Smoking Relapse Prevention Among COPD Ex-smokers

Phase 3TerminatedNCT02888444

University of Auckland, New Zealand8 enrolled

Overview

A placebo-controlled trial to determine whether recent ex-smokers with COPD who successfully stop smoking after taking varenicline are less likely to relapse back to smoking if they continue using varenicline for a further 12 weeks

Smoking remains the leading cause of Chronic Obstructive Pulmonary Disease (COPD), a leading cause of death and disability in New Zealand. COPD particularly affects indigenous Māori and Pacific people, given their higher rates of smoking. COPD patients tend to have a higher level of nicotine dependence and, as a result, often find quitting harder and are more likely to relapse back to smoking. A clinical trial (N=262) is planned in Auckland, New Zealand to determine whether extended varenicline treatment combined with behavioural support can prevent relapse back to smoking in recent ex-smokers with COPD. Smoking cessation and relapse prevention are the most cost-effective interventions available for COPD patients that smoke, irrespective of their disease stage. The trial has the potential to significantly improve the outcomes of this common and chronic health condition in New Zealand.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Chronic Obstructive Pulmonary Disease Smoking Cessation

Interventions

VareniclineDRUG

Two 0.5mg tablets taken twice daily

Behavioural supportBEHAVIORAL

Consisting of the study-specific doctor delivering relapse prevention orientated behavioural support at the time of consultation, plus six 10-15 minute calls over the 12 weeks delivered by a research assistant.

PlaceboDRUG

Two 0.5mg tablets taken twice daily

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Daily smokers * Diagnosed with COPD (as per the Global Initiative for Chronic Obstructive Lung Disease \[GOLD\] criteria, namely: a characteristic clinical picture of dyspnea, cough or sputum, with a history of exposure to risk factors, plus a post-bronchodilator forced expiratory volume in one second / forced vital capacity FEV1/FVC ratio of \<0.70) * Have stable COPD (i.e. no exacerbation, hospital admission, or use of antibiotics or prednisone in the past six weeks) * Can provide consent * Reside in the Auckland region of New Zealand * Eligible under New Zealand special authority to receive subsidised varenicline * Prepared to make a quit attempt with varenicline * Have access to a phone Exclusion Criteria: * A history of definite asthma and/or atopy * Contraindications to varenicline * Used varenicline in the past 12 months * A history of serious psychiatric illness or significant cognitive impairment * Major or uncontrolled co-morbidities (such as uncontrolled heart failure, infection or rapidly progressive condition) * A life expectancy of \< 12 months * Are currently using another cessation medication (including e-cigarettes)

Locations (1)

National Institute for Health Innovation, University of Auckland

Auckland, New Zealand

Outcomes

Primary Outcomes

Continuous abstinence

Continuous (lapse-free) abstinence biochemically validated using a carbon monoxide reading of \<10 ppm.

Time frame: 12 weeks post-randomisation

Secondary Outcomes

Continuous abstinence

Biochemically validated continuous (lapse-free) abstinence

Time frame: 24 weeks post-randomisation

7-day point prevalence abstinence

Biochemically validated 7-day point prevalence abstinence, defined as no smoking in the last seven days, not even a puff.

Time frame: 12 weeks post-randomisation

7-day point prevalence abstinence

Biochemically validated 7-day point prevalence abstinence, defined as no smoking in the last seven days, not even a puff.

Time frame: 24 weeks post-randomisation

Time to lapse

Time to first lapse, defined as time to first cigarette smoked (even a puff)

Time frame: 12 weeks post-randomisation

Time to lapse

Time to first lapse, defined as time to first cigarette smoked (even a puff)

Time frame: 24 weeks post-randomisation

Time to relapse

Time to first relapse, defined as smoking ≥five cigarettes a day for three consecutive days.

Time frame: 12 weeks post-randomisation

Time to relapse

Time to first relapse, defined as smoking ≥five cigarettes a day for three consecutive days.

Data from ClinicalTrials.gov

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