Use of Varenicline for 4-weeks Prior to Quitting

Smoking Cessation Clinical Trial

Official title:

Effects of an Extended Period of Varenicline Use Prior to Quitting Smoking on Post-quitting Urges to Smoke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00789074
• Other study ID #: qmul120508
• Status: Completed
• Phase: Phase 3
• First received: November 7, 2008
• Last updated: November 18, 2013
• Start date: July 2009
• Est. completion date: March 2010

Study information

• Verified date: November 2013
• Source: Queen Mary University of London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: March 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking Cessation
• Tobacco Dependence
• Tobacco Use Disorder

Intervention

Drug:
• Varenicline
Varenicline 1mg twice daily
• Placebo
Placebo 1mg BD

Locations

Country	Name	City	State
United Kingdom	Tobacco Dependence Research and Treatment Unit	London

Sponsors (1)

Lead Sponsor	Collaborator
Queen Mary University of London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rating of Urges to Smoke 24 Hours and One Week After the Target Quit Date Assessed by Mood and Physical Symptoms Scale	The scale measures tobacco withdrawal symptoms (depressed, irritable, restless, hungry, poor concentration, slept worse than usual) on 5-point scales from Not at all (rated as 1) to Extremely (rated as 5). It also asks 'How much of the time have you felt the urge to smoke in the last week? and 'How strong have these urges been?'; both rated on 6-point scales with higher numbers=higher craving.	24 hours and 7 days after quit date (week 4)	No
Secondary	Change in Pre-quit End-expired Carbon Monoxide Reading (CO)	Carbon monoxide concentration is measured in particles per million. It indicates smoke intake.; CO was measured at each contact to monitor changes in smoke intake and differences between the study arms.	Baseline - week 8	No
Secondary	Change in Pre-quit Cotinine Levels	Differences in baseline cotinine levels were compared with cotinine levels measured 4 weeks after taking the first medication dose.	Weeks 1-4 (the first 4-weeks after first medication dose)	No
Secondary	Change in Pre-quit Ratings of Cigarette Satisfaction	Satisfaction measured on a scale of 1-5; "Have you found your cigarettes more or less enjoyable than usual in the last week?" 1= much more and 5 = much less	Baseline - week 4	No
Secondary	Change in Pre-quit Cigarette Consumption	Participants reported average number of cigarettes smoked per day every week throughout the four week pre-quit period.	Baseline - week 4	No
Secondary	Change in MPSS Scores of Urges to Smoke and Cigarette Withdrawal Symptoms Throughout the First Four Weeks of Abstinence	Change in the Mood and Physical Symptoms Scale (MPSS)*, scores of urges to smoke and cigarette withdrawal symptoms throughout the first four weeks of abstinence (measured weekly from weeks 4-8).; * The MPSS measures cigarette withdrawal symptoms. The scale is 1-5, 1 being not at all and 5 being extremely (depressed, irritable, restless, hungry, poor concentration, slept worse than usual).	Week 4 - 8	No