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经皮酒精传感器联合依随管理用于减少酒精依赖患者酒精摄入量的研究:一项试点可行性随机对照试验方案。

Use of Transdermal Alcohol Sensors in Conjunction With Contingency Management to Reduce Alcohol Consumption in People With Alcohol Dependence Attending Alcohol Treatment Services: Protocol for a Pilot Feasibility Randomized Controlled Trial.

机构信息

Department of Addiction, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, United Kingdom.

Department of Public Health, Environments and Society at London School of Hygiene and Tropical Medicine, King's College London, London, United Kingdom.

出版信息

JMIR Res Protoc. 2024 Jul 31;13:e57653. doi: 10.2196/57653.

Abstract

BACKGROUND

Wearable technology for objective, continuous, and reliable alcohol monitoring has been developed. These are known as transdermal alcohol sensors (TASs). They can be worn on the wrist or ankle with the sensor pressed against the skin and can measure sweat vapors being emitted from the skin, to record transdermal alcohol concentration (TAC). Previous studies have investigated the accuracy and acceptability of the available TAS brands, but there has been little research into their use in people with alcohol use disorders (AUD).

OBJECTIVE

This feasibility randomized controlled trial aims to explore the feasibility, strengths, and limitations of using a TAS to monitor alcohol consumption in individuals in treatment for AUD with or without contingency management (CM) to promote abstinence or low-level alcohol consumption.

METHODS

The target sample size is 30 (15 randomized to each group). Participants will be recruited through poster adverts at alcohol services. Both groups (control and CM) will wear the TAS (BACtrack Skyn) for 2 weeks in the context of their usual treatment, meeting with the researcher every other weekday. In the last meeting, the participants will complete a postwear survey on their experience of wearing the TAS. The CM group will also receive small financial incentives for low or no alcohol consumption, as measured by the TAS. On days where the TAC peak is below a set threshold (<115.660 g/L), CM group participants will be rewarded with a £5 (US $6.38) voucher. There are financial bonuses if this target is achieved on consecutive days. The researcher will monitor TAC for each day of the study at each research visit and allocate financial incentives to participants according to a set reinforcement schedule.

RESULTS

The first participant was enrolled in June 2023, and the last in December 2023. Data analysis is underway and is estimated to be completed by June 2024. A total of 32 participants were enrolled.

CONCLUSIONS

Most TAS brands have had limited application in clinical settings, and most studies have included healthy adults rather than people with AUD. TAS has the potential to enhance treatment outcomes in clinical alcohol treatment. The accuracy, acceptability, and feasibility of TAS for people with AUD in clinical settings need to be investigated. This is the first study to use TAS in specialized alcohol services with diagnosed AUD individuals currently receiving treatment from a south London alcohol service.

TRIAL REGISTRATION

ISRCTN Registry ISRCTN46845361; https://www.isrctn.com/ISRCTN46845361.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/57653.

摘要

背景

已经开发出用于客观、连续和可靠的酒精监测的可穿戴技术,即透皮酒精传感器(TAS)。它们可以戴在手腕或脚踝上,传感器紧贴皮肤,测量从皮肤中散发出来的汗液蒸气,以记录透皮酒精浓度(TAC)。以前的研究已经调查了可用 TAS 品牌的准确性和可接受性,但对其在患有酒精使用障碍(AUD)的人群中的使用研究甚少。

目的

本可行性随机对照试验旨在探讨使用 TAS 监测 AUD 治疗中个体的酒精摄入量的可行性、优势和局限性,有无条件管理(CM)以促进戒酒或低水平饮酒。

方法

目标样本量为 30 名(每组随机分配 15 名)。参与者将通过酒精服务处的海报广告招募。两组(对照组和 CM 组)在其常规治疗的背景下佩戴 TAS(BACtrack Skyn)2 周,每隔一个工作日与研究人员见面。在最后一次会议上,参与者将完成佩戴 TAS 后的体验调查。CM 组还将根据 TAS 测量的低或无酒精摄入量获得小额经济奖励。当 TAC 峰值低于设定阈值(<115.660 g/L)时,CM 组参与者将获得 5 英镑(6.38 美元)的优惠券。如果连续几天达到这一目标,将有财务奖金。研究人员将在每次研究访问时监测 TAC 的每一天,并根据设定的强化时间表向参与者分配经济奖励。

结果

第一名参与者于 2023 年 6 月入组,最后一名参与者于 2023 年 12 月入组。数据分析正在进行中,预计于 2024 年 6 月完成。共招募了 32 名参与者。

结论

大多数 TAS 品牌在临床环境中的应用有限,大多数研究都包括健康成年人,而不是 AUD 患者。TAS 有可能增强临床酒精治疗的治疗效果。TAS 对临床环境中 AUD 患者的准确性、可接受性和可行性需要进行研究。这是第一项在专门的酒精服务中使用 TAS 的研究,研究对象是目前正在接受伦敦南部酒精服务治疗的诊断为 AUD 的个体。

试验注册

ISRCTN 注册 ISRCTN46845361;https://www.isrctn.com/ISRCTN46845361。

国际注册报告标识符(IRRID):DERR1-10.2196/57653。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/830c/11325106/8aafe83af2cb/resprot_v13i1e57653_fig1.jpg

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