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Semaglutide for Nicotine Addiction

Phase 2
Recruiting
Led By Christian Hendershot, PhD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (week 0) to study endpoint (week 10)
Awards & highlights

Summary

This trial will examine whether a GLP-1 receptor agonist can reduce nicotine intake and reinstatement in smokers.

Who is the study for?
This trial is for adults aged 21-65 who smoke at least 5 cigarettes daily over the past year without a break of more than 90 days. Participants must have moderate nicotine dependence, be motivated to quit within the next 3-18 months, and willing to take study medication and attend lab sessions involving smoking. Exclusions include those with diabetes, certain medical conditions or histories (like cancer), uncontrolled blood pressure, extreme BMI values, use of conflicting medications or substances, and women who are pregnant or not using effective contraception.Check my eligibility
What is being tested?
The trial tests Semaglutide's effects on nicotine intake among smokers. It's a double-blind study where participants won't know if they're getting Semaglutide or a placebo. The goal is to see if this drug can help reduce cigarette consumption by affecting biological mechanisms related to addiction.See study design
What are the potential side effects?
While specific side effects for this trial aren't listed, common ones for Semaglutide may include nausea, vomiting, diarrhea, abdominal pain and constipation. There could also be potential allergic reactions in those sensitive to the medication.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (week 0) to study endpoint (week 10)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (week 0) to study endpoint (week 10) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Nicotine Reinstatement Duration
Change in Nicotine Self-Administration
Secondary outcome measures
Change in Daily Cigarette Smoking
Other outcome measures
Change in Body Weight
Change in Cigarette Craving
Body Weight Changes
+1 more

Side effects data

From 2020 Phase 4 trial • 104 Patients • NCT04189848
21%
Nausea
12%
Decreased Appetite
100%
80%
60%
40%
20%
0%
Study treatment Arm
Overall Study

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SemaglutideExperimental Treatment1 Intervention
Participants will receive semaglutide via subcutaneous injections at escalating doses (0.25mg to 1.0mg) over 9 weeks.
Group II: Sham/PlaceboPlacebo Group1 Intervention
Participants will receive sham subcutaneous injections over 9 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Semaglutide
2021
Completed Phase 4
~5160

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Tobacco Use Disorder include bupropion, nicotine replacement therapy (NRT), varenicline, and GLP-1 receptor agonists. Bupropion is an antidepressant that inhibits the reuptake of norepinephrine and dopamine, reducing withdrawal symptoms and the urge to smoke. NRT provides a controlled dose of nicotine to ease withdrawal symptoms and reduce cravings. Varenicline is a selective nicotinic acetylcholine receptor agonist that reduces cravings and withdrawal symptoms by partially stimulating nicotine receptors and blocking nicotine from binding. GLP-1 receptor agonists, like semaglutide, are being studied for their potential to reduce nicotine intake and prevent relapse by modulating reward pathways in the brain. Understanding these mechanisms is crucial for patients as it helps tailor treatment plans to individual needs, improving the chances of successful smoking cessation.
The Effects of Smoking Cessation on Diabetes Mellitus Patients.A review of tobacco use treatments in U.S. ethnic minority populations.A randomized trial of bupropion and/or nicotine gum as maintenance treatment for preventing smoking relapse.

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor
1,526 Previous Clinical Trials
4,197,189 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,503 Previous Clinical Trials
2,625,535 Total Patients Enrolled
272 Trials studying Tobacco Use Disorder
48,977 Patients Enrolled for Tobacco Use Disorder
Christian Hendershot, PhDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
1 Previous Clinical Trials
111 Total Patients Enrolled

Media Library

Tobacco Use Disorder Research Study Groups: Sham/Placebo, Semaglutide
~17 spots leftby Jul 2025
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