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临床试验/NCT05837611
NCT05837611撤回不适用

Contingency Management Using Deposit Contract to Reduce Drinking

The University of Texas Health Science Center at San Antonio3 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年6月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
入组人数
80
试验地点
3
主要终点
Transdermal Alcohol Content

研究概览

简要总结

This study will examine the effects of an incentive-based intervention (for reducing alcohol use) that would be sustainable, easily accessible intervention using remote alcohol monitoring and deposit contracts, targeting individuals who would not be reached by more traditional forms of treatment due to barriers such as time constraints, attitudes, and stigma.

详细描述

Deposit contracts are effective at treating a wide variety of problems: smoking cessation, weight loss, and increasing physical activity. Despite the promise of deposit contracts, few earlier studies targeted problem drinking, since doing so required burdensome frequent monitoring - now overcome by remote alcohol monitoring. Earlier work relied on self- and collateral reports, breath alcohol concentrations during clinic visits, or an indirect non-specific marker of alcohol use. Despite these difficulties, earlier studies of deposit contracts were encouraging, with notable increases in: therapy participation; retention ; and abstinence duration compared to previous reports. Collectively, these studies show the potential of deposit contracts to reduce problem drinking but provide only limited evidence of its effectiveness. Still, these studies, and our recent success using contingency management with remote alcohol monitoring, provide a compelling rationale for examining whether a deposit contract program might provide a feasible, effective, and accessible way of helping people reduce drinking. Though there is limited systematic research on deposit contracts, deposit contract programs for various problems are widely available and have proven quite attractive. For example, a deposit contract weight loss website, has over 887,000 users with $62M in incentives paid. However, it is unclear if deposit contracts would be acceptable (and therefore feasible) to individuals interested in reducing their problem drinking. Therefore, we feel that the proposed deposit contract intervention utilizing remote alcohol monitoring could be a widely available and acceptable intervention for problem drinking for three reasons: (1) because of the effectiveness and convenience of our contingency management intervention using remote alcohol monitoring; (2) because of the widespread success of other deposit contract programs like DietBetã; and (3) because the potentially increased attractiveness and effectiveness of an intervention that can return an amount greater than the deposit. The adoption of a deposit contract intervention plus remote alcohol monitoring will only be accelerated by the "FitBit"-style alcohol monitoring devices being developed by many companies (we are currently independently evaluating one such device). However, making deposit contracts widely available will need evidence of their effectiveness, which requires large randomized controlled trials. The purpose of this R21 application is to develop this evidence by demonstrating that deposit contracts with remote alcohol monitoring are feasible and provide evidence of effectiveness needed to design and justify future studies.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • at least 21 years of age,
  • report at least 1heavy drinking episode during the last 28 days;
  • want to reduce their alcohol use;
  • are willing to wear a transdermal alcohol monitor;
  • own a smart phone and
  • are willing and able to deposit $30, $60, or $100 of their choice.

排除标准

  • substance use disorder (except alcohol, nicotine, and/or caffeine);
  • significant alcohol withdrawal symptoms (score ≥ 10 on the Clinical Institute Withdrawal Assessment for Alcohol) or currently in alcohol treatment;
  • medical condition that would contraindicate participation (e.g., pregnancy, scheduled surgery);
  • presence of a Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) psychiatric disorder with symptoms of psychosis and/or delirium; or
  • inability to comprehend informed consent or instructions.

研究组 & 干预措施

Deposit Contract Group

Experimental

During the 2-week intervention, participants will wear a transdermal alcohol monitor and return to our lab twice more (i.e., Visit 1 on the 8th day and Visit 2 on the 15th day from the study entry) to have their monitoring data downloaded from the webserver and payments (if any) determined. Payment will be contingent on the absence of heavy drinking episodes during the previous 7 days. Data from their transdermal alcohol monitor will be automatically processed using previously developed algorithms. When no heavy drinking episode has occurred (no transdermal alcohol concentrations > 0.02 g/dl), participants will be paid 1/2 of their deposit and receive an electronic "bonus" voucher.

干预措施: Deposit Contract (Behavioral)

Deposit Contract Group

Experimental

During the 2-week intervention, participants will wear a transdermal alcohol monitor and return to our lab twice more (i.e., Visit 1 on the 8th day and Visit 2 on the 15th day from the study entry) to have their monitoring data downloaded from the webserver and payments (if any) determined. Payment will be contingent on the absence of heavy drinking episodes during the previous 7 days. Data from their transdermal alcohol monitor will be automatically processed using previously developed algorithms. When no heavy drinking episode has occurred (no transdermal alcohol concentrations > 0.02 g/dl), participants will be paid 1/2 of their deposit and receive an electronic "bonus" voucher.

干预措施: Transdermal Alcohol Monitoring (Other)

结局指标

主要结局

Transdermal Alcohol Content

时间窗: 4 weeks continuously

Measurement produced while wearing Transdermal Alcohol Monitor

次要结局

未报告次要终点

研究者

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

Tara Wright

Assistant Professor

The University of Texas Health Science Center at San Antonio

研究点 (3)

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