Varenicline and nicotine replacement therapy for smokers admitted to hospitals

Phase 4

Completed

• Conditions: Nicotine Dependence; icotine Dependence; Mental Health - Addiction

• Registration Number: ACTRN12618001792213
• Lead Sponsor: Monash University, Faculty of Pharmacy and Pharmaceutical Sciences, Centre for Medicine Use and Safety

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-02
• Study Completion: 2022-07-08
• Last Update Posted: 10 April 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

Adults aged 18 years or over, admitted to participating hospitals with a history of smoking 10 or more cigarettes per day on average in the four weeks prior to their hospital admission, interested in quitting smoking, willing to use pharmacotherapy and available for 12 months follow-up post-discharge and willing/capable to provide signed informed consent will be eligible for the study. This study will not recruit any outpatient smokers.

Exclusion Criteria

Patients who do not meet all of the above inclusion criteria, those who have a terminal illness with an anticipated survival of of less than 6 months, those who have an unstable cardiovascular status or a current major psychiatric illness as well as those admitted to outpatient clinics will be excluded from the study. Patients unable to communicate in English and provide written consent will also be excluded due to the potential need to regularly communicate with the investigators during the entire trial period and the lack of funding available for interpreters. Further exclusion criteria for this study are women who are pregnant, breastfeeding or planning to become pregnant in the next 6 months, patients who are current (on the day of hospital admission) users of smoking cessation medications or approaches (i.e. NRT, varenicline, bupropion [Zyban™], clonidine, nortriptyline, electronic nicotine cigarettes), those currently participating in other smoking cessation programs or study, patients who have completed a 12 weeks or longer course of varenicline in the 12 months prior to their hospitalisation, those who have had intolerable adverse reactions from the use of varenicline or NRTs in the past as well as people who have contraindications for their use (including those using medications known to have major interactions with either varenicline or NRT).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
This is defined as a self-report of smoking not more than five cigarettes from the start of the abstinence period, supported by a negative biochemical test at the final follow-up. <br>A standard abstinence question is: ‘Have you smoked at all since (date of start of abstinence period) A: No, not a puff; B: 1–5 cigarettes; C: More than 5 cigarettes?’. Answer A or B and a negative CO breath test are required for the participant to be classified as abstinent. A participant with CO level less than 10 ppm will be considered abstinent. CO levels will be measured by a trained RA, blinded to treatment allocation, using a hand held piCO+ Smokerlyzer (Bedfont Scientific, Maidstone, Kent, UK) during a hospital or home visit.[6 months from hospital discharge]