Extended-release Naltrexone (Vivitrol) for the Treatment of Alcohol Dependence in Urban Primary Care: a Feasibility Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Percent of Patients Initiating Vivitrol Treatment Who Receive 3 Consecutive Monthly Vivitrol Injections
研究概览
简要总结
Naltrexone is an opioid antagonist with a high affinity for the mu opioid receptor. The efficacy of extended-release naltrexone (Vivitrol) as a treatment for alcohol dependence has been demonstrated in clinical trials, raising the prospect of integrating pharmacologic treatment for alcohol dependence into general medical care settings. However, the feasibility of implementing this United States Food and Drug Administration approved treatment in the front-line settings in which it is most needed has not been demonstrated. This is an open-label pilot feasibility study of implementing treatment with Vivitrol in primary care medical clinics in a safety net hospital system affiliated with an urban academic center.
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
- •Current alcohol dependence
- •Age 18 or older
- •English or Spanish-speaking
- •Without untreated severe mental illness
- •Liver enzymes (alanine aminotransferase and aspartate aminotransferase) ≤ 3x normal
- •Kept 2 of last 3 clinic primary care appointments and/or has a working telephone number at which can be contacted directly
- •Either a) currently abstinent (e.g., referred from an inpatient 'detox' setting) or b) with the ability, in the clinician's judgment, to achieve and maintain abstinence
- •If female of child-bearing potential, must be using adequate contraception
- •Able to understand study procedures
排除标准
- •Currently opioid dependent or requiring ongoing treatment with opioids for any indication
研究组 & 干预措施
Extended release injectable naltrexone
干预措施: Extended release injectable naltrexone (Vivitrol) (Drug)
结局指标
主要结局
Percent of Patients Initiating Vivitrol Treatment Who Receive 3 Consecutive Monthly Vivitrol Injections
时间窗: 4 months
次要结局
未报告次要终点
研究者
Marc Gourevitch
Director of General Internal Medicine
NYU Langone Health