Adherence

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.

Inclusion Criteria:

1. Women and men age 18-39, inclusive, who are competent, wish to participate and willing
to provide informed consent.

2. DSM-V diagnosis of opioid use disorder, moderate or severe

3. Seeking to initiate buprenorphine treatment or currently receiving buprenorphine
treatment but had recent positive illicit opioid urine toxicology or missed scheduled
urine toxicology.

Exclusion Criteria:

1. DSM-V diagnosis of dementia, neurodegenerative disease, or other organic mental
disorder, mental retardation, or autism.

2. Substantial cognitive impairment (Montreal Cognitive Assessment < 25/30)

3. Currently homeless

4. Actively homicidal or suicidal with an imminent plan

5. Serious unstable medical illness including, cardiovascular, hepatic, renal,
respiratory, endocrine, neurological, or hematological disease such that
hospitalization for treatment of that illness is likely within the next 3 months.