Tobacco smoking
Conditions
Interventions
Active treatment arm: daily 24hr use of 21mg nicotine transdermal patches over a four week period prior to participants quitting smoking.
Control arm: no pharmacotherapy. Minimal behav
Sponsors
University of Birmingham (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Smokers (defined as regular smokers of cigarettes, cigars, and tobacco cigarettes combined with marijuana) 2. Aged =18 years of age 3. Smokers who, in the judgement of the trial researcher, would be suitable for preloading 4. Seeking NHS support to stop smoking and willing to quit in 4 weeks 5. Able to understand and consent to, and willing to comply with, study procedures
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding 2. Extensive dermatitis/other skin disorder that precludes patch use 3. Acute coronary syndrome or stroke within the past three weeks 4. Active phaeocromocytoma 5. Uncontrolled hyperthyroidism
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current secondary outcome measure (as of 24/01/2018): Six month prolonged abstinence, measured by the Russell standard criteria i.e. a grace period of 2 weeks, followed by smoking fewer than 5 cigarettes thereafter to six months and biochemically confirmed by an exhaled CO of <10ppm or a salivary cotinine <14ng/ml. This is assessed in the same way as all smoking-related outcomes, namely by participant self-report confirmed biochemically. Previous primary outcome measure Six month prolonged abstinence, measured according to the Russell standard criteria, i.e. a grace period of 2 weeks, followed by smoking fewer than 5 cigarettes thereafter and biochemically confirmed by an exhaled CO of <10ppm | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures (as of 24/01/2018): 1. Russell standard abstinence at 4 weeks and 12 months, measured and defined analogously. They also comprise seven-day point prevalence, meaning total abstinence by self-report for the seven preceding days confirmed biochemically, as in the Russell standard measures. 2. Adverse events (adverse health states reported by the participant that occurred for the first time between baseline and the second assessment ) are self-reported in response to enquiry by the trial staff at one week after baseline and one week after quit day (approximately 5 weeks after baseline). We will also assess some adverse events that may indicate an excess dose of nicotine by a self-completion questionnaire one week after baseline. 3. Costs of behavioural support and NRT, in order to calculate cost/lifetime quitter, the cost/life year gained and the cost/quality adjusted life year, and health service use. 4. Potential mediators of the preloading effect will be measured at baseline, one week later in the pre-quit period, and one week after quit day by self-completion questionnaire: 4.1 Positive reinforcement: modified Cigarette Evaluation Questionnaire (mCEQ) satisfaction subscale and noticing whether cigarettes were more or less enjoyable than previously. 4.2 Negative reinforcement: mCEQ reward subscale. 4.3 Drive to smoke: self-reported change in urge strength and frequency of urges to smoke combined assessed using the Mood and Physical Symptoms Scale Craving subscale (MPSS-C), smoking stereotypy taken from the Nicotine Dependence Syndrome Scale, the mCEQ craving question, and a question used by Hajek and colleagues in a similar trial that asked participants to rate their urge to smoke compared with usual. 4.4 Cigarette consumption: cigarettes per day, and exhaled carbon monoxide. 4.5 Symptoms | — |
Countries
United Kingdom
Outcome results
None listed