Use of Varenicline for 4-weeks Prior to Quitting

• ClinicalTrials.gov Identifier: NCT00789074
• Recruitment Status: Completed
• First Posted: November 11, 2008
• Results First Posted: June 25, 2012
• Last Update Posted: December 12, 2013
• Sponsor: Queen Mary University of London
• Information provided by (Responsible Party): Professor Peter Hajek, Queen Mary University of London

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Tobacco Dependence; Smoking Cessation	Drug: Varenicline; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 101 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effects of an Extended Period of Varenicline Use Prior to Quitting Smoking on Post-quitting Urges to Smoke
• Study Start Date: July 2009
• Actual Primary Completion Date: December 2009
• Actual Study Completion Date: March 2010

Arms and Interventions

Arm	Intervention/treatment
Experimental: Varenicline pre-treatmemt; Participants will use varenicline (1mg BD) 4-weeks prior to quitting	Drug: Varenicline; Varenicline 1mg twice daily; Other Name: Champix
Placebo Comparator: Placebo; Participants will use 3 weeks of placebo, followed by 1 week of varenicline, prior to quitting	Drug: Varenicline; Varenicline 1mg twice daily; Other Name: Champix; Drug: Placebo; Placebo 1mg BD

Outcome Measures

Primary Outcome Measures :

1. 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 (week 4) ]
   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.

Secondary Outcome Measures :

1. Change in Pre-quit End-expired Carbon Monoxide Reading (CO) [ Time Frame: Baseline - week 8 ]

   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.

2. Change in Pre-quit Cotinine Levels [ Time Frame: Weeks 1-4 (the first 4-weeks after first medication dose) ]
   Differences in baseline cotinine levels were compared with cotinine levels measured 4 weeks after taking the first medication dose.
3. Change in Pre-quit Ratings of Cigarette Satisfaction [ Time Frame: Baseline - week 4 ]
   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
4. Change in Pre-quit Cigarette Consumption [ Time Frame: Baseline - week 4 ]
   Participants reported average number of cigarettes smoked per day every week throughout the four week pre-quit period.
5. Change in MPSS Scores of Urges to Smoke and Cigarette Withdrawal Symptoms Throughout the First Four Weeks of Abstinence [ Time Frame: Week 4 - 8 ]

   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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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: Al-Rehan A A Dhanji, MB BS BSc MRCP; Queen Mary University of London

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Professor Peter Hajek, Professor of Clinical Psychology, Queen Mary University of London
• ClinicalTrials.gov Identifier: NCT00789074
• Other Study ID Numbers: qmul120508
• First Posted: November 11, 2008
• Results First Posted: June 25, 2012
• Last Update Posted: December 12, 2013
• Last Verified: November 2013

Keywords provided by Professor Peter Hajek, Queen Mary University of London:

Smoking cessation; Tobacco dependence; Varenicline; Preloading

Additional relevant MeSH terms:

Tobacco Use Disorder; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Varenicline; Nicotinic Agonists; Cholinergic Agonists; Cholinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs