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

NCT02894957 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2019-09-24

No results posted yet for this study

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.

Conditions

  • Smoking Cessation

Interventions

DRUG

Varenicline

: 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.

Sponsors & Collaborators

  • Shaare Zedek Medical Center

    lead OTHER

Principal Investigators

  • Abraham BOHADANA, MD · Shaare Zedek Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-31
Primary Completion
2019-12-31
Completion
2019-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02894957 on ClinicalTrials.gov