The IMP will assist smoking cessation in smokers wishing to stop.
Conditions
Interventions
Trade Name: NiQuitin CQ 21 mg Patch
Product Name: NiQuitin clear 21mg (Niquitin clear 14mg where indicated)
Pharmaceutical Form: Transdermal patch
INN o
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Smokers aged = 18 years of age (assessed on telephone screening) • Smokers who, in the judgement of the clinician, would be suitable for preloading (assessed on telephone screening and in clinic). • Those seeking NHS support to stop smoking (assessed on telephone screening) and willing to quit in 4 weeks • Those able and willing to comply with study procedures (assessed on telephone screening). Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1429 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 357
Exclusion criteria
Exclusion criteria: • Those who are pregnant or breastfeeding (assessed on telephone screening) • Those with extensive dermatitis/other skin disorder that precludes patch use (assessed on telephone and clinic screening) • Those with acute coronary syndrome or stroke within the past three weeks (assessed on telephone screening) • Those with active phaeocromocytoma and uncontrolled hyperthyroidism (assessed on telephone screening)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess six month prolonged abstinence from smoking in all participants, measured by the Russell standard criteria ('abstinence' is defined as smoking fewer than 5 cigarettes following a quit date and biochemically confirmed by an exhaled CO of <10 parts per million).;Secondary Objective: To assess the no. of participants smoking at four weeks and 12 months after quit day using self report only, not biologically confirmed. To assess no. of participants at 4 weeks, 6 and 12 months who have not been smoking for the previous 7 days. To collect data on the side-effects of NRT patch use and symptoms of nicotine overdose (such as nausea, excessive salivation) at each contact.;Primary end point(s): 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 and biochemically confirmed by an exhaled Carbon monoxide (CO) reading of less than 10 parts per million.;Timepoint(s) of evaluation of this end point: 6 months after quit day. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Four week and 12 month abstinence and 7-day point prevalence biochemically confirmed abstinence at 4 weeks, 6 and 12 months according to the Russell Standard (validated CO must be less than 10 parts per million).;Timepoint(s) of evaluation of this end point: 4 weeks, 6 and 12 months after quit day. | — |
Countries
United Kingdom
Contacts
Public ContactNicola Lindson
University of Birmingham
Outcome results
None listed