drugset / Trial / NCT05530577

Effects of Semaglutide on Nicotine Intake

NCT05530577 ↗

RandomizedParallel-groupTriple-blindBasic science

Summary

Tobacco use remains the foremost cause of preventable deaths in the U.S. and worldwide. Advancing new smoking cessation therapies, including those targeting novel biological mechanisms, is a critical public health priority. Accumulating evidence from preclinical studies suggests that glucagon-like peptide-1 (GLP-1) receptor agonists reduce intake and/or reinstatement of addictive drugs, including nicotine. However, translational work is necessary to establish whether GLP-1 receptor agonists alter aspects of nicotine response and smoking behavior in smokers. Human laboratory studies play a pivotal role in drug development by providing a time- and cost-efficient means of validating preclinical findings, also providing an ideal platform for studying mechanisms of medication effects. This is an experimental investigation to examine the effects of an approved GLP-1 receptor agonist on nicotine intake and reinstatement. Dependent smokers will be enrolled in a double-blind, parallel-arm trial with laboratory endpoints. Laboratory procedures will include a validated procedure for measuring smoking lapse/reinstatement after overnight abstinence. This study will provide initial laboratory evidence for the potential efficacy of GLP-1 receptor agonists as adjunctive treatments for smoking cessation.

Timeline

Start
2022-10-07
Primary completion
2024-05-13
Completion
2024-05-13

Outcome

Missed primary endpoint

paper Primary treatment-by-time interactions on laboratory measures of smoking resistance (23 participants; β = 0.16 [95% CI, -0.07 to 0.40]; P = .16) and number of cigarettes (22 participants; β = -0.08 [95% CI, -0.25 to 0.08]; P = .30) were not significant. PMID 42189538 ↗

paper semaglutide monotherapy did not significantly increase laboratory smoking resistance or reduce weekly cigarettes per day PMID 42189538 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Semaglutide Peptide 0.5 mg Subcutaneous

Indications