Smoking Relapse Prevention Among COPD Ex-smokers
- Conditions
- Chronic Obstructive Pulmonary DiseaseSmoking Cessation
- Interventions
- Registration Number
- NCT02888444
- Lead Sponsor
- University of Auckland, New Zealand
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 8
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo plus behavioural support Behavioural support 12 weeks extended treatment with placebo, plus relapse prevention-orientated behavioural support Placebo plus behavioural support Placebo 12 weeks extended treatment with placebo, plus relapse prevention-orientated behavioural support Varenicline plus behavioural support Behavioural support 12 weeks extended treatment with varenicline, plus relapse prevention-orientated behavioural support Varenicline plus behavioural support Varenicline 12 weeks extended treatment with varenicline, plus relapse prevention-orientated behavioural support
- Primary Outcome Measures
Name Time Method Continuous abstinence 12 weeks post-randomisation Continuous (lapse-free) abstinence biochemically validated using a carbon monoxide reading of \<10 ppm.
- Secondary Outcome Measures
Name Time Method 7-day point prevalence abstinence 24 weeks post-randomisation Biochemically validated 7-day point prevalence abstinence, defined as no smoking in the last seven days, not even a puff.
COPD exacerbations requiring hospitalisation 24 weeks post-randomisation The number of COPD exacerbations in the past 12 weeks, defined as a worsening of COPD respiratory symptoms that resulted in a course of antibiotics and/or oral steroids; or an unscheduled visit to GP, urgent care, Emergency Department or as an inpatient. Data will be validated against medical records using data linkage.
Continuous abstinence 24 weeks post-randomisation Biochemically validated continuous (lapse-free) abstinence
Time to lapse 24 weeks post-randomisation Time to first lapse, defined as time to first cigarette smoked (even a puff)
Time to relapse 24 weeks post-randomisation Time to first relapse, defined as smoking ≥five cigarettes a day for three consecutive days.
Cigarette dependence 24 weeks post-randomisation Cigarette dependence, as measured by the Fagerström Test of Cigarette Dependence
Health-related quality of life 24 weeks post-randomisation Measured using the EQ-5D
Cigarettes per day 24 weeks post-randomisation Cigarettes smoked per day, if returned to smoking
Urge to smoke/cravings 24 weeks post-randomisation The physical signs and symptoms associated with withdrawal will be measured using the Mood and Physical Symptoms Scale (MPSS).
Serious adverse events 24 weeks post-randomisation
Trial Locations
- Locations (1)
National Institute for Health Innovation, University of Auckland
🇳🇿Auckland, New Zealand