Long-Acting Injectable Naltrexone Treatment of Alcohol Dependence in Primary Care vs. in Specialized Chemical Dependence Treatment: A Pilot Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Primary Outcomes: Feasibility of an injectable naltrexone study in the primary care setting.
研究概览
简要总结
The goal of the proposed project is to improve the primary care treatment of veterans with alcohol dependence. Alcohol dependence is a common behavioral health problem among veterans treated in VA primary care clinics. However, assessment and treatment of alcohol dependence in primary care remains problematic. Assessment of veterans with positive alcohol use screens may not always be completed and referrals to specialty care may not always be made. Moreover, the use of medications for alcohol dependence among veterans is rare, despite VA treatment guidelines that recommend such use. Finally, when medications are prescribed, patients may have difficulties with adherence.
The primary aim of this study is to assess the feasibility of long-acting injectable naltrexone provided through primary care (LAN/PC) versus long-acting injectable naltrexone in the specialized chemical dependence clinic (LAN/CDC). The secondary aim is to obtain preliminary assessments of the relative effectiveness of long-acting injectable naltrexone in primary care versus in the chemical dependence clinic.
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 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must be males or non-pregnant females between the ages of 18 and 69 who are receiving their primary medical care at the Syracuse VAMC.
- •Participants must meet DSM-IV diagnostic criteria for current alcohol dependence.
- •Participants must report drinking within the thirty days prior to study entry.
- •Participants must receive approval from their primary care provider for study participation.
- •Participants must be willing to consider accepting at least one of the two treatment conditions.
排除标准
- •Participants with a current DSM-IV diagnosis of current opioid abuse or dependence, or in opioid withdrawal
- •AST level is greater than 3 times the upper limit of the normal range
- •Participants with a medical condition requiring opioid medication or a severe allergy to naltrexone
- •Participants who received outpatient treatment at the Syracuse VA Chemical Dependence Clinic in the past 90 days
- •Any unstable medical or psychiatric conditions in the judgment of the principal investigator or the participants primary care provider
结局指标
主要结局
Primary Outcomes: Feasibility of an injectable naltrexone study in the primary care setting.
次要结局
- Secondary Outcome: Effectiveness of long-acting injectable naltrexone in primary care versus in the chemical dependence clinic.
研究者
Steven Batki, M.D.
Professor
State University of New York - Upstate Medical University