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Use of Varenicline for 4-weeks Prior to Quitting

NCT ID: NCT00789074

Last Updated: 2013-12-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Tobacco Dependence Smoking Cessation

Keywords

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Smoking cessation Tobacco dependence Varenicline Preloading

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Varenicline pre-treatmemt

Participants will use varenicline (1mg BD) 4-weeks prior to quitting

Group Type EXPERIMENTAL

Varenicline

Intervention Type DRUG

Varenicline 1mg twice daily

Placebo

Participants will use 3 weeks of placebo, followed by 1 week of varenicline, prior to quitting

Group Type PLACEBO_COMPARATOR

Varenicline

Intervention Type DRUG

Varenicline 1mg twice daily

Placebo

Intervention Type DRUG

Placebo 1mg BD

Interventions

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Varenicline

Varenicline 1mg twice daily

Intervention Type DRUG

Placebo

Placebo 1mg BD

Intervention Type DRUG

Other Intervention Names

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Champix

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Queen Mary University of London

OTHER

Sponsor Role lead

Responsible Party

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Professor Peter Hajek

Professor of Clinical Psychology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Al-Rehan A A Dhanji, MB BS BSc MRCP

Role: PRINCIPAL_INVESTIGATOR

Queen Mary University of London

Locations

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Tobacco Dependence Research and Treatment Unit

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.

Reference Type DERIVED
PMID: 37142273 (View on PubMed)

Hajek P, McRobbie HJ, Myers KE, Stapleton J, Dhanji AR. Use of varenicline for 4 weeks before quitting smoking: decrease in ad lib smoking and increase in smoking cessation rates. Arch Intern Med. 2011 Apr 25;171(8):770-7. doi: 10.1001/archinternmed.2011.138.

Reference Type DERIVED
PMID: 21518946 (View on PubMed)

Other Identifiers

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qmul120508

Identifier Type: -

Identifier Source: org_study_id