跳至主要内容
临床试验/CTRI/2025/09/094053
CTRI/2025/09/094053尚未招募不适用

Process & patient outcomes with an AI enabled treatment package for alcohol and nicotine use disorder

Indian Council of Medical Research1 个研究点 分布在 1 个国家目标入组 440 人开始时间: 2026年1月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
440
试验地点
1
主要终点
The expected outcome of the study will be a significant reduction in tobacco usage from the baseline, reflected in self-report, psychological scales, level of carbon monoxide and other

研究概览

简要总结

Tobacco use and dependence pose a substantial public health challenge in our country. Thus, there is a need to enable patients who wish to quit tobacco use by linking them to treatment services and guiding them through the treatment course. Moreover, there is a well-established association between tobacco use and other substances. This study proposes using  artificial intelligence (AI) methods to increase the reach and ease of treatment for tobacco cessation.

The purpose of this study is to carry out a randomised controlled trial to evaluate a language compatible and culturally-adapted mobile application (Electronic means of Decreasing Overuse of Substance like Tobacco- a Health Promoting Intervention: eDOSTHI) that can help patients with tobacco use to obtain medical advice and achieve abstinence.

研究设计

研究类型
Interventional
分配方式
Randomized

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • 18-65 years of either sex.
  • Used more than once tobacco in any form (smoking or smokeless) in the last one month.
  • Fagerstrom test for Nicotine dependence (FTND) moderate and severe (more than 6).
  • Accepts help to quit smoking next month.
  • Owns a mobile smart phone/electronic device running under Android OS and subscribing to an internet connection and services under 4G/5G technology and with the ability to install an application.
  • Understands spoken and written English or Bengali language, and is able to communicate electronically.

排除标准

  • Severe medical or psychiatric illness as per self-report.
  • Regular usage of drugs or alcohol (as per single question self-report).

结局指标

主要结局

The expected outcome of the study will be a significant reduction in tobacco usage from the baseline, reflected in self-report, psychological scales, level of carbon monoxide and other

时间窗: Baseline, 4 weeks, 26 weeks

biochemical parameters.

时间窗: Baseline, 4 weeks, 26 weeks

次要结局

  • Change in GAD 7 and PHQ 9 scores(Baseline, 4 weeks, 26 weeks)

研究者

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

Dr Aniruddha Basu

All India Institute of Medical Sciences, AIIMS Kalyani

研究点 (1)

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