Varenicline for "Gradual" vs. "Abrupt" Smoking Cessation in Low-motivated COPD Smokers
Status:
Unknown status
Trial end date:
2019-12-01
Target enrollment:
Participant gender:
Summary
Rationale: No studies have examined the effect of varenicline for "gradual" smoking cessation
in COPD smokers currently not interested in quitting.
Objective: To compare the efficiency of varenicline-assisted "gradual" vs. "abrupt" smoking
cessation in low-motivated COPD smokers
Setting: Pulmonary outpatient clinic
Design: Open, randomized pilot smoking cessation trial
Participants: COPD smokers with low motivation to quit. Such low motivation will be defined
as a score of ≤ 3 points observed in a 10 cm visual analog scale (0=non motivated; 10=highly
motivated).
Interventions/procedures: Patients will be randomized either to receive varenicline
(uptitrated to 1 mg twice daily) for smoking reduction or smoke as usual for 4-6 weeks before
quitting. After quit-day, the two groups will receive standard 12-week varenicline treatment.
Non-treatment follow-up will continue to 6 months.
Measurements: The main outcome measure is carbon monoxide-verified complete abstinence rate
(CAR) 6 months after quit-day. Other measures are: CAR at 3 months; point prevalence at 3 and
6 months; change in motivation; cigarettes/day; differential dropout rate; decline in
pulmonary function; COPD symptoms, episodes of exacerbation and medication; and adverse
events.
Sample size: One hundred twenty-one subjects per group will be necessary to detect CAR
differences between the two groups of 15% at 6 months.
Potential study limitations: The main potential limitation is the lack of 1-yr follow-up.
Relevance: This study may provide useful preliminary information on the safety and efficiency
of varenicline for "gradual" smoking cessation in low-motivated COPD smokers and it may
assist in the preparation of a larger, more comprehensive trial.