A Randomized, Controlled Trial of Sublingual Buprenorphine through Telemedicine vs In-Person Care as Usual in the Treatment of Opioid Use Disorder

Opioid Use Disorder (OUD) effects 1.6 million Americans per year, and contributes to significant
morbidity and mortality, driven by the opioid overdose epidemic. Despite 3 FDA approved, effective medication
treatments for OUD (MOUD), among all people affected by OUD, only a fraction engage in effective MOUD,
and of those, an even smaller fraction remain in treatment long enough to achieve stable remission. While the
COVID-19 pandemic resulted in widespread disruption in the existing treatment landscape for OUD, it also
highlighted opportunities for applications of technology in the treatment of OUD, including widespread
utilization of telehealth, that were further supported by multi-level regulatory changes. Prescribers in traditional
brick-and-mortar clinics and start-up telehealth businesses quickly adapted to the new environment in utilizing
telemedicine as a primary means of providing MOUD. In March 2020, utilization of telehealth in the US
increased 154% in less than 1 month. Advocates of telehealth for MOUD identify improved access, increased
feasibility, and convenience with diminished stigma as potential benefits. Despite the largescale embrace of
telehealth for MOUD during the last year, evidence points to a differentially negative impact of the COVID-19
pandemic on patients with OUD, including increased overdose death rates. There are limitations of telehealth
as compared to in-person care, including greater risk of diversion or misuse of prescribed medications. Best
practices, such as how to complete high fidelity drug screening or which patients may be better suited to in
person care, have not been established and have not been able to keep up with the pace of provider adoption
of telehealth, particularly as practitioners without addiction training provide MOUD.
As vaccination rates against SARS-Co-V2 increase, along with the opportunity to provide safe, in-
person care, understanding the benefits and limitations of telehealth MOUD vs in-person care is critically
important, especially as it has the potential to impact regulatory changes far beyond the pandemic. Haste in
the public health crisis did not permit an evidence-based approach to allow for comparative effectiveness
research trials in the use of telehealth MOUD and in-person MOUD.
We propose an early Phase II clinical trial, in which 50 patients seeking MOUD will be randomly
assigned to one of two arms: Arm 1 will receive in-person induction and maintenance dosing of sublingual
buprenorphine, or MOUD as usual, and Arm 2 will complete induction and maintenance dosing of sublingual
buprenorphine through comprehensive telehealth sessions, telehealth MOUD, utilizing a standardized protocol
for each healthcare provider session that has been developed by our addiction specialists. This telehealth
protocol serves as a model of the integration of evidence-based practices in MOUD and could be used by non-
addiction specialists at scale. Our primary outcome will be retention in treatment for 12-weeks. To date, this
would be the first prospective, randomized, controlled trial comparing telehealth MOUD to MOUD as usual.

Grant Number: 5R21DA055835-02
NIH Institute/Center: NIH
Principal Investigator: Christina Brezing