Farmacologic prevention with Varenicline in heavy smokers undergoing early detection lung cancer screening - ND

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-014301-14-IT

Enrollment

600

Registered

2009-08-07

Start date

2009-07-15

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

Heavy smokers with higher risk in developing lung cancer and smoke related diseases MedDRA version: 9.1 Level: SOC Classification code 10038738 MedDRA version: 9.1 Level: HLGT Classification code 10038716 MedDRA version: 9.1 Level: HLGT Classification code 10029107 MedDRA version: 9.1 Level: HLT Classification code 10006334

Interventions

Trade Name: CHAMPIX*11x0,5MG+14x1MG+28x1MG Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Varenicline Concentration type: equal

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy Smokers Age range 50-75 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Kidney, cardiovascular and neurological diseases. Depression, psychosis, eating disorder Alcohol abuse and antidepressant therapy

Design outcomes

Primary

Measure	Time frame
Main Objective: Improve smoking cessation by farmacological prevention in a lung cancer screening program. Evaluate adhesion to protocol and percentage of quit smokers at 3, 6 and 12 months. Evaluate if involvement of general practitioner may improve adhesion to protocol and long term quit rate;Secondary Objective: Evaluate the psicological factors that motivate subjects to enter in a pharmacological prevention program as alternative or complementary to a CT evaluation;Primary end point(s): Reduction in smokers number by pharmacological treatment	—

Measure

Time frame

Main Objective: Improve smoking cessation by farmacological prevention in a lung cancer screening program. Evaluate adhesion to protocol and percentage of quit smokers at 3, 6 and 12 months. Evaluate if involvement of general practitioner may improve adhesion to protocol and long term quit rate;Secondary Objective: Evaluate the psicological factors that motivate subjects to enter in a pharmacological prevention program as alternative or complementary to a CT evaluation;Primary end point(s): Reduction in smokers number by pharmacological treatment

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Countries

Italy

Outcome results

None listed

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