| CTRI Number |
CTRI/2025/09/094053 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
01/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral
Other (Specify) [Chatbot assisted intervention] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to test the efficacy of a virtual assistant/chatbot in tobacco and alcohol use patients compared to standard treatment. |
|
Scientific Title of Study
|
Process & patient outcomes with an AI enabled treatment
package for alcohol and nicotine use disorder
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aniruddha Basu |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, AIIMS Kalyani |
| Address |
All India Institute of Medical Sciences, Department of Psychiatry, Room 315, 3rd Floor Kalyani
Nadia
WEST BENGAL
741245
India
Nadia
WEST BENGAL
741245
India |
| Phone |
8968979239 |
| Fax |
|
| Email |
aniruddha.psy@aiimskalyani.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aniruddha Basu |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, AIIMS Kalyani |
| Address |
All India Institute of Medical Sciences, Department of Psychiatry, Room 315, 3rd Floor Kalyani
Nadia
WEST BENGAL
741245
India
WEST BENGAL
741245
India |
| Phone |
8968979239 |
| Fax |
|
| Email |
aniruddha.psy@aiimskalyani.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aniruddha Basu |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, AIIMS Kalyani |
| Address |
All India Institute of Medical Sciences, Department of Psychiatry, Room 315, 3rd Floor Kalyani
Nadia
WEST BENGAL
741245
India
WEST BENGAL
741245
India |
| Phone |
8968979239 |
| Fax |
|
| Email |
aniruddha.psy@aiimskalyani.edu.in |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research (ICMR) |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
New Delhi |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aniruddha Basu |
AIIMS Kalyani |
All India Institute of Medical Sciences, Kalyani
Nadia
WEST BENGAL
741245
India
Nadia
WEST BENGAL |
8968979239
aniruddha.psy@aiimskalyani.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of AIIMS Kalyani |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Control condition |
| Patients |
(1) ICD-10 Condition: F172||Nicotine dependence, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Active arm |
Active eDOSTHI intervention adjunct to standard treatment |
| Comparator Agent |
Placebo arm |
Disabling the interactive elements and retaining only the educational content |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
- 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 |
|
| ExclusionCriteria |
| Details |
- Severe medical or psychiatric illness as per self-report.
- Regular usage of drugs or alcohol (as per single question self-report) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
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. |
Baseline, 4 weeks, 26 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in GAD 7 and PHQ 9 scores |
Baseline, 4 weeks, 26 weeks |
|
|
Target Sample Size
|
Total Sample Size="440"
Sample Size from India="440"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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. |