A non-inferiority trial of cytisine versus varenicline for smoking cessatio

Phase 3

Active, not recruiting

• Conditions: Tobacco use and dependence; Public Health - Other public health; Mental Health - Addiction

• Registration Number: ACTRN12616001654448
• Lead Sponsor: niversity of New South Wales

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-30
• Last Update Posted: 17 February 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 1452

Inclusion Criteria

Participants will be at least 18 years of age; current daily smoker; motivated and willing to make a quit attempt using medications (cytisine/varenicline); able to provide informed consent; have access to a telephone; and willing to complete baseline and follow-up telephone interviews.

Exclusion Criteria

Women who are pregnant, breastfeeding or planning to become pregnant in the next six months will be excluded from this trial, as will current users of smoking cessation medications or those who are participating in another smoking cessation program or study. The current users of varenicline and cytisine, and those with known hypersensitivity to the active substance or to any of the excipients also will be excluded. People will also be excluded if they report any of the following medical conditions in the previous three months: arrhythmia, heart attack, stroke, or severe angina.People with pheochromocytoma and hyperthyroidism also will be excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified