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Use of Nicotine to stop tobacco addiction in tuberculosis patients

Effectiveness of Nicotine Replacement inclusive Therapy on Tobacco Cessation of Tuberculosis Patients: An Open Label Before-After Non-Control Quasi Experimental Clinical Trial

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/06/043045
Enrollment
120
Registered
2022-06-06
Start date
Unknown
Completion date
Unknown
Last updated
2023-02-06

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

Conditions

Health Condition 1: A150- Tuberculosis of lung

Interventions

Intervention1: Nicotine Replacement Therapy: Light user- NRT patch 14mg/day (0-6weeks) 7mg/day (7-9weeks and 10-12 weeks ) Moderate Users- NRT patch 21 mg/day (0-6 weeks), 14 mg/day (7-9 weeks), 07 mg

Sponsors

PRAVARA INSTITUTE OF MEDICAL SCIENCES
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Active tuberculosis (Pulmonary or Extra pulmonary) patient who are on Directly Observed Treatment & Short Course Chemotherapy and not have completed more than one month of therapy 2. Patient of either gender >= 18 years of age 3. Habituated/Addicted to Tobacco (Smoking/Smokeless) 4. Ready to give informed consent

Exclusion criteria

Exclusion criteria: Sever debilitating patients 2. HIV associate Tuberculosis 3. MDR/XDR patients 4. Not willing to 06 (01 per week) follows up 5. Participants who quit smoking within 04 weeks of trial 6. Patients contraindicated for NRT (recent history of myocardial infarction, angina; pregnancy & lactation

Design outcomes

Primary

MeasureTime frame
smoking abstinence or non-abstinenceTimepoint: weekly follow up for 6 weeks

Secondary

MeasureTime frame
number of quit attempts, number of times tobacco consumed, number of smoked cigarettes/bidis per day, smoking excess or smoking reduction, continued use and relapse from the baseline information.Timepoint: weekly follow up for 6 weeks

Countries

India

Contacts

Public ContactDr Prashant Viragi

Rural Dental College, PIMS-DU

prashantimpact@yahoo.com

Outcome results

None listed

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