| CTRI Number |
CTRI/2025/11/097608 [Registered on: 18/11/2025] Trial Registered Prospectively |
| Last Modified On: |
28/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effects of tobacco on people with mental illness who miss their medicines |
|
Scientific Title of Study
|
Evaluating the influence of tobacco use on medication non-compliance among psychiatric patients with common mental disorders |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Charishma G Kumble |
| Designation |
Student |
| Affiliation |
NGSM Institute of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice NGSM Institute of Pharmaceutical Sciences, Deralakatte, Mangaluru.
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7483786703 |
| Fax |
|
| Email |
charishmakumble@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Juno J Joel |
| Designation |
Associate Professor and Head |
| Affiliation |
NGSM Institute of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice NGSM Institute of Pharmaceutical Sciences, Deralakatte, Mangaluru.
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9480470727 |
| Fax |
|
| Email |
junojoel@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Juno J Joel |
| Designation |
Associate Professor and Head |
| Affiliation |
NGSM Institute of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice NGSM Institute of Pharmaceutical Sciences, Deralakatte, Mangaluru.
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9480470727 |
| Fax |
|
| Email |
junojoel@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| NITTE (Deemed to be University), NGSM Institute of Pharmaceutical Sciences
Deralakatte, Mangaluru, 575018 |
|
|
Primary Sponsor
|
| Name |
NITTE (Deemed to be University), NGSM Institute of Pharmaceutical Sciences |
| Address |
Deralakatte, Mangaluru, 575018 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrShishir Kumar |
Justice K S Hegde Charitable Hospital Deralakatte Mangalore |
Department of Psychiatry, Ground Floor, Deralakatte, Dakshina Kannada, Mangaluru, Karnataka
Dakshina Kannada
KARNATAKA |
9945520986
shishirkumar@nitte.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NGSM Institute of Pharmaceutical Sciences Institutional Ethics Committee(NGSMIPS-IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F40-F48||Anxiety, dissociative, stress-related, somatoform and other nonpsychotic mental disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Participants of either gender, aged between18-65 years.
Patients diagnosed with common mental health disorders such as depression, anxiety, stress, personality disorders, and obsessive-compulsive disorder (OCD) and receiving medications as part of their treatment.
Patients who use tobacco.
|
|
| ExclusionCriteria |
| Details |
Participants with severe mental disorders such as Schizophrenia, Bipolar disorders.
K/C/O Alcohol Use Disorder and Substance Use Disorder.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Tobacco use pattern
Nicotine dependence
Medication non-compliance |
Follow up: Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
30/11/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
INTRODUCTION: Tobacco use or consumption is a global health concern due to health risks associated with tobacco. Prevalence of tobacco use is significantly higher in patients with psychiatric disorders. Previous studies observed that patients who use tobacco were less adherent to their prescribed medication. NEED FOR THE STUDY: Previous research has shown higher tobacco use among patients with psychiatric disorders. However, the effect of tobacco use on medication compliance is not well known. With this background the present study focuses on evaluating the pattern of tobacco use, nicotine dependence among common mental disorder patients. OBJECTIVES OF THE STUDY: The present study aims to assess the pattern of tobacco use, nicotine dependence and to investigate the factors leading to tobacco use in lieu of medication among patients with common mental disorders METHODOLOGY: This study is a prospective observational study conducted at Justice K. S. Hegde Charitable Hospital in Mangaluru for six months. Time bound study will be considered from September 2025- February 2026. Ethical considerations ensure confidentiality and informed consent. Participants diagnosed with common mental disorders with the habit of using tobacco will be enrolled for the study and their craving intensity and medication compliance will be assessed. STATISTICAL ANALYSIS: Quantitative data will be expressed as mean± SD or median (IQR) and Qualitative data will be expressed as frequency and percentages. Chi-square test or Fisher’s exact test will be utilized. The p-value <0.05 will be considered statistically significant. SPSS software version 29 will be used for statistical analysis. ANTICIPATED OUTCOME: This study anticipates determining the pattern of tobacco use and nicotine dependence among common mental disorder patients. Additionally, it also aim to investigate the factors leading to tobacco use in lieu of medication. |