A Comparative Effectiveness Trial of Sublingual Versus Extended-release Buprenorphine With Individuals Leaving a Carceral Setting
概览
- 阶段
- 3 期
- 干预措施
- extended-release buprenorphine (XR-B)
- 疾病 / 适应症
- Opioid Use Disorder
- 发起方
- Friends Research Institute, Inc.
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- urine toxicology
- 状态
- 招募中
- 最后更新
- 2个月前
概览
简要总结
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.
详细描述
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
研究者
入排标准
入选标准
- •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;
排除标准
- •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).
研究组 & 干预措施
extended-release buprenorphine (XR-B)
Participants will receive sublingual (sl; taken under the tongue) buprenorphine/naloxone doses of 2 mg for two days followed by 4mg for 2 days. The speed of induction will be based on their response to sl buprenorphine/naloxone. If they tolerate sl buprenorphine, on day 4 they will be administered an 8 mg dose of BRIXADI on day 5 (if they do not tolerate sl buprenorphine/naloxone we will extend sl dosing). During week two of dosing, they will receive 16 mg dose of BRIXADI will be given, based on the participant's response to the previous dose. During week three of dosing, they will receive a 24 mg dose of BRIXADI. During week four they will be administered a monthly dose of 64mg, 96mg, or 128mg. In all cases, the dose selected will be based on their response to the previous weeks' dose. We will endeavor to get you on the 96 mg or 128 mg monthly dose as there is a lack of opioid blockade data for the 64 mg monthly dose.
干预措施: extended-release buprenorphine (XR-B)
sublingual buprenorphine (SL-B)
Participants will receive sublingual (sl; taken under the tongue) buprenorphine/naloxone doses of 2 mg for two days followed by 4mg for 2 days. The speed of induction will be based on their response to sl buprenorphine/naloxone.
干预措施: extended-release buprenorphine (XR-B)
结局指标
主要结局
urine toxicology
时间窗: 12-months
positive urine drug screen for opioids
days of opioid use
时间窗: 12-months
Number of days since last assessment
time to opioid relapse
时间窗: 12-months
days from release from jail to first relapse event
次要结局
- PROMIS Patient-Reported Outcomes Measurement Information System - physical health(12-months)
- HIV risk behaviors (Risk Assessment Battery, RAB) - sex risk score(12-months)
- HIV risk behaviors (Risk Assessment Battery, RAB) needle use or sharing score(12-months)
- criminal activity(12-months)
- urine toxicology for other illicit substance use(12-months)
- days of illicit substance use(12-months)
- overdose events(12-months)
- retention in buprenorphine treatment(6-months)
- PROMIS Patient-Reported Outcomes Measurement Information System - mental health(12-months)