Opioid-use Disorder Clinical Trial
Official title:
Pilot for Improved Office Based Treatment of Opioid-Dependence
The goal of this study is to evaluate whether using a novel drug-device combination to deliver buprenorphine/naloxone (B/N) to patients in office-based treatment for Opioid Use Disorder (OUD) is an effective way to improve compliance and treatment outcomes. The system introduces psychological and behavioral supports in addition to securing the medication between doses.
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 Friends Research 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.
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