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临床试验/CTRI/2025/11/097608
CTRI/2025/11/097608尚未招募不适用

Evaluating the influence of tobacco use on medication non-compliance among psychiatric patients with common mental disorders

NITTE (Deemed to be University), NGSM Institute of Pharmaceutical Sciences1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年11月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
150
试验地点
1
主要终点
Nicotine dependence

研究概览

简要总结

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.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • 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.

排除标准

  • Participants with severe mental disorders such as Schizophrenia, Bipolar disorders.
  • K/C/O Alcohol Use Disorder and Substance Use Disorder.

结局指标

主要结局

Nicotine dependence

时间窗: Follow up: Baseline

Medication non-compliance

时间窗: Follow up: Baseline

Tobacco use pattern

时间窗: Follow up: Baseline

次要结局

未报告次要终点

研究者

发起方
NITTE (Deemed to be University), NGSM Institute of Pharmaceutical Sciences
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Charishma G Kumble

NGSM Institute of Pharmaceutical Sciences

研究点 (1)

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