buprenorphine for individuals in jail

Conditions: Opioid Use Disorder

Summary: this study is an open label randomized controlled trial of extended-release buprenorphine (brixadi, xr-b) vs. sublingual buprenorphine (sl-b) in a large metropolitan jail. an open-label design will randomly assign 240 adults with moderate-to-severe ouds who are soon-to-be-released from jail to either xr-b (n=120) or sl-b (n=120) treatment in jail followed by 6-months of post-release buprenorphine treatment, a 7-month safety visit, and a final long-term follow-up at 12-months.

this study is an open label randomized controlled trial of extended-release buprenorphine (brixadi, xr-b) vs. sublingual buprenorphine (sl-b) in a large metropolitan jail. an open-label design will randomly assign 240 adults with moderate-to-severe ouds who are soon-to-be-released from jail to either xr-b (n=120) or sl-b (n=120) treatment in jail followed by 6-months of post-release buprenorphine treatment, a 7-month safety visit, and a final long-term follow-up at 12-months. aim 1. compare the effectiveness of xr-b vs. sl-b aim 2. to calculate the cost to the state and/or jail/city health system of implementing xr-b and sl-b, and determine the relative value, including the costs associated with the interventions in the community, from a county and state-policymaker and societal perspective. aim 3. explore barriers and facilitators to xr-b versus sl-b implementation in jail: (1) dose induction; (2) diversion and procedures for reducing diversion; (3) continuity of care after release or transfer to another facility; (4) staffing (both custody and medical) needs for daily versus xr-b buprenorphine dosing; and (5) patient preference for xr-b versus sl-b. primary outcome. (a) illicit opioid use (i. urine toxicology; ii. self-reported days of opioid use using timeline followback; and iii. time to opioid relapse). secondary outcomes. (b) retention in buprenorphine treatment (i. days receiving buprenorphine and ii. time to treatment dropout); (c) other illicit substance use (i. urine toxicology; ii. self-reported days of illicit substance use using timeline followback; (d) overdose events (non-fatal and fatal); (e) quality of life (i. physical health; ii. mental health); (f) hiv risk behaviors (i. sexual risk behavior; ii. needle use or sharing); and (g) criminal activity (i. crime days; ii. re-arrest; iii. technical violations; iv. re-incarceration). costs. (a) cost to the correctional system; (b) costs associated with community intervention

Eligibility criteria:
inclusion criteria: * adult male or female inmates at participating jail who are eligible for release within 120 days (sentenced and/or pretrial \[note: individuals who might be sentenced to state/federal prison will be excluded\]); those individuals who are pre-trial and/or sentenced who are completing their sentence in the community (probation, parole, home detention, electronic monitoring, drug or other treatment court \[or equivalent\]) will be eligible to participate; * history of opioid use disorder (meeting dsm-5 criteria of moderate or severe opioid use disorder at the time of incarceration; individuals not meeting the opioid-disorder criterion will be eligible if they were treated in an opioid agonist treatment program during the year before incarceration); * suitability for xr-b and/or sl-b treatment as determined by medical evaluation; * willingness to enroll in xr-b or sl-b treatment in jail and continue in the community; * planning to live in baltimore city or the baltimore region; exclusion criteria: * liver function test levels greater than 5 times normal (if we are unable to obtain labs, a determination by the study physician will be made to allow inclusion); * active medical illness that may make participation hazardous (e.g., unstable diabetes, heart disease; moderate to severe renal impairment; adequately treated medical conditions are acceptable); * conditions or medications that may predispose to qtc prolongation (personal or family history of long qt syndrome, hypokalemia, medications that prolong qtc interval, e.g., macrolide antibiotics, azole antifungal compounds, anti-arrythmics, antipsychotics and antidepressant); * untreated psychiatric disorder that may make participation hazardous (e.g., untreated psychosis, bipolar disorder with mania; adequately treated psychiatric disorders and appropriate psychotropic medications will be allowed); * history of allergic reaction to buprenorphine; * suicidal ideation (within the past 6 months); * inability to pass a study enrollment quiz; and * currently receiving non-buprenorphine moud in jail (methadone, naltrexone).