Use of Varenicline for 4-weeks Prior to Quitting

NCT00789074 | Completed Phase 3 Results

• 1 other identifier: qmul120508
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tobacco Dependence; Smoking Cessation

Keywords

Smoking cessation; Tobacco dependence; Varenicline; Preloading

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (5)

• Change in Pre-quit End-expired Carbon Monoxide Reading (CO)

  Baseline - week 8

• Change in Pre-quit Cotinine Levels

  Weeks 1-4 (the first 4-weeks after first medication dose)

• Change in Pre-quit Ratings of Cigarette Satisfaction

  Baseline - week 4

• Change in Pre-quit Cigarette Consumption

  Baseline - week 4

• Change in MPSS Scores of Urges to Smoke and Cigarette Withdrawal Symptoms Throughout the First Four Weeks of Abstinence

  Week 4 - 8

Study Arms (2)

Varenicline pre-treatmemt

EXPERIMENTAL

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

Drug: Varenicline

Placebo

PLACEBO COMPARATOR

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

Drug: Varenicline; Drug: Placebo

Interventions

Varenicline DRUG

Varenicline 1mg twice daily

Also known as: Champix

Placebo; Varenicline pre-treatmemt

Placebo DRUG

Placebo 1mg BD

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Queen Mary University of London: lead

Study Sites (1)

Tobacco Dependence Research and Treatment Unit

London, E1 2JH, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 37142273 DERIVED

• 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.

  PMID: 21518946 DERIVED

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking Cessation

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Results Point of Contact

• Title: Professor Peter Hajek
• Organization: Queen Mary University of London

p.hajek@qmul.ac.uk

+44 207 882 8231

Study Officials

• Al-Rehan A A Dhanji, MB BS BSc MRCP

  Queen Mary University of London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical Psychology

Study Record Dates

• First Submitted: November 7, 2008
• First Posted: November 11, 2008
• Study Start: July 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: March 1, 2010
• Last Updated: December 12, 2013
• Results First Posted: June 25, 2012

Record last verified: 2013-11

Locations

GB (1)