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

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shaare Zedek Medical Center
• Treatments: Varenicline

Criteria

Inclusion Criteria:

• Men or women aged ≥35 years

• Currently smoking 10 cigarettes per day or more

• Having smoked 15 py or more

• Presenting a CO level in expired air ≥ 10 ppm

• With low motivation to quit as defined below.

• Willing to sign a statement of informed consent

• Willing to sign a written commitment to quit at a target quit date

• Women of child bearing potential should agree to use acceptable contraception methods.

Exclusion Criteria:

• History of treatment with systemic corticosteroids or hospitalization for a COPD exacerbation in the 4-wk period prior to enrolment.

• Diagnosis of depression or current treatment with antidepressants.

• History of serious psychiatric disorder.

• Myocardial infarction within the last 3 months

• Unstable angina

• Severe cardiac arrhythmia

• Use of any form of smokeless tobacco or nicotine substitution or having followed any cessation program in the past 3 months

• Alcohol or other drug addiction

• Pregnant or lactating women