A Phase 4, Pilot, Open-label Study of VIVITROL in the Prevention of Re-arrest and Re-incarceration
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Incidence of Subject Re-arrest
研究概览
简要总结
This phase 4 study will evaluate the feasibility of initiating subjects on VIVITROL in prison and continuing VIVITROL upon release into the community.
详细描述
This is an open-label study with a pre-post design. Pre-release opioid-dependent subjects from 4 Baltimore, MD area prisons (three for men and one for women) will receive 1 injection of VIVITROL prior to release from prison and will be offered 6 monthly injections of VIVITROL for 6 months post release. Subjects will complete follow-up visits 1 and 2 months after the last VIVITROL injection. Subjects will be assessed at 10 time points, and adherence to VIVITROL, both in prison and in the community, will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Not currently addicted to opioids, but has a diagnosis of pre-incarceration opioid dependence
- •Inmate at the Metropolitan Transition Center (Baltimore, MD), Maryland Correctional Institute for Women (Jessup, MD), Baltimore Pre-Release Unit (Baltimore, MD), or Jessup Pre-Release Unit (Jessup, MD) and eligible for release within 30 days of screening
- •Expressing a goal of opiate-free treatment upon release
- •Currently opioid free
- •Planning to live in the Baltimore, MD area for at least 8 months following prison release
排除标准
- •Pregnancy and/or breastfeeding
- •Clinically significant active medical condition
- •Active hepatitis
- •Past or present history of an AIDS-indicator disease in subjects who are infected with HIV
- •Any untreated or unstable psychiatric disorder(eg, bipolar with mania)
- •Recent suicidal ideation
- •Current chronic pain diagnosis for which opioids are prescribed
- •Positive drug test for opioids
- •History of drug overdose within the past 3 years requiring inpatient hospitalization
研究组 & 干预措施
VIVITROL
380 mg IM injection
干预措施: VIVITROL 380mg (Drug)
结局指标
主要结局
Incidence of Subject Re-arrest
时间窗: 7 months
Subjects were considered to have had a re-arrest for any new crime or probation/parole violation if the subject had re-arrest records in the official criminal justice records and/or via self-report.
次要结局
- Incidence of Subject Re-incarceration(7 months)
- Opioid Use(7 months)
- Opioid Overdose(7 months)
- Drug Abuse Treatment Program Entry(7 months)
- Retention in the Community(6 months)
- Opioid Craving(8 months)
- Opioid Dependence(7 months)
- Cocaine Use(6 months)
- Criminal Activity(6 months)