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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-004720-24-GB

Enrollment

100

Registered

2009-04-14

Start date

2009-03-27

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Trade Name: Champix Pharmaceutical Form: Film-coated tablet Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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: (a) carbon monoxide levels (measured in expired breath) (b) cotinine (a by-product of nicotine) levels in saliva (c) cigarette satisfaction (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.	—

Measure

Time frame

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: (a) carbon monoxide levels (measured in expired breath) (b) cotinine (a by-product of nicotine) levels in saliva (c) cigarette satisfaction (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.

—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026