Smoking Relapse Prevention Among COPD Ex-smokers (SPACE)

University of Auckland, New Zealand

Status and phase: Terminated; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease; Smoking Cessation

Treatments: Drug: Varenicline; Drug: Placebo; Behavioral: Behavioural support

Study type: Interventional

Funder types: Other

Identifiers

NCT02888444

113

Details and patient eligibility

About

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

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

8 participants in 2 patient groups, including a placebo group

Varenicline plus behavioural support

Active Comparator group

Description:

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

Treatment:

Behavioral: Behavioural support

Drug: Varenicline

Placebo plus behavioural support

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Behavioral: Behavioural support