Clinical trial NCT02888444: Smoking Relapse Prevention Among COPD Ex-smokers
Official title: Smoking Relapse Prevention Among COPD Ex-smokers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Smoking Cessation
Lead sponsor: University of Auckland, New Zealand
Sponsor class: OTHER
First posted: 2016-09-05
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Continuous abstinence
timeFrame: 12 weeks post-randomisation
Secondary outcomes:
measure: Continuous abstinence
timeFrame: 24 weeks post-randomisation
measure: 7-day point prevalence abstinence
timeFrame: 12 weeks post-randomisation
measure: 7-day point prevalence abstinence
timeFrame: 24 weeks post-randomisation
measure: Time to lapse
timeFrame: 12 weeks post-randomisation
measure: Time to lapse
timeFrame: 24 weeks post-randomisation
measure: Time to relapse
timeFrame: 12 weeks post-randomisation
measure: Time to relapse
timeFrame: 24 weeks post-randomisation
measure: Cigarettes per day
timeFrame: 12 weeks post-randomisation
measure: Cigarettes per day
timeFrame: 24 weeks post-randomisation
measure: COPD exacerbations requiring hospitalisation
timeFrame: 12 weeks post-randomisation
measure: COPD exacerbations requiring hospitalisation
timeFrame: 24 weeks post-randomisation
measure: Urge to smoke/cravings
timeFrame: 12 weeks post-randomisation
measure: Urge to smoke/cravings
timeFrame: 24 weeks post-randomisation
measure: Cigarette dependence
timeFrame: 12 weeks post-randomisation
measure: Cigarette dependence
timeFrame: 24 weeks post-randomisation
measure: Health-related quality of life
timeFrame: 12 weeks post-randomisation
measure: Health-related quality of life
timeFrame: 24 weeks post-randomisation
measure: Serious adverse events
timeFrame: 12 weeks post-randomisation
measure: Serious adverse events
timeFrame: 24 weeks post-randomisation
Other outcomes:
measure: Medication adherence (Script redeemed)
timeFrame: 12 weeks post-randomisation
measure: Question about medication compliance (pill count).
timeFrame: 12 weeks post-randomisation
measure: Question about use of other cessation products
timeFrame: 12 weeks post-randomisation
measure: Questions asked about the use of other cessation products
timeFrame: 24 weeks post-randomisation
Locations:
city: Auckland
country: New Zealand
facility: National Institute for Health Innovation, University of Auckland
Study officials:
affiliation: University of Auckland, New Zealand
name: Natalie Walker, PhD
role: PRINCIPAL_INVESTIGATOR
References: