A protocol for a randomized comparison of extended-release versus sublingual buprenorphine among pre-trial detainees in jail.

CONTEXT/

BACKGROUND

The high prevalence of opioid use among jailed adults offers an unmatched opportunity to identify and treat those with opioid use disorder (OUD), a population that is at a substantial risk for post-release overdose. From a public health perspective, jails are critical touchpoints, as these facilities typically admit more than 7 million adults per year. One clinical consideration is whether pre-trial detainees with OUD would benefit from early induction onto extended-release buprenorphine (XRB).

METHODS/STUDY

DESIGN

In this 3-year randomized controlled trial, we will identify and recruit 200 incarcerated adults with OUD who are receiving sublingual buprenorphine (SLB) or tolerate a SLB test dose and randomize them to receive extended release buprenorphine (XRB) (n = 100) or to remain on SLB (n = 100) while in custody. Study participation will continue through their pre-trial time in jail (up to 6 months) or until they are sentenced or released. Community treatment will then be tracked for 90 days following release. In addition to collecting data on XRB uptake in jail, we will assess (1) the percentage of XRB and SLB study participants leaving jail with a clinically active dose of buprenorphine in their system, (2) 90- day post-release MOUD continuation, (3) levels of buprenorphine diversion while in custody, and (4) recidivism and death (90 days). "Clinically active" is defined as receiving XRB within the past 28 days or SLB in the past 24 h.

DISCUSSION: Findings from this study will demonstrate the feasibility and outcomes of inducting pre-trial adults with OUD onto XRB, as well as offer practical clinical and policy guidelines for best practices for treating this high risk and understudied population.