A Phase 3 interventional study of Nicotine Patch and Placebo in Tobacco Dependence and Smoking Cessation, sponsored by Queen Mary University of London. Completed at 2 sites in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-10-11.
Sponsored by Queen Mary University of London · Phase 3, Interventional, and Treatment
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.
968 studies on the registry are indexed under Tobacco Use Disorder; 126 are open to participants now.
This study's enrollment of 117 is above the median of 89 across 851 interventional studies indexed under Tobacco Use Disorder.
Browse Tobacco Use Disorder studies →Queen Mary University of London is the lead sponsor of 250 studies on the registry; 59 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will use varenicline (1mg BD) + an active, 15mg/16hr Nicotine Patch
Drug: Nicotine Patch · Drug: Varenicline
Participants will use varenicline (1mg BD) + a Placebo Nicotine Patch
Drug: Placebo · Drug: Varenicline
Varenicline + nicotine patch
Also known as: Champix, Chantix
Varenicline + placebo patch
Also known as: Champix, Chantix
All participants will receive a standard dose of varenicline (12 weeks).
Also known as: Champix, Chantix
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
Time frame: 1 week
Validated abstinence rates over weeks 1-12 post target quit date
Time frame: 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
Profile of all adverse effects reported up to 12-weeks post quitting
Time frame: 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
Time frame: 24 hours
This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.
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Queen Mary University of London