Efficacy and Safety of a Nicotine Mouth Spray for Smoking Cessation: A Randomized, Multicenter, Controlled Study in a Naturalistic Setting.

What Was Tested

The paper reports a study of Therapeutic nicotine (patch, non-peptide), published as a randomized controlled trial.

In an effort to create a fast-acting, flexible, and discreet NRT, a nicotine mouth spray (NMS) has been developed.

Who Took Part

The age groups tagged for this paper are middle-aged adults, both men and women.

The study was designed to resemble an OTC environment, and thus included limited intervention, limited motivational screening, and no behavioral support.

The safety of NMS was assessed by measuring vital signs, visual mouth inspection, and collection of subject-reported adverse events (AEs).

How the Study Was Run

In design terms this was a randomized, double-blind, placebo-controlled, multicenter and parallel-group study.

The participants were allocated by chance, so the Therapeutic nicotine (patch, non-peptide) group and the comparison group should start out alike.

As a double-blind Therapeutic nicotine (patch, non-peptide) study, the assignments were hidden from both participants and investigators until the end.

A placebo (an inactive look-alike) gave the Therapeutic nicotine (patch, non-peptide) group a baseline to be compared against.

Running at several centres spread the Therapeutic nicotine (patch, non-peptide) study over different clinics and patient groups.

This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group, 26-week study in 1198 smokers motivated to quit.

What Was Measured

Topics PubMed links to this paper include Carbon Monoxide, Counseling, Nicotine, Nicotinic Agonists, Smoking, Smoking Cessation and Tobacco Use Cessation Devices.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Therapeutic nicotine (patch, non-peptide).

The abstract goes on to report its results in about 7 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2020 (Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco), a journal based in England.

More context: the Therapeutic nicotine (patch, non-peptide) compound page, all human trials.