NCT01184664

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: Queen Mary University of London · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Tobacco Dependence
• Smoking Cessation

Interventions

Type	Name	Description
DRUG	Nicotine Patch	Varenicline + nicotine patch
DRUG	Placebo	Varenicline + placebo patch
DRUG	Varenicline	All participants will receive a standard dose of varenicline (12 weeks).

Timeline

• Start date: 2011-04-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2010-08-19
• Last updated: 2012-10-11

Locations

2 sites across 1 country: United Kingdom