Smoking Relapse Prevention Among COPD Ex-smokers

NCT ID: NCT02888444

Last Updated: 2019-05-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-31
• Study Completion Date: 2018-04-13

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.

Conditions

Chronic Obstructive Pulmonary Disease; Smoking Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Varenicline plus behavioural support

12 weeks extended treatment with varenicline, plus relapse prevention-orientated behavioural support

Group Type: ACTIVE_COMPARATOR

Varenicline

Intervention Type: DRUG

Two 0.5mg tablets taken twice daily

Behavioural support

Intervention Type: BEHAVIORAL

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.

Placebo plus behavioural support

12 weeks extended treatment with placebo, plus relapse prevention-orientated behavioural support

Group Type: PLACEBO_COMPARATOR

Behavioural support

Intervention Type: BEHAVIORAL

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.

Placebo

Intervention Type: DRUG

Two 0.5mg tablets taken twice daily

Interventions

Varenicline

Two 0.5mg tablets taken twice daily

Intervention Type: DRUG

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.

Intervention Type: BEHAVIORAL

Placebo

Two 0.5mg tablets taken twice daily

Intervention Type: DRUG

Other Intervention Names

Champix

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Auckland, New Zealand

OTHER

Sponsor Role: lead

Responsible Party

Natalie Walker

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Natalie Walker, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Auckland, New Zealand

Locations

National Institute for Health Innovation, University of Auckland

Auckland, , New Zealand

Countries

New Zealand

Other Identifiers

113

Identifier Type: -

Identifier Source: org_study_id