Preliminary Effectiveness of Remotely Monitored Blood Alcohol Concentration Device as Treatment Modality
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Alcohol Time Line Follow Back (TLFB)
研究概览
简要总结
State the scientific aim(s) of the study, or the hypotheses to be tested. The purpose of the current study is to evaluate the usage and acceptability of the Soberlink's blood alcohol concentration (BAC) unit in collaboration with Aware treatment to assess increased sobriety within patients suffering from alcohol use disorder (AUD).
The specific AIMS will be:
- To determine the effectiveness of Soberlink's ability to increase abstinence
- To evaluate the impact of Soberlink's device on the participant based on their quality of health and sobriety.
- To evaluate the extent to which need for higher levels of follow-up care and treatment is reduced for individuals who have had access to the Soberlink device.
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
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •are at least 21 years old,
- •currently enrolled at Aware In home treatment,
- •Primary or secondary DSM-5 diagnosis of alcoholism use disorder (AUD).
排除标准
- •Current suicide or homicide risk,
- •meet criteria for DSM-IV current psychotic disorder, or bipolar disorder,
- •does not have phone access with text message capabilities
- •Unable to read or understand English,
- •Unable to complete the study because of anticipated incarceration or move,
- •Life-threatening or unstable medical problems,
- •No course of current or pending legal action,
- •Soberlink results being used for child custody or legal circumstance.
结局指标
主要结局
Alcohol Time Line Follow Back (TLFB)
时间窗: up to 24 weeks
The Alcohol TLFB is a drinking assessment method that obtains estimates of daily drinking and has been evaluated with clinical and nonclinical populations. Using a calendar, people provide retrospective estimates of their daily drinking over a specified time (previous month). The Alcohol TLFB allows several dimensions of a person's drinking to be separately examined: (a) variability (i.e., scatter); (b) pattern (i.e., shape); and (c) extent of drinking (i.e., elevation; how much).
次要结局
- Mean Positive BAC Response With Soberlink(up to 24 weeks)
- Alcohol Abstinence Self-efficacy Scale for Confidence(up to 24 weeks)
- Alcohol Abstinence Self-efficacy Scale for Temptation.(up to 24 weeks)
- Quality of Life Survey(up to 24 weeks)
研究者
Frank D Buono, PHD
Associate Research Scientist
Yale University