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

Phase 3

Completed

• Conditions: Tobacco Dependence; Smoking Cessation
• Interventions: Drug: Nicotine Patch; Drug: Placebo; Drug: Varenicline

• Registration Number: NCT01184664
• Lead Sponsor: Queen Mary University of London

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-08-17
• Study First Submitted QC: 2010-08-18
• Study First Posted: 2010-08-19
• Study Start: 2011-04
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-10
• Last Update Posted: 2012-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 117

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Varenicline + Active Patch	Varenicline	Participants will use varenicline (1mg BD) + an active, 15mg/16hr Nicotine Patch
Varenicline + Active Patch	Nicotine Patch	Participants will use varenicline (1mg BD) + an active, 15mg/16hr Nicotine Patch
Varenicline + Placebo Patch	Placebo	Participants will use varenicline (1mg BD) + a Placebo Nicotine Patch
Varenicline + Placebo Patch	Varenicline	Participants will use varenicline (1mg BD) + a Placebo Nicotine Patch

Primary Outcome Measures

Name	Time	Method
Rating of urges to smoke one week after the target quit date assessed by Mood and Physical Symptoms Scale	1 week	Rating of urges to smoke will be assessed using the Mood and Physical Symptoms Scale

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Tobacco Dependence Research Unit; 🇬🇧 London, United Kingdom

Tobacco Dependence Research and Treatment Unit; 🇬🇧 London, United Kingdom