Smoking cessation MedDRA version: 14.1 Level: PT Classification code 10053325 Term: Smoking cessation therapy System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Product Name: swedish snus
Pharmaceutical Form: Prolonged-release capsule, soft
INN or Proposed INN: nicotine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 7-
INN
Sponsors
University of Nottingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All smokers aged 18 and over presenting to the 'New Leaf' smoking cessation service in Nottingham will be eligible to participate if they: •report that they currently smoke 10 or more cigarettes per day •are willing to consider participation •have an exhaled carbon monoxide (CO) level of 10 ppm or more Smokers with a past history of a failed quit attempt involving NRT, bupropion or nortryptiline will be eligible but with a minimum period of four weeks without any smoking cessation therapy before entry into the present study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: All smokers aged 18 and over presenting to the 'New Leaf' smoking cessation service in Nottingham will not be eligible to participate if they: •are pregnant, likely to become pregnant, or breastfeeding •have serious co-morbidity (including myocardial infarction or stroke within the past three months, current unstable angina, alcohol or drug abuse or psychiatric illness) •have currently active eczema or psoriasis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether snus is more effective than NRT as a smoking cessation therapy ;Secondary Objective: To assess the likely acceptability and uptake of snus as a smoking cessation agent, assess adverse effects, and determine relative efficacy in more dependent and/or disadvantaged smokers ;Primary end point(s): CO-validated (<8 ppm) smoking abstinence at 26 weeks. | — |
Countries
United Kingdom
Outcome results
None listed