| CTRI Number |
CTRI/2021/10/037366 [Registered on: 18/10/2021] Trial Registered Prospectively |
| Last Modified On: |
14/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Screening
Dentistry
Behavioral
Other (Specify) [Nicotine Replacement Therapy] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
ROLE OF NICOTINE GUMS, NICOTINE PATCHES AND BEHAVIOURAL COUNSELLING IN QUITTING TOBACCO HABIT |
|
Scientific Title of Study
|
EFFECTIVENESS OF NICOTINE REPLACEMENT THERAPY AND BEHAVIOURAL INTERVENTION IN TOBACCO CESSATION - A TERTIARY HOSPITAL BASED RANDOMISED CONTROLLED TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kumar Kuldeep |
| Designation |
Post Graduate Trainee |
| Affiliation |
S.C.B Dental College and Hospital |
| Address |
Department of Public Health Dentistry, S.C.B Dental College and Hospital, Mangalabag, Cuttack
2nd Floor, Department of Public Health Dentistry, S.C.B Dental College and Hospital
Cuttack
ORISSA
753007
India |
| Phone |
9438222603 |
| Fax |
|
| Email |
kkuldeep583@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Utkal Keshari Mohanty |
| Designation |
Associate Professor |
| Affiliation |
S.C.B Dental College and Hospital |
| Address |
Department of Public Health Dentistry, S.C.B Dental College and Hospital, Mangalabag, Cuttack
Tobacco Research Cell, S.C.B Dental College and Hospital
Cuttack
ORISSA
753007
India |
| Phone |
9437953285 |
| Fax |
|
| Email |
utkalcommunity@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Utkal Keshari Mohanty |
| Designation |
Associate Professor |
| Affiliation |
S.C.B Dental College and Hospital |
| Address |
Department of Public Health Dentistry, S.C.B Dental College and Hospital, Mangalabag, Cuttack
Tobacco Research Cell, S.C.B Dental College and Hospital
Cuttack
ORISSA
753007
India |
| Phone |
9437953285 |
| Fax |
|
| Email |
utkalcommunity@gmail.com |
|
|
Source of Monetary or Material Support
|
| Cipla Pharmaceutical Company |
|
|
Primary Sponsor
|
| Name |
Cipla Pharmaceutical Company |
| Address |
Company Secretary
Cipla Limited Cipla House,
Peninsula Business Park, Ganpatrao Kadam Marg,
Lower Parel, Mumbai-400 013 |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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 Kumar Kuldeep |
Tobacco Cessation Center, S.C.B Dental College |
Room no-09, Tobacco Cessation Center, Department of Public Health Dentistry, New Annex Building, S.C.B Dental College and Hospital, Mangalabag, 753007
Cuttack
ORISSA |
9438222603
kkuldeep583@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, S.C.B Dental College and Hospital, Cuttack, Odisha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Individuals more than 18years of age using smoke or smokeless form of tobacco with high or moderate dependency based on modified Fagerstrom scoring criteria |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
behavioural intervention |
Tobacco cessation counselling for a period of 12 months |
| Intervention |
Nicotine gum and behavioural intervention |
Nicotine gum for a maximum period of 12 weeks depending on tobacco consumption along with 12 months behavioural counselling |
| Intervention |
Nicotine patch and Behavioural intervention |
Nicotine patch therapy for maximum period of 12 weeks depending on tobacco consumption along with 12 months behavioural counselling |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Individuals more than 18years of age using smoke or smokeless form of tobacco with high or moderate dependency based on modified Fagerstrom scoring criteria and residing within 100Km from the institution. |
|
| ExclusionCriteria |
| Details |
Tobacco users with unstable angina, severe cardiac arrhythmia, recent acute myocardial
infarction or cerebrovascular accident in preceding 3 months, pregnant and breast feeding
women and tobacco users with a previous history of failure to NRT will be excluded from the
study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| tobacco abstinence rate |
6 months and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| comparing effect of different therapies on cessation of smoking and smokeless tobacco. |
6 months and 12 months |
| the oral health status |
baseline, 3 months, 6 months & 12 months |
| tobacco dependency |
baseline, 3 months, 6 months and 12 months |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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 4 |
|
Date of First Enrollment (India)
|
18/10/2021 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Tobacco use is a leading cause of preventable
deaths all over the world and worldwide
there are nearly1.2 billion users of nicotine and tobacco products causing more
than 5million deaths per year. Across studies, it has been found that the
morbidity and mortality associated with tobacco use are substantially reduced
by its complete cessation. The rationale of nicotine replacing therapy for nicotine
dependence treatment is based on theory of harm reduction by making it easier to
replace the nicotine obtained from tobacco thereby providing nicotine mediated
neuropharmacological effect. As per Global Adult
Tobacco Survey India (GATS 2, 2016-17) 42.4% of men, 14.2% of
women and 28.6% (266.8 million) of all adults use tobacco (smoked and/or
smokeless tobacco), while in Odisha 45.6% of adults ( >15 years) are tobacco
users from which 2.8% are smoked, 38.6%
are smokeless and 4.3% are both smoked and smokeless tobacco users. Despite of such prevalence of tobacco use in
India, very few studies have been done for tobacco cessation using Nicotine
replacement therapy as an intervention and not a single such study has yet been
done in Odisha. |