Study S000115

Smoking Cessation Facilitated by Glucagon-like Peptide-1 (GLP-1) Analogues - a Randomized, Double-blind, Placebo-controlled Trial

Included trial: extracted data ClinicalTrials.gov record Study Protocol and Statistical Analysis Plan: Substudy "SKIP-Energy" (PDF)Study Protocol: Appendix 4_SKIP Energy_V1_13_10_17 (PDF)Study Protocol: Appendix 5_SKIP_Substudy fMRI (PDF)

Registration

Registration: NCT03204396
Acronym: SKIP
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE2
Masking: QUADRUPLE
Status: COMPLETED
Enrollment: 256
Start: 2017-06-26
Primary completion: 2022-07-30
Lead sponsor: University Hospital, Basel, Switzerland
Conditions: Glucagon-like Peptide-1; Smoking Cessation; Weight Change, Body; Craving
Interventions: DRUG:Dulaglutide; DRUG:0.5 ml normal saline (0.9% sodium chloride [0.9% NaCl])
Results posted: FALSE
Individual participant data sharing: NO
Secondary identifiers: NIH:2017

Registered primary outcomes

Point prevalence abstinence rate at week 12 [12 weeks]

Linked records (6)

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
R0010671	Blood pressure changes during smoking cessation in a randomized, double-blind, placebo-controlled trial of dulaglutide treatment. Beck J, European journal of preventive cardiology	2025	Randomized trial	PMID 40037282 DOI	cites ClinicalTrials.gov:NCT03204396; registry reference DERIVED:40037282
R0014908	Effect of dulaglutide in promoting abstinence during smoking cessation: 12-month follow-up of a single-centre, randomised, double-blind, placebo-controlled, parallel group trial. Lüthi H, EClinicalMedicine	2024	Randomized trial	PMID 38371479 DOI	cites ClinicalTrials.gov:NCT03204396; registry reference DERIVED:38371479
R0010375	Glucagon-like peptide-1 analogues: a new way to quit smoking? (SKIP)-a structured summary of a study protocol for a randomized controlled study. Lengsfeld S, Trials	2023	Protocol	PMID 37081574 DOI	cites ClinicalTrials.gov:NCT03204396; registry reference DERIVED:37081574
R0011101	Effects of dulaglutide on alcohol consumption during smoking cessation. Probst L, JCI insight	2023	Randomized trial	PMID 37991022 DOI	cites ClinicalTrials.gov:NCT03204396; registry reference DERIVED:37991022
R0014721	Effect of dulaglutide in promoting abstinence during smoking cessation: a single-centre, randomized, double-blind, placebo-controlled, parallel group trial. Lengsfeld S, EClinicalMedicine	2023	Randomized trial	PMID 36874396 DOI	cites ClinicalTrials.gov:NCT03204396; registry reference DERIVED:36874396
R0019117	Gender differences in weight gain during attempted and successful smoking cessation on dulaglutide treatment: a predefined secondary analysis of a randomised trial. Baur F, BMJ nutrition, prevention & health	2023	Randomized trial	PMID 38264360 DOI	cites ClinicalTrials.gov:NCT03204396; registry reference DERIVED:38264360