Study S001464

A Randomized Controlled Trial of Exenatide as an Adjunct to Nicotine Patch for Smoking Cessation and Prevention of Post-Cessation Weight Gain

Name: LivingGLP1 adjudicated trial data and network meta-analysis results
Creator: Ahmad Sofi-Mahmudi
License: https://creativecommons.org/licenses/by/4.0/

ClinicalTrials.gov record

Registration

Registration: NCT05610800
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE2
Masking: DOUBLE
Status: COMPLETED
Enrollment: 140
Start: 2022-12-07
Primary completion: 2025-11-07
Lead sponsor: The University of Texas Health Science Center, Houston
Conditions: Smoking Cessation; Weight Gain
Interventions: DRUG:Exenatide 2 milligram (mg) Injection; DRUG:Placebo; DRUG:Nicotine patch; BEHAVIORAL:Smoking Cessation Counseling
Results posted: FALSE
Individual participant data sharing: NO

Registered primary outcomes

Percentage of participants with 4-week continuous abstinence at 12 weeks post-target quit day as assessed by self-report timeline followback (TLFB) and verified by breath carbon monoxide (CO) level [Week 15]
Weight change in kilograms at 12 weeks post-target quit day [Baseline, Week 15]

Linked records (2)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0012889	Targeting GLP-1 receptors to reduce nicotine use disorder: Preclinical and clinical evidence. Herman RJ, Physiology & behavior	2024	Narrative review	PMID 38663460 DOI	cites ClinicalTrials.gov:NCT05610800; registry reference DERIVED:38663460
R0008025	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. Yammine L, BMJ open	2023	Protocol	PMID 37316311 DOI	cites ClinicalTrials.gov:NCT05610800; registry reference DERIVED:37316311