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A Study on Visual Vs. Standard Nicotine Replacement Therapy for Smokeless Tobacco Users

A Pilot Randomized Controlled Trial Comparing Visually Aided Nicotine Replacement Therapy and Standard Nicotine Replacement Therapy In Smokeless Tobacco Users. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/070901
Enrollment
90
Registered
2024-07-19
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F172- Nicotine dependence

Interventions

Intervention1: Visually aided nicotine replacement therapy: The group will receive NRT with a video film of about 5 minutes duration with themes covered on tobacco epidemiology, health hazards of toba

Sponsors

Dr Aman Rajput
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Adult patients having age between 18 years to 55 years. 2.Patients willing to give consent for the study. 3.Patients fulfilling the diagnosis of tobacco dependence as per ICD 10 17.24 criteria. 4.Patients having availability of smartphone.

Exclusion criteria

Exclusion criteria: 1.Patients having serious medical conditions requiring priority treatment. 2.Patients having history of using smokeless tobacco since the last 1 year. 3.Women who are pregnant, or intending to become pregnant or lactating mothers. •Patient having comorbid psychiatric disorder. •Patients who are unwilling to take NRT or are already on NRT.

Design outcomes

Primary

MeasureTime frame
1. Tobacco Cessation Status - Measured by Importance Readiness and Confidence (IRC) scale at 2 weeks and 6 weeks - Self-reported outcomes: - Reduced use - Quit attempt (24-hour point period abstinence) - Point period abstinence (7-day point period abstinence) - Complete abstinence (28-day/4-week point period abstinence) - Lapse (slip between abstinence) - Relapse Timepoint: at Baseline, 2th week, 4th week & 12th week

Secondary

MeasureTime frame
Urine Cotinine levelTimepoint: After 12 weeks

Countries

India

Contacts

Public ContactDr Aman Rajput

Faculty of Dental Sciences, King Georges Medical University, Lucknow, UP

vinaykumargupta@kgmcindia.edu9794153902

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026