Combination of Nicotine Replacement Therapy (NRT) and Varenicline to Increase Cessation of Tobacco (CONVICT Study) (CONVICT)

October 10, 2012 updated by: Professor Peter Hajek, Queen Mary University of London

Effects of a Combination of Varenicline and Transdermal Nicotine Patch on Post-quitting Urges to Smoke

Varenicline and nicotine replacement therapy (NRT) are both effective smoking cessation treatments. Anecdotally smokers who are finding their quit attempt difficult have reported benefiting from adding NRT to varenicline. This proof-of-principle placebo-controlled double-blind study will examine whether combining NRT and varenicline provides better withdrawal and craving relief than varenicline alone. A total of 120 smokers would be randomised to receive varenicline +15mg/16hr patch or varenicline + placebo patch. All participants will receive standard NHS Stop Smoking Service support. The primary outcome would be ratings of craving and withdrawal discomfort 24 hours and one week after the target quit date.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

117

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, E1 2JH
        • Tobacco Dependence Research Unit
      • London, United Kingdom, E1 2JH
        • Tobacco Dependence Research and Treatment Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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
  • Unable to fill in questionnaires in English
  • Previous allergy to Varenicline
  • Previous allergy to Nicotine Patches Previous allergy to varenicline

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Varenicline + Active Patch
Participants will use varenicline (1mg BD) + an active, 15mg/16hr Nicotine Patch
Drug: Nicotine Patch
Varenicline + nicotine patch
Other Names:
  • Champix
  • Chantix
Drug: Varenicline
All participants will receive a standard dose of varenicline (12 weeks).
Other Names:
  • Champix
  • Chantix
Placebo Comparator: Varenicline + Placebo Patch
Participants will use varenicline (1mg BD) + a Placebo Nicotine Patch
Drug: Varenicline
All participants will receive a standard dose of varenicline (12 weeks).
Other Names:
  • Champix
  • Chantix
Drug: Placebo
Varenicline + placebo patch
Other Names:
  • Champix
  • Chantix

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rating of urges to smoke one week after the target quit date assessed by Mood and Physical Symptoms Scale
Time Frame: 1 week
Rating of urges to smoke will be assessed using the Mood and Physical Symptoms Scale
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validated abstinence rates over weeks 1-12 post target quit date
Time Frame: 12 weeks post target quit date
12 weeks post target quit date
Rating of withdrawal symptoms up to 4-weeks post quitting assessed by Mood and Physical Symptoms Scale
Time Frame: 4-weeks post quitting
4-weeks post quitting
Profile of all adverse effects reported up to 12-weeks post quitting
Time Frame: Up to 12-weeks post quitting
Up to 12-weeks post quitting
Ratings of urges to smoke 24 hours after the target quit date
Time Frame: 24 hours
Urges to smoke at 24 hours after the target quit date will be assessed using the Mood & Physical Symptoms Scale
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen Mary University of London

Investigators

  • Principal Investigator: Al-Rehan A A Dhanji, MB BS BSc MRCS, Queen Mary University of London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

August 17, 2010

First Submitted That Met QC Criteria

August 18, 2010

First Posted (Estimate)

August 19, 2010

Study Record Updates

Last Update Posted (Estimate)

October 11, 2012

Last Update Submitted That Met QC Criteria

October 10, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • qmul250510
  • 2010-022334-92 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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