4/15/16 - 3/31/21
Zev Schuman-Olivier, MD
Other Project Staff
Jacob Borodovsky; Qays Munir; Jackson Steinkamp; Lisa A. Marsch, PhD; Haiyi Xie, PhD; Mark McGovern, PhD
Opioid use disorder represents a serious public health issue. Rates of overdose deaths have been rising among young adults. Additionally, acute Hepatitis C (HCV) infection rates are increasing fast among young adults, especially in rural areas. 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 retention in outpatient treatment and decreases risk of transmitting HCV. Younger adults have difficulty stabilizing, achieving abstinence, and remaining active in office-based opioid treatment (OBOT) with B/N as compared to older adults. Retaining young adults in B/N treatment is important because dropout is linked with relapse and overdose death. Low levels of adherence to buprenorphine during treatment is associated with dropout from treatment, therefore an intervention that supports medication adherence among young adults during periods of instability during OBOT may offer a critical mechanism for improving treatment outcomes among young adults with opioid use disorder.
MySafeRx™ is a novel integrated mobile platform for medication adherence. This innovative solution has the potential to be a new gold standard for remote adherence monitoring and diversion prevention. The MySafeRx™ platform, which was designed specifically for use with controlled substances, such as B/N, during addiction and mental health treatment, focuses on simultaneously enhancing medication adherence, preventing medication diversion, and providing daily recovery coaching support during periods of clinical instability (e.g. patients with opioid use disorder receiving OBOT with B/N). MySafeRx™ uses a mobile application that provides the capacity for daily remote supervised self-administration of B/N by integrating confidential text messaging, daily videoconferencing with visual observation of medication taking, and secure, electronic medication dispensers (i.e., Medicasafe 3000 device). The MySafeRx™ remote check-in coaching encounter, provides relational recovery coaching and motivational enhancement, during a critical daily window around the time of medication taking. Finally, by providing regular reports to prescribers through a dedicated prescriber web interface, MySafeRx™ increases prescribers’ awareness of the level of medication adherence and recovery stability.
This study aims to assess feasibility of a 6-week course of the MySafeRx™ integrated platform provided for a population of vulnerable young adults (<34 years old) with opioid use disorder, enrolling patients during B/N induction and established B/N patients with recent illicit opioid use. The study aims to evaluate both patient and prescriber levels of acceptability and usability, and assess treatment effects on evaluation of patient stability over time. Finally, this study also aims to evaluate initial clinical efficacy of MySafeRx™ compared to standard care based on weekly TLFB self-reports of B/N adherence and on percent negative weekly opioid urine toxicology (during 6 weeks of trial).