| CTRI Number |
CTRI/2024/06/068508 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
06/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Motivational interviewing vs Nicotine replacement therapy vs Combination for Smoking Cessation |
|
Scientific Title of Study
|
Effectiveness of three different tobacco smoking cessation interventions among patients visiting a dental institute in Bangalore : A Randomized Clinical Trial |
| 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 Anagha Reji |
| Designation |
Senior Lecturer |
| Affiliation |
Krishnadevaraya College of Dental Science & Hospital |
| Address |
Department of Public health dentistry,
Krishnadevaraya College of Dental Science & hospital,
Krishnadevarayanagar, Yelahanka,Bangalore 560057
Bangalore
KARNATAKA
560097
India |
| Phone |
9742739833 |
| Fax |
|
| Email |
anaghareji1996@outlook.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anagha Reji |
| Designation |
Senior Lecturer |
| Affiliation |
Krishnadevaraya College of Dental Science & Hospital |
| Address |
Department of Public health dentistry,
Krishnadevaraya College of Dental Science & hospital,
Krishnadevarayanagar, Yelahanka,Bangalore 560057
Bangalore
KARNATAKA
560097
India |
| Phone |
9742739833 |
| Fax |
|
| Email |
anaghareji1996@outlook.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anagha Reji |
| Designation |
Senior Lecturer |
| Affiliation |
Krishnadevaraya College of Dental Science & Hospital |
| Address |
Department of Public health dentistry,
Krishnadevaraya College of Dental Science & hospital,
Krishnadevarayanagar, Yelahanka,Bangalore 560057
Bangalore
KARNATAKA
560097
India |
| Phone |
9742739833 |
| Fax |
|
| Email |
anaghareji1996@outlook.com |
|
|
Source of Monetary or Material Support
|
| Cipla health Ltd
Art Guild House, B-Wing, 4th Floor, Phoenix Market city, Kurla West, Mumbai, Maharashtra 400070 |
|
|
Primary Sponsor
|
| Name |
Cipla health Ltd |
| Address |
Art Guild House, B-Wing, 4th Floor, Phoenix MarketCity, Kurla West, Mumbai-400070 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Anagha Reji |
Krishnadevaraya College of dental Science & hospital |
Sir MVIT campus, krishnadevaraya college of dental sciences and hospital, Krishndevarayangar, Hunasamaranhalli, Yelahanka, Bengaluru, Karnataka 562157
Bangalore
KARNATAKA |
09742739833
dr.anaghareji@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Krishnadevaraya College of Dental Sciences & Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
people who are tobacco smokers |
| Patients |
(1) ICD-10 Condition: X838||Intentional self-harm by other specified means, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Motivational interviewing |
In this group patients received motivational interviewing. Motivational interviewing (MI) is a brief, client-centred approach focused on resolving ambivalence regarding quitting and increasing self-efficacy for change. MI uses a non-judgmental, directive, and supportive therapeutic style that emphasizes personal responsibility for making decisions about change and often incorporates personalized feedback, designed to correct normative misperceptions, and heighten awareness of personally-relevant consequences of smoking.
Motivational interviewing uses several communication methods, such as questionnaire and affirming and reflective listening, to express empathy, develop discrepancy, resistance, and support self-efficacy.
these interventions will be provided for a duration of 3 months in which the frequency at which patients will be called back for follow up is after every 2 week |
| Comparator Agent |
Motivational Interviewing + Nicotine Replacement Therapy (Nicotine Gums) |
In this group, the patients received a combination of both Nicotex nicotine gums 4mg and Motivational interviewing
these interventions will be provided for a duration of 3 months in which the frequency at which patients will be called back for follow up is after every 2 week |
| Comparator Agent |
Nicotine Replacement Therapy (Nicotine Gums) - 4mg |
Nicotex nicotine gums of 4mg were given to the patients as a form of NRT. The participants were instructed not to chew the gum like confectionary gums, but intermittently chew and park until a tingling feeling was experienced. It was advised to hold the gum in the mouth for approximately for 30 minutes, or as needed to release its nicotine.
Nicotine gums 4mg was selected as it was proven to be more effective in highly dependent smokers than 2mg in previous studies.
these interventions will be provided for a duration of 3 months in which the frequency at which patients will be called back for follow up is after every 2 week |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Outpatients visiting hospital wit smoking habit
2. Fagerstrom score of more than 6
3. Patients willing to quit tobacco |
|
| ExclusionCriteria |
| Details |
1. Patients having terminal illness/Any other medical illness.
2. Patients using smokeless type of tobacco
3. Pregnancy
4. Patients under psychiatric care
5. Previous history of alcohol or drug abuse
6. History of hypersensitive reactions toward nicotine or Menthol
7. Patients who were not willing to quit tobacco
8. Patients who were not willing to take part in the study.
9. Patients having TMJ dysfunction.
10. Patients wearing dentures |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduced Fagaerstorm value and reduced carbonmonoxide meter levels in lungs of smokers |
baseline, 2 weeks after the quit date, 4weeks after the quit date, 6weeks after the quit date, 8 weeks after the quit date, 10 weeks after the quit date, 12 weeks after the quit date |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| overall reduction in smoking leading to healthier adn quality improved life |
in period of three 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)
|
17/06/2024 |
| 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="0"
Months="3"
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 uses and addiction have existed for centuries and, there surely was resultant
death and disease . Evaluations indicate cigarette smoking causes the death of
approximately five million people worldwide every year . A decrease in the
prevalence of tobacco consumption can be effectively done through a prolonged
approach called tobacco cessation, which includes various methods like
pharmacological and non-pharmacological methods.
One such non-pharmacological approach is Motivational Interviewing.
Motivational interviewing is a type of counselling that can be used to help people to
stop smoking. It aims to help people explore the reasons that they may feel unsure
about quitting and find ways to make them feel more willing and able to stop
smoking. The most commonly used pharmacological intervention in smoking
cessation is nicotine replacement therapy (NRT), which is frequently available over
the counter (OTC). It allows the absorption of nicotine through the buccal mucosa and
reduces the motivation to consume tobacco and, the physiological and psychomotor
withdrawal symptoms through the delivery of nicotine. A randomized clinical trial is to be conducted among 18 – 50 year smokers using
a smoking form of tobacco products at Tobacco cessation cell in a dental institute in
Bangalore. This randomized clinical trial is conducted to assess the effectiveness of
three different smoking tobacco cessation interventions by assessing the reduction of
carbon monoxide levels in smokers over three months. |