| CTRI Number |
CTRI/2018/03/012867 [Registered on: 26/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
24/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Other (Specify) [Nicotine Replacement Therapy (chew gum)] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of Behavioral Counselling with Nicotine Gum versus Behavioral Counselling alone for quitting tobacco usage among patients at a Tobacco Cessation Clinic in Delhi. |
|
Scientific Title of Study
|
Effectiveness of Behavioral Counselling with Nicotine Gum versus Behavioral Counselling among patients visiting Tobacco Cessation Clinic in Delhi: a Randomized Clinical Trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neetu |
| Designation |
Post Graduate Student |
| Affiliation |
Maulana Azad Institute of Dental Sciences |
| Address |
Department of Public Health Dentistry ,Maulana Azad Institute of Dental Sciences, MAMC campus
New Delhi
DELHI
110002
India |
| Phone |
7838230205 |
| Fax |
|
| Email |
neetusrdc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vikrant Mohanty |
| Designation |
Associate Professor and Head Of Department , Public Health Dentistry |
| Affiliation |
Maulana Azad Institute of Dental Sciences |
| Address |
Department of Public Health Dentistry ,Maulana Azad Institute of Dental Sciences, MAMC campus
New Delhi
DELHI
110002
India |
| Phone |
9654700983 |
| Fax |
|
| Email |
vikrantmohanty@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Neetu |
| Designation |
Post Graduate Student |
| Affiliation |
Maulana Azad Institute of Dental Sciences |
| Address |
Department of Public Health Dentistry ,Maulana Azad Institute of Dental Sciences, MAMC campus
New Delhi
DELHI
110002
India |
| Phone |
7838230205 |
| Fax |
|
| Email |
neetusrdc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Public Health Dentistry
Maulana Azad Institute of Dental Sciences(Govt. of NCT Delhi)
2, B.S. Z-Marg, MAMC Campus
New Delhi-11000 |
|
|
Primary Sponsor
|
| Name |
Dr Neetu |
| Address |
Department of public health dentistry ,Maulana Azad Institute of Dental Sciences, MAMC campus
New Delhi
DELHI
110002
India |
| Type of Sponsor |
Other [Personal] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Department of Public Health DentistryMaulana Azad Institute of Dental Sciences |
Department of Public Health Dentistry
Maulana Azad Institute of Dental Sciences(Govt. of NCT Delhi)
2, B.S. Z-Marg, MAMC Campus
New Delhi-11000 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Neetu |
Maulana Azad Institute Of Dental Sciences |
Ground floor, Tobacco Cessation Clinic (TCC)
Central
DELHI |
7838230205
neetusrdc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAIDS Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F172||Nicotine dependence, tobacco users, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1.Behavioral counselling, Nicotine Replacement Therapy |
NRT Dosage
2mg and 4 mg depending upon the patients tobacco usage.
Route of administration - Oral
Total duration- 12 weeks.
Schedule-
For first 6 weeks- One Gum every 1-2 hours
For 6- 10 weeks - One Gum every 2-4 hours
For 10-12 weeks - One Gum every 4-8 hours or when craving occurs. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. A daily smoker/smokeless/mixed form of tobacco user.
2. Patients reporting to the TCC and found to be tobacco users.
3. Those who will give informed consent and are able to read and write local language.
4. Patients who have medium nicotine dependence score as per Fagerstrom scale for smoking and Modified Fagerstrom scale for smokeless tobacco.
|
|
| ExclusionCriteria |
| Details |
1. Patient not willing to participate, uncooperative and are edentulous/having TMJ problems/chewing difficulties and any dental emergencies.
2. Patients who are medically compromised and have diseases which are contraindications for NRT use.
3. Patients/Tobacco users who have not participated in any trial or intervention related to tobacco cessation.
4. Patients who report past usage of NRT (with or without prescription) and have experienced side effects.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effectiveness of two methods on the basis of quit status: quit, reduction and status quo. |
1st week,2nd week, 3rd week, 3rd month, 6th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Sociodemographic and other related factors, Nicotine dependence, Oral health status and Tobacco related Health Literacy. |
1st week,2nd week, 3rd week, 3rd month, 6th month |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/07/2017 |
| Date of Study Completion (India) |
06/05/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
06/05/2018 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Tobacco related diseases have emerged as a major public health in India.Nearly 3000 chemical constituents in smokeless tobacco and about 4000 chemicals in tobacco smoke have been identified of which many are known carcinogens.According to World Health Organization the current smokers across the world are 1.3 billion and 5 million in the world die annually due to smoking.Nearly two-thirds of the world’s tobacco users live in just 10 countries and >40% live in just 2 countries,that is, China and India. India is currently the second largest consumer of tobacco products in the world.Problems related to tobacco in India are very complex because of the relationship between huge burden of tobacco related diseases, deaths, economic interests and also cultural beliefs. Unfortunately, very few people in India quit tobacco use. Lack of awareness of harm, ingrained cultural attitudes and lack of support for cessation maintains tobacco use in the community. The significant addictive property of nicotine makes quitting difficult and relapse common. Health professionals have received little training, and very few thus carry out proper assessments and interventions among tobacco users. Evidence from the developed countries suggests that brief interventions delivered by diverse health professionals are effective in tobacco cessation. Combining pharmacological approaches with behavioral counselling produces better results than a single strategy. Given the high global morbidity and mortality from tobacco use in India ,there is a need to develop evidence-based, cost-effective interventions for both smoking and smokeless tobacco. Hence,the present study is planned among tobacco users visiting Tobacco Clinic Clinic to check the effectiveness of tobacco cessation interventions. |