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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
117
Varenicline + nicotine patch
Varenicline + placebo patch
All participants will receive a standard dose of varenicline (12 weeks).
Tobacco Dependence Research and Treatment Unit
London, United Kingdom
Tobacco Dependence Research Unit
London, United Kingdom
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
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