Smoking cessation and reduction Mental and Behavioural Disorders
Conditions
Interventions
Smokers with a smoking-related chronic disease and who have no intention of stopping immediately or seeking cessation support are randomised to one of two groups if they decline referral to NHS stop s
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participant is willing and able to give informed consent for participation in the study 2. Aged 18 years or above 3. Current smoker with a value of at least 10 parts per million (ppm) for exhaled carbon monoxide (CO) 4. Diagnosed with one or more of the following chronic conditions: ischaemic heart disease, peripheral vascular disease, hypertension, diabetes mellitus (Type 1 and Type 2), stroke, asthma, COPD, chronic kidney disease, depression, schizophrenia, bipolar disorder or other psychoses
Exclusion criteria
Exclusion criteria: 1. GP believes that switching to e-cigarettes would not benefit the patient given their current medical condition 2. Currently using e-cigarettes, nicotine replacement therapy or non-nicotine based cessation therapies (e.g. bupropion, nortriptyline or varenicline) 3. Plans to stop smoking before or at the annual review 4. Currently enrolled in another smoking-related study or other study where the aims of the studies are incompatible 5. Cannot consent due to mental incapacity 6. Pregnant, breastfeeding or planning to become pregnant during the course of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The first primary outcome is 7-day point-prevalence abstinence from smoked tobacco at two months. Abstinence is defined as complete self-reported abstinence from smoking – not even a puff – in the past seven days, accompanied by a salivary anabasine concentration of <1ng/ml. 2. The second primary outcome is reduction in cigarette consumption at two months. Reduction is defined as a 50% reduction in self-reported cigarettes per day on each of the last seven days at two months compared with baseline consumption, accompanied by evidence of reduced smoke intake indicated by salivary anabasine concentrations lower than baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures for abstinence include 7-day point prevalence abstinence measured at eight months, biochemically confirmed by an exhaled CO of <10 ppm. Six-month prolonged abstinence will be measured using the Russell standard criteria, defined as smoking fewer than five cigarettes between two and eight month follow-ups, confirmed by an anabasine concentration of <1ng/ml at two months and an exhaled CO concentration of <10ppm at eight months. | — |
Countries
England, United Kingdom
Outcome results
None listed