Semaglutide for Tobacco Dependence

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University of North Carolina, Chapel Hill, NC
Tobacco Dependence+1 More
Semaglutide - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study 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.

Eligible Conditions

  • Tobacco Dependence
  • Nicotine Addiction

Treatment Effectiveness

Study Objectives

2 Primary · 1 Secondary · Reporting Duration: baseline (Week 0) to study endpoint (Week 10)

Week 8
Change in Cigarette Craving
Change in Nicotine Reinstatement Duration
Change in Nicotine Self-Administration
Change in Subjective Responses to Cigarette Smoking
Week 10
Change in Body Weight
Change in Daily Cigarette Smoking
Change in HbA1c

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Overall Study
21%Nausea
12%Decreased Appetite
This histogram enumerates side effects from a completed 2020 Phase 4 trial (NCT04189848) in the Overall Study ARM group. Side effects include: Nausea with 21%, Decreased Appetite with 12%.

Trial Design

2 Treatment Groups

Semaglutide
1 of 2
Sham/Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

48 Total Participants · 2 Treatment Groups

Primary Treatment: Semaglutide · Has Placebo Group · Phase 2

Semaglutide
Drug
Experimental Group · 1 Intervention: Semaglutide · Intervention Types: Drug
Sham/Placebo
Drug
ShamComparator Group · 1 Intervention: Sham/placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Semaglutide
2019
Completed Phase 4
~5140

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline (week 0) to study endpoint (week 10)
Closest Location: University of North Carolina · Chapel Hill, NC
Photo of University of North Carolina at Chapel Hill  1Photo of University of North Carolina at Chapel Hill  2Photo of University of North Carolina at Chapel Hill  3
2007First Recorded Clinical Trial
0 TrialsResearching Tobacco Dependence
373 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
A positive result for smoking status, based on expired CO > 8 at baseline.
You are willing to complete lab sessions involving cigarette smoking.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.