| CTRI Number |
CTRI/2025/04/085862 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
28/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To understand the Efficacy and safety of Varenicline, Bupropion and Nicotine Replacement Therapy for Smokeless Tobacco Cessation in India: A Randomized Controlled Trial |
|
Scientific Title of Study
|
Evaluating the Effectiveness and safety of Varenicline over Bupropion and Nicotine Replacement Therapy for Smokeless Tobacco Cessation in India: A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| RD/AIIMS/Pat/2024/RAC/72 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sambhu Prasad |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences Patna Bihar |
| Address |
Department of Psychiatry AIIMS Patna
Phulwarisharif AIIMS Patna
Patna
BIHAR
801507
India |
| Phone |
08427016592 |
| Fax |
|
| Email |
sambhu3011@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sambhu Prasad |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences Patna Bihar |
| Address |
Department of Psychiatry AIIMS Patna
Phulwarisharif AIIMS Patna
BIHAR
801507
India |
| Phone |
08427016592 |
| Fax |
|
| Email |
sambhu3011@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sambhu Prasad |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences Patna Bihar |
| Address |
Department of Psychiatry AIIMS Patna
Phulwarisharif AIIMS Patna
BIHAR
801507
India |
| Phone |
08427016592 |
| Fax |
|
| Email |
sambhu3011@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Psychiatry AIIMS Patna, Phulwarisharif, Patna, Bihar, India. Pin- 801507 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Patna |
| Address |
Department of Psychiatry AIIMS Patna, Phulwarisharif, Patna, Bihar, India. Pin- 801507 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sambhu Prasad |
All India Institute of Medical Sciences Patna |
Department of Psychiatry AIIMS Patna Phulwarisharif Patna Bihar Pin 801507
Patna
BIHAR |
8427016592
sambhu3011@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee AIIMS Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F172||Nicotine dependence, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bupropion group |
Tab Bupropion standard dose as per clinical practice guideline
and manual guided psychosocial intervention (weekly session for 12 week) |
| Comparator Agent |
Nicotine Replacement Treatment group |
Nicotine Replacement Treatment as per clinical practice guideline plus manual guided psychosocial intervention (weekly session for 12 week) |
| Intervention |
Varenicline group |
Tad Varnicline standard dose shedule as per guideline plus manual guided psychosocial intervention (weekly session for 12 week) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Use of smokeless tobacco each day for the past year (confirmed with urinary cotinine assessment greater than or equal to 50 ng/ml)
The age over 18 years
Residing within 120 KM of Patna |
|
| ExclusionCriteria |
| Details |
Current cigarette use which is confirmed with breath carbon monoxide level greater than 10 ppm
Current or planned use of tobacco cessation treatment
Current use of cocaine, marijuana, or opioids or current consumption of greater than or equal to 25 alcoholic drinks per week
Current or recent use of psychiatric, pain, or asthma medications
Current pregnancy or lactation
History or current diagnosis of psychosis, schizophrenia, bipolar disorder, or suicidality
Current diagnosis of depression; diagnosis of cancer, heart disease, or HIV or AIDS in past 6 months
History of epilepsy or seizures
History or diagnosis within the last 6 months of abnormal heart rhythms and or tachycardia which is greater than 100 beats per min
History or current diagnosis of chronic obstructive pulmonary disease, cardiovascular disease, heart attack in the last 6 months, and uncontrolled hypertension in which systolic blood pressure greater than 150 or diastolic blood pressure greater than 90
History of kidney or liver failure
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the efficacy of Varenicline, Bupropion, and Nicotine Replacement Therapy (NRT) in achieving smokeless tobacco cessation among users in India, measured by self-reported and biochemically verified abstinence rates at the end of treatment and during follow-up periods
|
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the cessation success rates among smokeless tobacco users treated with Varenicline, Bupropion, and NRT, considering both the end of treatment and follow-up periods, to determine the sustainability of cessation.
|
12 weeks |
To assess the impact of medication adherence rates on the effectiveness of Varenicline, Bupropion, and NRT in facilitating tobacco cessation, identifying adherence as a potential mediator of treatment success.
|
12 weeks |
To compare the incidence of side effects and serious adverse events among smokeless tobacco users undergoing treatment with Varenicline, Bupropion, and NRT to assess the safety profiles of these pharmacotherapies.
|
12 weeks |
To investigate the effect of Varenicline, as compared to Bupropion and NRT, on reducing cravings for smokeless tobacco and enhancing the likelihood of recovery to abstinence following a lapse, highlighting its potential advantages in managing relapse.
|
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/05/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - Under the permission from Ethical committee of the Institute
- For how long will this data be available start date provided 15-05-2026 and end date provided 14-04-2027?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Smokeless tobacco (SLT) use, a form of tobacco consumed without combustion/burning, has become a global health issue with about 350 million users, maximally seen in the South-East Asian Region. Its use is associated with a myriad of adverse effects. Around 40% of the total economic cost because of tobacco use occurs in low- and middle-income countries (LMICs), and 25% is accounted for by Brazil, Russia, India, and China alone. India is the second largest consumer (current use- 48% males, 20% females; 275 million adults), and third largest producer of tobacco in the world. It has one of the highest mortality rates related to tobacco (~0.9 million of the 6 million annual deaths globally). The treatment gap for tobacco use in India is as high as 92%.The behavioral interventions have been found to be efficacious for reducing smokeless tobacco dependence when tested in clinical trials (quit rates in such trials rarely exceed 15%). Clinical trials of nicotine replacement therapies (NRTs) have shown efficacy on short-term cessation. Further, clinical trials testing other NRTs and bupropion have not yielded positive results. In contrast, a large placebo controlled trial in Scandinavia found that varenicline was efficacious for smokeless tobacco dependence , and a pilot trial in the northern India reported preliminary support for an additional large clinical trial evaluation of varenicline for smokeless tobacco users in the India considering the potential lower effect size and lower medication adherence rates in this population.iven that varenicline is relatively more effective for treating tobacco smoking than NRT and bupropion and that varenicline significantly reduces craving to use smokeless tobacco, varenicline may be efficacious for treating smokeless tobacco dependence in India
|