Clinical trial NCT02778282: MySafeRx™: An Integrated Mobile Platform for Buprenorphine Adherence
Official title: MySafeRx™: An Integrated Mobile Platform for Buprenorphine Adherence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Use Disorder
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2016-05-19
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percent of subjects with adequate medication adherence
timeFrame: Day 42
Secondary outcomes:
measure: Acceptability
timeFrame: Day 42
measure: Usability
timeFrame: 42 days
measure: Initial Clinical Efficacy-Illicit opioid use
timeFrame: 6 weeks
measure: Initial Clinical Efficacy-Medication adherence
timeFrame: 6 weeks
Other outcomes:
measure: Treatment Retention
timeFrame: 6 weeks
measure: Crisis and Hardship in Administering Office-Based Opioid Treatment (OBOT) Scale
timeFrame: 8 weeks
measure: Cost effectiveness ratio
timeFrame: 3 months
Locations:
city: Somerville
country: United States
facility: Cambridge Health Alliance Outpatient Addiction Services
state: Massachusetts
city: Bennington
country: United States
facility: Hawthorn Recovery Center
state: Vermont
city: Bennington
country: United States
facility: Mount Anthony Primary Care
state: Vermont
Study officials:
affiliation: Dartmouth College
name: Zev D Schuman-Olivier, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schuman-Olivier Z, Weiss RD, Hoeppner BB, Borodovsky J, Albanese MJ. Emerging adult age status predicts poor buprenorphine treatment retention. J Subst Abuse Treat. 2014 Sep;47(3):202-12. doi: 10.1016/j.jsat.2014.04.006. Epub 2014 May 20.
citation: Aaron Bangor, Philip T. Kortum & James T. Miller (2008) An Empirical Evaluation of the System Usability Scale, International Journal of Human-Computer Interaction, 24:6, 574-594, DOI: 10.1080/10447310802205776
citation: Schuman-Olivier Z, Borodovsky JT, Steinkamp J, Munir Q, Butler K, Greene MA, Goldblatt J, Xie HY, Marsch LA. 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. Addict Sci Clin Pract. 2018 Sep 24;13(1):21. doi: 10.1186/s13722-018-0122-4.