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CTRI Number  CTRI/2024/05/067200 [Registered on: 10/05/2024] Trial Registered Prospectively
Last Modified On: 10/05/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Trial to assess efficacy of Nurse delivered brief interventions for tobacco use disorders. 
Scientific Title of Study   Efficacy of nurse delivered brief interventions for tobacco use disorders: A multispecialty open label randomized control 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  Santanu Nath 
Designation  Associate Professor (Department of Psychiatry) 
Affiliation  All India Institute of Medical Sciences- Deoghar 
Address  Room No: 5, Out-patient Department, 1st Floor, D-Block, Department of Psychiatry, All India Institute of Medical Sciences- Deoghar Jharkhand

Deoghar
JHARKHAND
814152
India 
Phone  9337434349  
Fax    
Email  santanu.psychiatry@aiimsdeoghar.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Santanu Nath 
Designation  Associate Professor (Department of Psychiatry) 
Affiliation  All India Institute of Medical Sciences-Deoghar 
Address  Room No: 5, Out-patient Department, 1st Floor, D-Block, Department of Psychiatry, All India Institute of Medical Sciences-Deoghar Jharkhand

Deoghar
JHARKHAND
814152
India 
Phone  9337434349  
Fax    
Email  santanu.psychiatry@aiimsdeoghar.edu.in  
 
Details of Contact Person
Public Query  
Name  Santanu Nath 
Designation  Associate Professor 
Affiliation  All India Institute of Medical Sciences-Deoghar 
Address  Room No: 5, Out-patient Department, 1st Floor, D-Block, Department of Psychiatry, All India Institute of Medical Sciences-Deoghar Jharkhand

Deoghar
JHARKHAND
814152
India 
Phone  9337434349  
Fax    
Email  santanu.psychiatry@aiimsdeoghar.edu.in  
 
Source of Monetary or Material Support  
Indian Council of Medical Research. Address: V. Ramalingaswami Bhawan, P.O. Box No. 4911 Ansari Nagar, New Delhi - 110029, India 
 
Primary Sponsor  
Name  Indian Council of Medical Research 
Address  V. Ramalingaswami Bhawan, P.O. Box No. 4911 Ansari Nagar, New Delhi - 110029, India 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Santanu Nath  All India Institute of Medical Sciences-Deoghar  Room No-5, Out-patient Department, 1st Floor, D-Block, Department of Psychiatry, AIIMS-Deoghar, Jharkhand
Deoghar
JHARKHAND 		 9337434349

santanu.psychiatry@aiimsdeoghar.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC of AIIMS-Deoghar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F172||Nicotine dependence,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Adjunct nurse delivered brief intervention  A structured manual based screening and brief intervention delivered by Nurses which will include harms related to tobacco, benefits of quitting, setting a quit date, techniques to manage craving and withdrawal, handling lapses and relapses (overall duration 5-10 minutes). This is in addition to (adjuvant) standard treatment. The intervention will be a single time intervention with a duration of 5-10 mins. 
Comparator Agent  Doctor delivered Standard treatment   This includes 5-A model providing nicotine replacement therapy and anti-craving agents as may deemed necessary. This will be a single time event with a duration of 5-10 mins. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients clinically diagnosed with tobacco use disorders according to DSM-5 (19).
2. Patients aged 18-60 years of either sex.
3. Patients who are current tobacco users (using once in last 1 week).
4. Patients giving voluntary written consent for participation. 
 
ExclusionCriteria 
Details  1. Presence of comorbid other substance use disorder in dependence pattern.
2. Critically ill patients or patients in acute emergency
3. Patients already on treatment for tobacco use disorders 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Proportion of patients abstinent after intervention (as measured by negative urine cotinine levels)  Baseline & 28th Day 
 
Secondary Outcome  
Outcome  TimePoints 
• Proportion of patients reduced tobacco use after intervention
• Proportion of abstinent or reduced tobacco in each specialty 		 Baseline, 14th Day & 28th Day 
 
Target Sample Size   Total Sample Size="550"
Sample Size from India="550" 
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)   21/05/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  By emailing the principal investigator as santanu.psychiatry@aiimsdeoghar.edu.in

  6. For how long will this data be available start date provided 25-10-2025 and end date provided 25-10-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
Background: Treatment gap for tobacco use disorders is as high as 92%. Training nursing professionals to deliver brief interventions can help is reducing the treatment gap. Evidence for efficacy of such interventions is absent in Indian context.
Novelty: Generating evidence for nurse delivered brief interventions for tobacco use disorders in Indian context will have public health implications.
Objective: The primary objective is to compare the abstinent rates between two groups. The secondary objective is to compare the reduction in tobacco use between the groups and also, to compare the abstinence rates and reduction in the tobacco use among the individual specialties for smokeless and smoking tobacco.
Methods: A prospective, open label, parallel arm, randomized clinical trial in patients with tobacco use disorder attending the OPD of the AIIMS Deoghar in all the participating departments of this study (6 departments), over a period of 24 months. 550 patients with tobacco use disorders, who are currently either smoking or using smokeless tobacco in the last 1 week and fulfilling the inclusion and exclusion criterion will be recruited for the study. Participants will be randomized into group 1 (treatment as usual) and group 2 (treatment as usual with nurse delivered brief intervention). Tobacco use patterns, craving, motivation to quit, urine cotinine level will be assessed at baseline and 4 weeks.
Expected outcome: We expect that proportion of patients abstinent (as measured by negative urine cotinine levels) will be higher among the participants receiving the nurse delivered brief intervention group compared to treatment as usual only group.
 
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