Exenatide as an adjunct to nicotine patch for smoking cessation and prevention of postcessation weight gain among treatment-seeking smokers with pre-diabetes and/or overweight: study protocol for a randomised, placebo-controlled clinical trial

What Was Tested

This clinical study looks at Therapeutic nicotine (patch, non-peptide) and Exenatide.

Unfortunately, most smokers gain weight after quitting.

Postcessation weight gain (PCWG) is frequently cited as one of the primary barriers to a quit attempt and a common cause of relapse.

Who Took Part

The primary outcomes are 4-week continuous abstinence and changes in body weight at the end of treatment.

The secondary outcomes are (1) abstinence and changes in body weight at 12 weeks post end of treatment and (2) changes in neuroaffective responses to cigarette-related and food-related cues as measured by electroencephalogram.

How the Study Was Run

The researchers set it up as a randomized, double-blind and placebo-controlled 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.

Some participants received a placebo instead of Therapeutic nicotine (patch, non-peptide), giving a reference point.

The study will be conducted at two university-affiliated research sites in Houston, Texas, the UTHealth Center for Neurobehavioral Research on Addiction and Baylor College of Medicine Michael E.

What Was Measured

Postcessation weight gain (PCWG) is frequently cited as one of the primary barriers to a quit attempt and a common cause of relapse.

This report describes the design of a double-blind, placebo-controlled, randomised clinical trial that evaluates the effects of the GLP-1RA exenatide as an adjunct to nicotine patches on smoking abstinence and PCWG.

PubMed files the paper under topics including Overweight, Tobacco Use Cessation Devices, Smoking Cessation, Exenatide, Smokers, Prediabetic State and Nicotine.

Author keywords: clinical trial, obesity and substance misuse.

What This Means in Plain Language

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

The publication is from 2023 (BMJ open), a journal based in England.

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