Assessing Optimal XR-Buprenorphine Initiation Points in Jail
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Proportion of Participants who Receive XR-B within 28 Days Prior to Jail Release
研究概览
简要总结
The goal of this study is to compare two approaches for commencing pharmacotherapy with injectable buprenorphine for opioid use disorder (OUD) among jail inmates: (1) at the time of admission or (2) shortly before release. A sample of eligible inmates with sentences of less than 180 days will be randomly assigned to (1) initiating extended-release buprenorphine (XR-B) treatment at the time of admission (n=80), or (2) initiating XR-B treatment within 30 prior to their scheduled release date (n=80). The groups will be compared with regard to (1) how likely they were to participate in treatment, (2) levels of in-jail opioid use (via post-release interviews), (3) continuation of pharmacotherapy and other OUD treatment in the community, and (4) levels of opioid use 4 and 12 weeks following discharge (self-report and incentivized voluntary urine tests).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Incarcerated adults able to provide written informed consent in English.
- •Currently sentenced with pending release date between 3-7 months.
- •Current moderate-to-severe opioid use disorder (DSM-5)
- •Reasonable likelihood of completing 3-months or longer of community treatment (i.e., no plans to be transferred out of state or to another correctional facility)
- •Willing to accept being randomized to initiating XR-B treatment at the time of jail admission or near the time of release.
排除标准
- •Severe medical or psychiatric disability making participation unsafe or regular follow-up unlikely, including patients with pre-existing moderate to severe hepatic impairment are not eligible to participate
- •Pregnancy, planning conception, or breast-feeding
- •Allergy, hypersensitivity or medical contraindication to either medication
- •Chronic pain requiring opioid pain management
- •On methadone or buprenorphine (SL-B) maintenance prior to incarceration AND intending to remain on methadone or buprenorphine maintenance upon return to the community.
研究组 & 干预措施
XR-B Induction at Admission
Participants will initiate extended-release buprenorphine (XR-B) treatment at the time of admission. XR-B will be continued monthly from the time of induction to the day of release (up to 6 months), and up to 3 monthly injections will be offered in the community following release.
Dosing: XR-B is available in two doses, 300mg and 100mg. Study clinicians will generally adhere to FDA-labeling on XR-B dosing, which recommends two months of 300-mg doses followed by maintenance doses of 100-mg monthly.
干预措施: Extended-Release Buprenorphine Injection (Drug)
XR-B Induction at Pre-Release
Participants will initiate extended-release buprenorphine (XR-B) treatment within 30 days of release. Participants will receive at least one XR-B monthly injection prior to release, and XR-B will be continued monthly from the time of induction to the day of release. Up to 3 monthly injections will be offered in the community following release.
Dosing: XR-B is available in two doses, 300mg and 100mg. Study clinicians will generally adhere to FDA-labeling on XR-B dosing, which recommends two months of 300-mg doses followed by maintenance doses of 100-mg monthly.
干预措施: Extended-Release Buprenorphine Injection (Drug)
结局指标
主要结局
Proportion of Participants who Receive XR-B within 28 Days Prior to Jail Release
时间窗: Up to Month 6
Data derived from clinic records.
次要结局
- Proportion of Participants who Initiate Medication for Opioid Use Disorder (MOUD) during Incarceration Period(Up to Month 6)
- Number of Days of Opioid Use at 1 Month Post-Release(1 Month Post-Release (Up to Month 7))
- Number of Days of Opioid Use at 3 Months Post-Release(3 Months Post-Release (Up to Month 10))
- Mean Opioid Craving Visual Analogue Scale (OC-VAS) Score during Incarceration Period(Up to Month 6)
- Mean K-6 Distress Scale Score during Incarceration Period(Up to Month 6)
- Proportion of Participants who Receive a Dose of XR-B Within 28 Days after Jail Release(1 Month Post-Release (Up to Month 7))