Use of Varenicline for 4-weeks Prior to Quitting

Queen Mary University of London

Status and phase: Completed; Phase 3

Conditions: Tobacco Dependence; Smoking Cessation

Treatments: Drug: Varenicline; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00789074

qmul120508

Details and patient eligibility

About

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.

Enrollment: 101 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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101 participants in 2 patient groups, including a placebo group

Varenicline pre-treatmemt

Experimental group

Description:

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

Treatment:

Drug: Varenicline

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Drug: Varenicline