NCT02888444

Smoking Relapse Prevention Among COPD Ex-smokers

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: University of Auckland, New Zealand · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Chronic Obstructive Pulmonary Disease
• Smoking Cessation

Interventions

Type	Name	Description
DRUG	Varenicline	Two 0.5mg tablets taken twice daily
BEHAVIORAL	Behavioural support	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.
DRUG	Placebo	Two 0.5mg tablets taken twice daily

Timeline

• Start date: 2017-07-31
• Primary completion: 2018-04-13
• Completion: 2018-04-13
• First posted: 2016-09-05
• Last updated: 2019-05-15

Locations

1 site across 1 country: New Zealand