MySafeRx™: An Integrated Mobile Platform for Buprenorphine Adherence

Study Overview
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Brief Summary
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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
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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.

Official Title
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MySafeRx™: An Integrated Mobile Platform for Buprenorphine Adherence

Conditions
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Opioid Use Disorder

Intervention / Treatment
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* Other: MySafeRx™


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women and men age 18-39, inclusive, who are competent, wish to participate and willing to provide informed consent. DSM-V diagnosis of opioid use disorder, moderate or severe 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: DSM-V diagnosis of dementia, neurodegenerative disease, or other organic mental disorder, mental retardation, or autism. Substantial cognitive impairment (Montreal Cognitive Assessment < 25/30) Currently homeless Actively homicidal or suicidal with an imminent plan 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Care<br>Standard Care through office-based opioid treatment with buprenorphine/naloxone and weekly urine toxicology screening | |
| Experimental: Standard Care + MySafeRx™ Intervention<br>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. This arm represents Standard Care plus MySafeRx™. | Other: MySafeRx™<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of subjects with adequate medication adherence | Feasibility will be demonstrated by MySafeRx achieving supervised self-administration of B/N on >= 30 out of the first 42 days (equivalent to an average of 5 out of 7 days) for at least 2/3 of subjects randomized to MySafeRx. | Day 42 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability | Level of patient acceptability (mean score > 3 out of 5 on the 13-item satisfaction scale) | Day 42 | 
| Usability | Reported patient usability (mean score > 68 on the system usability scale) | 42 days | 
| Initial Clinical Efficacy-Illicit opioid use | Percent negative weekly opioid urine toxicology | 6 weeks | 
| Initial Clinical Efficacy-Medication adherence | Weekly self-reports of B/N adherence | 6 weeks |