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Effect of a new anti-tobacco drug on stopping tobacco use

EFFECTIVENESS OF VARENICLINE TARTRATE ON CESSATION OF VARIOUS FORMS OF TOBACCO - A RANDOMIZED CONTROL TRIAL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/10/016226
Enrollment
70
Registered
2018-10-31
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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: Varenicline tartrate along with Tobacco cessation counselling: Varenicline tartrate 1-3 days-0.5 mg once daily 4-7 days-0.5 mg twice daily 8-77 days-1 mg twice daily Intervention2: Vare

Sponsors

R Gokila
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All current tobacco users aged 18 to 75 years who are reporting with difficulty in quitting 1 week after health education (I session of Tobacco cessation counselling) with medium/high dependency for tobacco.

Exclusion criteria

Exclusion criteria: Patients with history of seizures Patients with systemic diseases (allergic, hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric or neurological disease, or any condition possibly affecting drug absorption) Patients with psychological disorders or other mental health problems Juvenile population less than 18 years Those who have reported hypersensitivity reaction to the drug. Pregnant and lactating ladies Patients who are already under medication for tobacco cessation

Design outcomes

Primary

MeasureTime frame
Self-reported abstinence by patientsTimepoint: Self-reported abstinence by patients during 1st, 2nd and 3rd month end of the trial

Secondary

MeasureTime frame
Fagerstrom level of dependency scale, Lobene stain indexTimepoint: Baseline values are taken at the first visit and the patients are followed up on 4th, 8th and 12th weeks

Countries

India

Contacts

Public ContactR Gokila

Tamil Nadu Government Dental College and Hospital

mban1965@yahoo.com9840127997

Outcome results

None listed

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