extended release naltrexone versus extended release buprenorphine with individuals leaving jail

Conditions: Opioid-use Disorder

Summary: the proposed study is a type 1 hybrid effectiveness-implementation trial. individuals with opioid use disorder in county jails throughout the state of maryland will be randomly assigned within gender within jail to one of two groups: arm 1. xr-b (n=120). xr-b in jail followed by 6 monthly injections post-release at a community treatment program. arm 2. xr-ntx (n=120). one injection of xr-ntx in jail, followed by 6 monthly injections post-release at a community treatment program.

this study is a type 1 hybrid effectiveness-implementation trial. county jails willing to provide extended-release naltrexone (xr-ntx) and extended-release buprenorphine (xr-b) will participate in a randomized controlled trial throughout the state of maryland, in which 240 incarcerated men and women will be randomly assigned within gender within jail to one of two arms: arm 1. xr-b (n=120). xr-b in jail followed by 6 monthly injections post-release at a treatment program. arm 2. xr-ntx (n=120). xr-ntx in jail, followed by 6 monthly injections post-release at a treatment program. in addition to the rct the investigators will use a learning collaborative to examine the acceptability and feasibility of medications for opioid use disorder (mouds). aim 1. to determine the effectiveness of xr-b compared to xr-ntx in terms of: primary. (a) pharmacotherapy adherence (number of monthly injections received). secondary. (b) illicit opioid urine test results; (c) self-reported illicit opioid use; (d) overdose events (non-fatal and fatal); (e) quality of life (i. physical health; ii. mental health); (f) hiv risk behaviors (i. sexual behavior; ii. needle use or sharing); and (g) criminal activity (i. crime days; ii. re-arrest; iii. re-incarceration). aim 2. to use a learning collaborative involving all 7 rct county jurisdictions as well as 3 additional counties that selected not to participate in the randomized trial to understand factors related to: (a) acceptability of providing long-acting agonists and antagonists in jail settings; and (b) feasibility of providing medication continuity of care from jail to community treatment providers. aim 3. calculate the cost to the correctional health system of implementing an xr-b or xr-ntx program, and determine the relative value of each strategy, including the costs associated with the subsequent interventions in the community, from a state-policymaker and societal perspective.

Eligibility criteria:
inclusion criteria: * adult male or female inmates at participating jails who are eligible for release within 120 days * 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 xr-ntx treatment as determined by medical evaluation * willingness to enroll in xr-b or xr-ntx treatment in jail * planning to live in one of the 7 participating counties and/or surrounding counties exclusion criteria: * liver function test levels greater than 4 times normal; * 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 naltrexone and/or buprenorphine; * current chronic pain diagnosis for which opioids are prescribed; * pregnancy (for women); * breast-feeding (for women); * suicidal ideation (within the past 6 months); * body mass index (bmi) \> 40; * inability to pass a study enrollment quiz; * currently enrolled in jail-based moud pharmacotherapy (methadone, buprenorphine, naltrexone) * enrolled in a methadone treatment program in the past 30 days.