Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06306443
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-12
First Post:
2024-02-28
Brief Title:
Buprenorphine for Individuals in Jail
Sponsor:
Friends Research Institute Inc
Organization:
Friends Research Institute Inc
Study Overview
Official Title:
A Comparative Effectiveness Trial of Sublingual Versus Extended-release Buprenorphine With Individuals Leaving a Carceral Setting
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 n120 or SL-B n120 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 n120 or SL-B n120 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 andor jailcity 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
Aim 1 Compare the effectiveness of XR-B vs SL-B Aim 2 To calculate the cost to the state andor jailcity 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None