Open label randomised trial of nicotine replacement therapy and oral smokeless tobacco (snus) in smoking cessation - STONES

Phase 1

Conditions: Smoking cessation
MedDRA version: 14.1Level: PTClassification code 10053325Term: Smoking cessation therapySystem Organ Class: 10042613 - Surgical and medical procedures

Registration Number: EUCTR2006-004461-34-GB

Lead Sponsor: niversity of Nottingham

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine whether snus is more effective than NRT as a smoking cessation therapy<br>;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 <br>;Primary end point(s): CO-validated (<8 ppm) smoking abstinence at 26 weeks.

Secondary Outcome Measures