Skip to content

A clinical trial to test the efficacy of a virtual assistant/chatbot in tobacco and alcohol use patients compared to standard treatment.

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/094053
Enrollment
440
Registered
2025-09-01
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F172- Nicotine dependence

Interventions

Intervention1: Active arm: Active eDOSTHI intervention adjunct to standard treatment Control Intervention1: Placebo arm: Disabling the interactive elements and retaining only the educational content

Sponsors

Indian Council of Medical Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: - 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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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 biochemical parameters.Timepoint: Baseline, 4 weeks, 26 weeks

Secondary

MeasureTime frame
Change in GAD 7 and PHQ 9 scoresTimepoint: Baseline, 4 weeks, 26 weeks

Countries

India

Contacts

Public ContactDr Aniruddha Basu

All India Institute of Medical Sciences, AIIMS Kalyani

aniruddha.psy@aiimskalyani.edu.in8968979239

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026