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

Primary Purpose

Tobacco Dependence, Smoking Cessation

Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Nicotine Patch
Placebo
Varenicline
Sponsored by
Queen Mary University of London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Dependence focused on measuring Smoking cessation, Tobacco dependence, Varenicline, Nicotine Replacement Therapy, Combination therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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
  • Unable to fill in questionnaires in English
  • Previous allergy to Varenicline
  • Previous allergy to Nicotine Patches Previous allergy to varenicline

Sites / Locations

  • Tobacco Dependence Research and Treatment Unit
  • Tobacco Dependence Research Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Varenicline + Active Patch

Varenicline + Placebo Patch

Arm Description

Participants will use varenicline (1mg BD) + an active, 15mg/16hr Nicotine Patch

Participants will use varenicline (1mg BD) + a Placebo Nicotine Patch

Outcomes

Primary Outcome Measures

Rating of urges to smoke one week after the target quit date assessed by Mood and Physical Symptoms Scale
Rating of urges to smoke will be assessed using the Mood and Physical Symptoms Scale

Secondary Outcome Measures

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

Full Information

First Posted
August 17, 2010
Last Updated
October 10, 2012
Sponsor
Queen Mary University of London
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1. Study Identification

Unique Protocol Identification Number
NCT01184664
Brief Title
Combination of Nicotine Replacement Therapy (NRT) and Varenicline to Increase Cessation of Tobacco (CONVICT Study)
Acronym
CONVICT
Official Title
Effects of a Combination of Varenicline and Transdermal Nicotine Patch on Post-quitting Urges to Smoke
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen Mary University of London

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Dependence, Smoking Cessation
Keywords
Smoking cessation, Tobacco dependence, Varenicline, Nicotine Replacement Therapy, Combination therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
117 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Varenicline + Active Patch
Arm Type
Experimental
Arm Description
Participants will use varenicline (1mg BD) + an active, 15mg/16hr Nicotine Patch
Arm Title
Varenicline + Placebo Patch
Arm Type
Placebo Comparator
Arm Description
Participants will use varenicline (1mg BD) + a Placebo Nicotine Patch
Intervention Type
Drug
Intervention Name(s)
Nicotine Patch
Other Intervention Name(s)
Champix, Chantix
Intervention Description
Varenicline + nicotine patch
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Champix, Chantix
Intervention Description
Varenicline + placebo patch
Intervention Type
Drug
Intervention Name(s)
Varenicline
Other Intervention Name(s)
Champix, Chantix
Intervention Description
All participants will receive a standard dose of varenicline (12 weeks).
Primary Outcome Measure Information:
Title
Rating of urges to smoke one week after the target quit date assessed by Mood and Physical Symptoms Scale
Description
Rating of urges to smoke will be assessed using the Mood and Physical Symptoms Scale
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Validated abstinence rates over weeks 1-12 post target quit date
Time Frame
12 weeks post target quit date
Title
Rating of withdrawal symptoms up to 4-weeks post quitting assessed by Mood and Physical Symptoms Scale
Time Frame
4-weeks post quitting
Title
Profile of all adverse effects reported up to 12-weeks post quitting
Time Frame
Up to 12-weeks post quitting
Title
Ratings of urges to smoke 24 hours after the target quit date
Description
Urges to smoke at 24 hours after the target quit date will be assessed using the Mood & Physical Symptoms Scale
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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 Unable to fill in questionnaires in English Previous allergy to Varenicline Previous allergy to Nicotine Patches Previous allergy to varenicline
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Al-Rehan A A Dhanji, MB BS BSc MRCS
Organizational Affiliation
Queen Mary University of London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tobacco Dependence Research and Treatment Unit
City
London
ZIP/Postal Code
E1 2JH
Country
United Kingdom
Facility Name
Tobacco Dependence Research Unit
City
London
ZIP/Postal Code
E1 2JH
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
23718718
Citation
Hajek P, Smith KM, Dhanji AR, McRobbie H. Is a combination of varenicline and nicotine patch more effective in helping smokers quit than varenicline alone? A randomised controlled trial. BMC Med. 2013 May 29;11:140. doi: 10.1186/1741-7015-11-140.
Results Reference
derived

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

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