NCT05530577

Effects of Semaglutide on Nicotine Intake

Effects of Semaglutide on Nicotine Intake and Smoking Lapse

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Tobacco Use Disorder
• Nicotine Addiction

Interventions

Type	Name	Description
DRUG	Semaglutide	Semaglutide (subcutaneous)
DRUG	Sham/placebo	Sham subcutaneous injection

Timeline

• Start date: 2022-10-07
• Primary completion: 2024-05-13
• Completion: 2024-05-13
• First posted: 2022-09-07
• Last updated: 2025-08-22
• Results posted: 2025-07-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study