Remote Alcohol Monitoring to Facilitate Abstinence Reinforcement With an Underserved Population
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 91
- 试验地点
- 4
- 主要终点
- Pattern of abstinence from alcohol during intervention
研究概览
简要总结
Directly reinforcing abstinence from alcohol with monetary incentives is an effective treatment for alcohol dependence, but barriers in obtaining frequent, verified biochemical measures of abstinence limit the dissemination of this treatment approach. As our feasibility study demonstrates, remote breathalyzer monitoring drastically improves the practicality of delivering an alcohol contingency management intervention. In Experiment 2, we will test whether the addition of remote abstinence incentives to treatment as usual improves outpatient treatment outcomes and prevents relapse following inpatient detoxification at a regional hospital system. We will also assess whether readmission rates are reduced using a newly developed smartphone app and breathalyzer.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recently completed or currently completing an alcohol detoxification program through the Carilion Clinic or University of Kentucky Healthcare system.
- •Meet DSM-V criteria for alcohol use disorder.
- •Abstinent from alcohol at the time of consent.
排除标准
- •Alcohol use disorder is secondary to another substance use disorder.
研究组 & 干预措施
Active Comparator: Group A (Intensive incentives)
Group A will have the opportunity to earn payments based on the results of their breathalyzer screens. Participants will receive a compliance incentive per submitted sample regardless of the results, but will also have the opportunity to earn more incentives for providing negative results. For the first 3 weeks, these additional incentives will scale based on the number of consecutive days of sustained negative samples. For the remaining weeks incentives will be based on a randomized "prize" drawing.
干预措施: Contingency Management (Behavioral)
Active Comparator: Group B (Prize-based incentives)
Group B will have the opportunity to earn payments based on the results of their breathalyzer screens. Participants will receive a compliance incentive per submitted sample regardless of the results, but will only have the opportunity to earn more incentives based on a randomized "prize" drawing if they submit a negative sample.
干预措施: Contingency Management (Behavioral)
Sham Comparator: Group C (Intensive incentives)
Group C serves as a direct control group to Group A and will follow the same incentive procedures, however participants will receive incentives regardless of the results of their samples.
干预措施: Contingency management (Behavioral)
Sham Comparator: Group D (Price-based incentives)
Group D serves as a direct control group to Group B and will follow the same incentive procedures, however participants will receive incentives regardless of the results of their samples.
干预措施: Contingency management (Behavioral)
No Intervention: Group E (no incentives)
Group E will have no monitoring intervention, they will only complete assessment sessions.
结局指标
主要结局
Pattern of abstinence from alcohol during intervention
时间窗: up to 66 weeks
Breathalyzer assessments will be collected during the treatment period. This outcome measure will consist of the percentage of days without alcohol use as detected by the breathalyzers.
Time to relapse
时间窗: A total of 12 assessment sessions spanning over a 66 week period
For this outcome, we will conduct survival analyses to compare relapse across study groups.
Treatment acceptability
时间窗: A total of 12 assessment sessions spanning over a 66 week period
Participant ratings of treatment acceptability on a customized Treatment Acceptability questionnaire will be collected during assessment sessions. Each question will be scored from 1 (low) to 4 (high) and will assess distinct components of the treatment. Questions will be interpreted and scored individually and not be summed together.
次要结局
未报告次要终点
研究者
Mikhail N Koffarnus
Associate Professor
University of Kentucky