Opioid Use Disorder
Conditions
Brief 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.
Detailed description
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
Interventions
DRUGextended-release buprenorphine (XR-B)
buprenorphine
Sponsors
Friends Research Institute, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| urine toxicology | 12-months | positive urine drug screen for opioids |
| days of opioid use | 12-months | Number of days since last assessment |
| time to opioid relapse | 12-months | days from release from jail to first relapse event |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| retention in buprenorphine treatment | 6-months | days receiving buprenorphine |
| urine toxicology for other illicit substance use | 12-months | positive urine drug screen |
| days of illicit substance use | 12-months | number of days since last assessment |
| overdose events | 12-months | fatal and non-fatal overdose events |
| PROMIS Patient-Reported Outcomes Measurement Information System - physical health | 12-months | Global physical health score |
| PROMIS Patient-Reported Outcomes Measurement Information System - mental health | 12-months | Global mental health score |
| HIV risk behaviors (Risk Assessment Battery, RAB) - sex risk score | 12-months | sexual risk behavior; Scored 0-18 (higher risk) |
| HIV risk behaviors (Risk Assessment Battery, RAB) needle use or sharing score | 12-months | needle use or sharing; Scored 0-22 (higher risk) |
| criminal activity | 12-months | i. crime days; ii. re-arrest; iii. technical violations; iv. re-incarceration |
Countries
United States
Contacts
CONTACTMichael Gordon, DPA
CONTACTThomas R Blue, PhD
Outcome results
None listed