Effects of an extended period of varenicline use prior to quitting smoking on post-quitting urges to smoke - Use of varenicline for 4-weeks prior to quitting

Conditions: Tobacco Dependence (Smoking Cessation)
MedDRA version: 9.1Level: LLTClassification code 10008374Term: Cessation of smoking
MedDRA version: 9.1Level: LLTClassification code 10053325Term: Smoking cessation therapy

Registration Number: EUCTR2008-004720-24-GB

Lead Sponsor: Queen Mary and Westfield College, University of London

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

Smokers seeking treatment, aged 18 and over, consenting to take part in the trial.
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

Pregnant or breastfeeding, end-stage renal disease, used varenicline in the past 6 months, unable to fill in questionnaires in English, current psychiatric illness, current serious illness, currently enrolled in other research projects.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The principal question this pilot project plans to answer is does using varenicline for 4-weeks prior to quitting reduce post-quitting urges to smoke and withdrawal severity more than the usual usage of 1-week prior to quitting. ;Secondary Objective: In addition to change in urges to smoke and other withdrawal symptoms this study will determine if extended use of varenicline prior to quitting (4-weeks versus 1-week) affects:<br>(a) carbon monoxide levels (measured in expired breath)<br>(b) cotinine (a by-product of nicotine) levels in saliva<br>(c) cigarette satisfaction<br>(d) short-term quit rates (measured at 1, 4 and 12 weeks after the quit date);Primary end point(s): Rating of urges to smoke 24 hours and one week after the target quit date assessed by Mood and Physical Symptoms Scale.

Secondary Outcome Measures