Improving Office Based Treatment of Opioid Use Disorder With Technology

The misuse and abuse of opioids is a serious public health problem. SAMHSA estimates that
more than 12 million Americans misuse prescription opioids for nonmedical purposes annually.
The costs of this problem are substantial, both to individuals and society: total costs of
prescription opioid misuse, abuse, and overdose to the US is estimated at $78.5 billion
annually. Additionally, the prevalence of opioid abuse and associated costs are on the rise.
In spite of this, the availability and acceptance of treatment with medications has not kept
pace with the spread of the epidemic.

Prescription of buprenorphine/naloxone (B/N) is intended to address a behavioral health issue
(misuse of opioids) as a component of Medication Assisted Treatment (MAT) for those who are
pharmacologically dependent on opioids. In chronic illness, patient compliance and adherence
with a prescribed regimen has been shown to correlate with treatment success, and conversely
poor patient compliance, commonly documented, correlates with poor outcomes. Studies have
demonstrated that with B/N specifically, compliance is predictive of both relapse and
treatment retention. Relapse events are costly in terms of total healthcare expenditures
(around $15,000 per patient), and personally - upwards of 800,000 years of potential life
lost before the age of 65 in the US alone.

This study seeks to examine the effectiveness of MedicaSafe's BupreCare system in the
delivery of MAT to those with OUD. The BupreCare system is a connected, locking, oral
medication dispenser and secure pill cartridges coupled with an online platform. The system
is programmed with a treatment plan to allow for the dispensation of medications in the right
dose at the right time. Dispensation is recorded and collated in treatment reports to track
patient adherence to their regimen. The project intends to ameliorate issues associated with
MAT by curbing the negative effects of medication nonadherence and diversion, while
simultaneously increasing provider awareness of patient behaviors and needs.

Patients aged 18-65 (inclusive) will be enrolled at two partner sites (Total Health Care and
Artemis Institute) in a field trial. Patients will be maintained on a stable dose of B/N, and
randomized into one of three arms (BupreCare, TAU, or TAU with MEMS tracking). Subjects will
have bi-weekly study visits over the course of 12 weeks. Assessments will be collected at
baseline, and then every 2 weeks following study initiation.

Inclusion Criteria:

- Be between the ages of 18 and 65 years old

- Be able to provide informed consent

- Be English-speaking

- Have consistent phone and/or internet access

- Deemed by physician as medically, psychiatrically, and otherwise appropriate for
buprenorphine therapy

- Maintained on a stable B/N dose

Exclusion Criteria:

- Be younger than 18 or older than 65 years of age

- Chronic pain

- Be non-English speaking

- Be unable to complete informed consent

- Be pregnant