A non-inferiority trial of cytisine versus varenicline for smoking cessation
A randomised controlled non-inferiority clinical trial to evaluate the cost-effectiveness and safety of cytisine compared to varenicline as a treatment for people who wish to stop smoking
University of New South Wales
1,450 participants
Nov 16, 2017
Interventional
Conditions
Summary
This study will evaluate the cost-effectiveness of cytisine in comparison with varenicline. A total of 1450 smokers will be recruited from state Quitline services. Participants will have an equal chance of being randomly allocated to either the intervention or control arm (1:1 ratio). Participants in the intervention arm will receive a 25-day supply of cytisine capsules (1.5 mg cytisine). Participants in the varenicline arm will receive a 12-week supply of varenicline tablet (0.5 mg/1.0 mg varenicline). All participants will also receive standard Quitline behavioural support. All participants will be followed-up for six months and the follow-up interviews will be held at one, three and six months after the quit date. The main outcome measures are abstinence from smoking at one, three and six months follow-ups.
Eligibility
Inclusion Criteria1
- 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 Criteria1
- 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.
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Interventions
All participants in the intervention arm will receive a 25-day supply of 1.5 mg cytisine capsules. The recommended dosing schedule includes: 1 to 3 days – 1 capsule every 2 hours (max 6 capsules/day); 4 to 12 days – 1 capsule every 2.5 hours (max 5 capsules/day); 13 to 16 days – 1 capsule every 3 hours (max 4 capsules/day); 17 to 20 days – 1 capsule every 5 hours (max 3 capsules/day); 21 to 25 days- 1 capsule every 6 hours (max 2 capsules/day. All participants in the intervention arm will be advised to reduce their smoking over the first four days of treatment and quit completely on the fifth day which will be their designated quit date. Participants' self-reported adherence to the treatment will be assessed during follow-up interviews.
Locations(1)
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ACTRN12616001654448