Efficacy and safety of a nicotine mouth spray for smoking cessation; a randomized, multicenter, controlled study in a naturalistic setting (original) (raw)

Background Nicotine replacement therapy (NRT) has been demonstrated to be an effective pharmacological treatment for smoking cessation, and most types of NRT have been approved as over-the-counter (OTC) medications. In an effort to create a fast-acting, flexible and discreet NRT, a nicotine mouth spray (NMS) has been developed. This study was designed to assess the efficacy and safety of NMS in a naturalistic setting in the United States. Methods This was a multicenter, randomized, double-blind, placebo-controlled, parallel group, 26-week study in 1198 smokers motivated to quit. The study was designed to resemble an OTC environment, and thus included limited intervention, limited motivational screening, and no behavioral support. The primary efficacy endpoint was carbon monoxide (CO) verified, self-reported continuous abstinence from smoking from Week 2 until Week 6. The safety of NMS was assessed by measuring vital signs, visual mouth inspection, and collection of subject-reported ...