drugset / Trial / NCT01184664

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

NCT01184664

Phase 3 Completed 117 enrolled Queen Mary University of London
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2011-04
Primary completion
2011-10
Completion
2011-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Nicotine Unknown 15 mg Other
Background Varenicline Small molecule 1 mg

Indications