Use of Varenicline for 4-Weeks Prior to Quitting - Full Text View

Sponsored by:	Queen Mary University of London
Information provided by:	Queen Mary University of London
ClinicalTrials.gov Identifier:	NCT00789074

Purpose

Varenicline (Champix) is a relatively new medicine that is effective in helping people to quit smoking. It is normally started 1-week before stopping smoking and used for up to 12-24 weeks. We are trying to find out if using varenicline for an extended time (4-weeks) before stopping smoking is better than the standard 1-week of use prior to stopping.

The study will recruit 100 smokers who want to stop. They will be randomly allocated to receive varenicline(4−weeks) or placebo (3−weeks followed by 1−week of active treatment as indicated by standard prescribing practice), followed by a 12−week open label treatment period where all participants will receive varenicline.

Condition	Intervention	Phase
Tobacco Dependence Smoking Cessation	Drug: Varenicline Drug: Placebo	Phase III

MedlinePlus related topics: Quitting Smoking Smoking

Drug Information available for: Varenicline

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Effects of an Extended Period of Varenicline Use Prior to Quitting Smoking on Post-Quitting Urges to Smoke

Further study details as provided by Queen Mary University of London:

Primary Outcome Measures:

Rating of urges to smoke 24 hours and one week after the target quit date assessed by Mood and Physical Symptoms Scale [ Time Frame: 24 hours and 7 days after quit date ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in pre-quit end-expired carbon monoxide reading (CO) [ Time Frame: 4-weeks after first medication dose ] [ Designated as safety issue: No ]
Change in pre-quit cotinine levels [ Time Frame: 4-weeks after first medication dose ] [ Designated as safety issue: No ]
Change in pre-quit ratings of cigarette satisfaction [ Time Frame: 4-weeks after first medication dose ] [ Designated as safety issue: No ]
Change in pre-quit cigarette consumption [ Time Frame: 4-weeks after first medication dose ] [ Designated as safety issue: No ]
Change in MPSS scores of urges to smoke and cigarette withdrawal symptoms throughout the first four weeks of abstinence [ Time Frame: 4-week after quit date ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	February 2009
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Varenicline pre-treatmemt: Experimental Participants will use varenicline (1mg BD) 4-weeks prior to quitting	Drug: Varenicline Varenicline 1mg twice daily
Placebo: Placebo Comparator Participants will use 3 weeks of placebo, followed by 1 week of varenicline, prior to quitting	Drug: Varenicline Varenicline 1mg twice daily Drug: Placebo Placebo 1mg BD

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Smokers seeking treatment
Aged 18 and over
Consenting to take part in the trial

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 including uncontrolled hypertension and recent cardiac event
Sensitivity to varenicline currently enrolled in other research projects.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00789074

Contacts

Contact: Katie Myers, MSc	+44 20 7377 2663	k.myers@qmul.ac.uk
Contact: Hayden McRobbie	+44 20 7882 8246	hayden.mcrobbie@inspiringlimited.com

Locations

United Kingdom
Tobacco Dependence Research and Treatment Unit
London, United Kingdom, E1 2JH

Sponsors and Collaborators

Queen Mary University of London

Investigators

Principal Investigator:

Peter Hajek, PhD

Queen Mary University of London

More Information

Responsible Party:	Queen Mary University of London ( Professor Peter Hajek )
Study ID Numbers:	qmul120508
Study First Received:	November 7, 2008
Last Updated:	November 10, 2008
ClinicalTrials.gov Identifier:	NCT00789074
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency; United Kingdom: Research Ethics Committee

Keywords provided by Queen Mary University of London:

Smoking cessation
Tobacco dependence
Varenicline
Preloading

Study placed in the following topic categories:

Smoking
Mental Disorders
Tobacco Use Disorder
Substance-Related Disorders
Disorders of Environmental Origin

Additional relevant MeSH terms:

Habits

ClinicalTrials.gov processed this record on January 16, 2009