Varenicline for "Gradual" vs. "Abrupt" Smoking Cessation in Low-motivated COPD Smokers

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.

Timeline

Start

2019-10

Primary completion

2019-12

Completion

2019-12

Publications

• Bohadana A, Rokach A, Wild P, Peker B, Dror YF, Babai P, Arish N, Izbicki G. Varenicline for Gradual Versus Abrupt Smoking Cessation in Poorly Motivated Smokers With COPD: A Prematurely Terminated Randomized Controlled Trial. Chronic Obstr Pulm Dis. 2022 Oct 26;9(4):486-499. doi: 10.15326/jcopdf.2022.0305.

Drugs

Indications

No indication recorded.