跳至主要内容
临床试验/NCT03507075
NCT03507075已完成1 期

Remote Alcohol Monitoring to Facilitate Abstinence Reinforcement: Feasibility

Mikhail Koffarnus0 个研究点目标入组 69 人开始时间: 2014年11月15日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
69
主要终点
Percent days abstinent 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. The goal of this feasibility study is to determine if using technological advancements to remotely, accurately, and securely monitor alcohol use with a newly developed breathalyzer is an effective treatment that is acceptable to participants. If validated, this treatment approach has the potential to facilitate the dissemination of an effective, evidence-based treatment for alcohol dependence to a broader population whose treatment needs are not currently being adequately met.

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

入选标准

  • At least 18 years old
  • Provide written informed consent
  • Meet Diagnostic and Statistical Manual criteria for alcohol use disorder
  • Express a desire to cut down or quit drinking

排除标准

  • Pregnant or lactating
  • Meet Diagnostic and Statistical Manual criteria for other substance use disorder (except caffeine or nicotine)
  • Score 23 or greater on the Alcohol Withdrawal Symptom Checklist
  • Have immediate plans to move out of the area

研究组 & 干预措施

Contingent

Active Comparator

The Contingent group will receive nearly immediate monetary payments over the internet each day they remotely provide negative breathalyzer samples, but will not receive the payments if they provide positive samples or fail to provide samples in a timely manner.

干预措施: Contingency management: Contingent incentives (Behavioral)

Noncontingent

Sham Comparator

The Noncontingent group will receive payments each day they successfully provide samples independent of the alcohol content of those samples.

干预措施: Contingency management: Noncontingent incentives (Behavioral)

结局指标

主要结局

Percent days abstinent from alcohol during intervention

时间窗: Percent days abstinent is the aggregate measure throughout the 21-day intervention period

Three breathalyzer assessments will be collected per day during the treatment period. This outcome measure will consist of the percent days when all three breathalyzers were on time and negative for alcohol.

Treatment acceptability

时间窗: Baseline, one day after treatment end, and at a one-month follow-up

Participant ratings of treatment acceptability will be collected during assessment sessions

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mikhail Koffarnus

Research Assistant Professor

Virginia Polytechnic Institute and State University

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