| CTRI Number |
CTRI/2019/08/021008 [Registered on: 30/08/2019] Trial Registered Prospectively |
| Last Modified On: |
29/08/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Behavioral |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of NRT and Video assisted NRT on tobacco cessation and addiction level among adults attending Deaddiction Clinic AIIMS Rishikesh. |
|
Scientific Title of Study
|
A Randomized Controlled Trial to assess the effectiveness of Nicotine Replacement Therapy and Video Assisted Nicotine Replacement Therapy on Tobacco Cessation and Addiction Level among adults attending Deaddiction Clinic at AIIMS, Rishikesh, Uttarakhand. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hoineiting Rebecca Haokip |
| Designation |
M.Sc Nursing 1st year. |
| Affiliation |
All India Institute of Medical Sciences, College of Nursing |
| Address |
Department of College of Nursing(mental health nursing)room no.357 AIIMS Rishikesh.
Department of College of Nursing(mental health nursing)room no.357 AIIMS Rishikesh.
Dehradun
UTTARANCHAL
249203
India |
| Phone |
7060736360 |
| Fax |
|
| Email |
cayceehaokip@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Kumar |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences Rishikesh College of Nursing. |
| Address |
Dr. Rajesh Kumar
Assistant Professor
Department of college of nursing(mental health nursing)
All India Institute of Medical Sciences, Rishikesh(AIIMS)virbhadra marg pashulok .
Dr. Rajesh Kumar
Assistant Professor
Department of College of nursing(mental health nursing)
All India Institute of Medical Sciences, Rishikesh(AIIMS), virbhadra marg pashulok .
Dehradun
UTTARANCHAL
249203
India |
| Phone |
7055911523 |
| Fax |
|
| Email |
rajeshrak61@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Hoineiting Rebecca Haokip |
| Designation |
M.Sc Nursing 1st year |
| Affiliation |
All India Institute of Medical Sciences Rishikesh College of Nursing. |
| Address |
Department of College of Nursing(mental health nursing)room no.357 AIIMS Rishikesh.
Department of College of Nursing(mental health nursing)room no.357 AIIMS Rishikesh.
Dehradun
UTTARANCHAL
249203
India |
| Phone |
7060736360 |
| Fax |
|
| Email |
cayceehaokip@gmail.com |
|
|
Source of Monetary or Material Support
|
| De-addiction clinic, All India Institute of Medical Sciences Rishikesh Hospital Department of psychiatry virbhadra marg pashulok uttarakhand 249203. |
|
|
Primary Sponsor
|
| Name |
Hoineiting Rebecca Haokip |
| Address |
MSC Nursing 1 Year AIIMS Rishikesh Uttarakhand 249203 |
| Type of Sponsor |
Other [Self Funded ] |
|
|
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 |
| Hoineiting Rebecca Haokip |
All India Institute of Medical Sciences Rishikesh (AIIMS) |
De-addiction clinic, Department of Psychiatry Room no.
Dehradun
UTTARANCHAL |
7060736360
cayceehaokip@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE AIIMS RISHIKESH |
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 |
Nicotine replacement therapy along with standard explanation of psychiatrist |
Psychiatrist will prescribe nicotine replacement therapy along with standard explanation to use it to control group.
nicotine replacement therapy:
1.nicotine gum (orally)2mg/4mg according to consumption of tobacco
2.nicotine patches-7mg /14 mg(transdermal)
3.nicotine lozengs(orally)
the frequency of therapy depends on how much amount the client is consuming.
the duration of therapy will be according to Doctors presciption.
|
| Intervention |
Video assisted nicotine replacement therapy |
A short film (4-5 mints) on tobacco epidemic, chemical composition of tobacco, complication/health hazards,health benefits of quitting tobacco and prevention will be shown to intervention arm along with nicotine replacement therapy
nicotine replacement therapy:
1.nicotine gum (orally)2mg/4mg according to consumption of tobacco
2.nicotine patches-7mg /14 mg(transdermal)
3.nicotine lozengs(orally)
the frequency of therapy depends on how much amount the client is consuming.
the duration of therapy will be according to Doctors presciption.
|
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects age group 19-55 years who were taking any form of tobacco (smoking/smokeless).
2. Subjects consuming 5-10 cigarettes per days.
3. Subjects taking any form of Tobacco since the last 3-5 years.
4. Subjects who are interested to being involved in the study.
5. Subjects who understand English and Hindi language.
6. Subjects not willing to quit but who were interested in reducing smoking levels.
7. Subjects who are interested in using nicotine gum after prescription of Psychiatrists.
|
|
| ExclusionCriteria |
| Details |
1. Pregnant, intending or becoming pregnant or nursing mothers.
2. Have medical conditions that would make participation medically hazardous (such as Respiratory disease, cardiovascular disease and renal disease).
3. Subjects under the treatment of Psychiatric Disorders.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Tobacco cessation status: Tobacco cessation level will be measured by using Importance Readiness and Confidence scale (IRC) at 2 weeks and 4 weeks in experimental and control group.
2. Addiction level: Addiction level will be measured by using Fagerstrom Tolerance Nicotine Dependence Scale(FTNDS) and Fagerstrom Tolerance Nicotine dependence scale (smokeless) at 2 weeks and 4 weeks in experimental and control group.
|
2 weeks and 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Urine Cotinine level |
2 weeks and 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="190"
Sample Size from India="190"
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)
|
30/09/2019 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
The data will be published at the end pf trail; No plan for interim analysis |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A randomised control trial is planned to see the effect of nicotine replacement therapy vs video assisted nicotine replacement therapy in tobacco users on tobacco cessation and addiction status addiction status among adults visiting at de-addiction centre of AIIMS Rishikesh. A sample size is calculated for the study and data will be analysed after the end of trail. |