Buprenorphine Extended-release in Jail and at Re-entry: Open-label Randomized Controlled Trial vs. Daily Sublingual Buprenorphine-naloxone
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- # of Participants Retained on Any Form of Community Buprenorphine (Not Randomzied tx) at Week 8
研究概览
简要总结
This is a pilot proof-of-concept randomized controlled trial, open-label and unblinded, examining the feasibility and acceptability of Buprenorphine extended-release vs. daily sublingual buprenorphine-naloxone for the treatment of opioid use disorder in jail and at community re-entry.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults >18yo incarcerated in NYC jails with known release dates.
- •DSM-V criteria for current opioid use disorder (DSM-IV opioid dependence).
- •Currently maintained on sublingual buprenorphine-naloxone in the NYC jail opioid treatment program.
排除标准
- •Individual not interested in XRB treatment. Current SLB patients are otherwise by definition appropriate for XRB.
- •Pregnant or planning conception. A urine dipstick pregnancy (hCG) test will be administered at baseline. The test detects human chorionic gonadotropin (hCG) in urine with a sensitivity/specificity of: 25 mIU hCG/ml, >99%. Time to result is four minutes. If negative, a urine pregnancy test will be administered bi-weekly thereafter to ensure that a participant is not pregnant
- •No severe or acute medical or psychiatric disability preventing safe study participation or making follow-up unlikely.
研究组 & 干预措施
Buprenorphine Extended-Release
XRB is a 300mg pre-mixed subcutaneous injectable formulation to be administered monthly. XRB is for abdominal subcutaneous injection only. Participants in the XRB treatment arm will be given 1 or more XRB injections prior to release from jail and one more at week 5 post-release, depending on their release date.
干预措施: Buprenorphine Extended Release (Drug)
Sublingual Buprenorphine
SLB (SUBOXONE, Zubsolv, or generic tablets) is a daily sublingual film or tablet ranging from 8-24mg/day or equivalent (Zubsolv is dosed 5.7-17.1 mg/day). The film or tablet is placed under the tongue for 5 to 10 minutes until dissolved completely. Participants in the SLB treatment arm will be provided SLB daily by observed dosing in-jail (controlled substances are not self-administered in-jail) and and encouraged to continue SLB treatment in weekly, bi-weekly, or monthly quantities for unobserved, daily, self-administration through week 5. Patients may also elect to obtain SLB care free-of-charge from the Bellevue Hospital Center Addiction Medicine clinic or from non-NYU/Bellevue providers and pharmacies per usual care standards. SLB will not be provided via the study.
干预措施: Sublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets) (Drug)
结局指标
主要结局
# of Participants Retained on Any Form of Community Buprenorphine (Not Randomzied tx) at Week 8
时间窗: 8 Weeks
Retained on any form of community buprenorphine treatment at Week 8
Mean # of Weeks (0-8) on Any Buprenorphine Treatment
时间窗: 8 weeks
Weeks (0-8) on buprenorphine treatment, mean (SD)
# of Participants Retained on Their Randomly Assigned Treatment at Week 8
时间窗: 8 weeks
Retained on assigned treatment at Week 8
Urine Samples Opioid-negative
时间窗: 8 weeks
number of opioid-negative urine samples
the # of Participants Re-incarcerated
时间窗: 8 weeks
Re-incarceration
The Mean In-jail Medical Visits Per Day Following Randomization and Induction on Study Medication
时间窗: Post-randomization and pre-release, (0-3 months)
Jail medical clinic visits per day following study medication induciton, mean
次要结局
- The # of Participants That Received Their Randomly Assigned Study Medication(8 Weeks)
- The # of Participants Who Received Their Randomly Assigned Study Medication Prior to Release From Jail as Scheduled(0-3 months (pre-release))