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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
24
Semaglutide (subcutaneous)
Sham subcutaneous injection
University of North Carolina
Chapel Hill, North Carolina, United States
Change in Nicotine Self-Administration
Number of cigarettes smoked during a laboratory smoking procedure
Time frame: Baseline (Week 0) to post-medication (Week 8)
Change in Nicotine Reinstatement Duration
Duration (minutes) of resistance to smoking reinstatement during a laboratory lapse task
Time frame: Baseline (Week 0) to post-medication (Week 8)
Change in Daily Cigarette Smoking
Number of cigarettes consumed per day during medication exposure
Time frame: Baseline (Week 0) to study endpoint (Week 10)
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