What side effects are associated with this type of intervention?

Common treatments for Tobacco Use Disorder include varenicline, bupropion, and nicotine replacement therapies (NRTs). Varenicline can cause side effects such as nausea, insomnia, and abnormal dreams. Bupropion is associated with insomnia, dry mouth, and an increased risk of seizures. Nicotine replacement therapies, including patches, gum, and lozenges, may cause local irritation, insomnia, and vivid dreams. While GLP-1 receptor agonists like semaglutide are being studied for their potential to reduce nicotine intake, they are known to cause gastrointestinal side effects such as nausea and vomiting.

What prior FDA approvals exist?

The FDA has approved several pharmacotherapies for the treatment of Tobacco Use Disorder, including nicotine replacement therapies (NRTs) like patches, gums, and lozenges, as well as non-nicotine medications such as bupropion and varenicline. Bupropion is a nicotinic antagonist that helps reduce withdrawal symptoms and the urge to smoke, while varenicline works by partially stimulating nicotine receptors to reduce cravings and withdrawal symptoms. Although GLP-1 receptor agonists, such as semaglutide, are being studied for their potential to reduce nicotine intake and reinstatement, they are not yet approved by the FDA specifically for smoking cessation.

What other types of research exist?

Promising novel alternatives to GLP-1 receptor agonists for treating tobacco use disorder in 2024 include varenicline, bupropion, and nicotine replacement therapies. These treatments have demonstrated efficacy and safety in multiple clinical trials. Additionally, ongoing research into other pharmacological agents and behavioral interventions may provide new options in the near future.

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Semaglutide for Nicotine Addiction

Phase 2

Waitlist Available

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)

Summary

This trial is testing a medication to help smokers quit by reducing cravings for nicotine. The study will involve smokers who are addicted to nicotine and will measure their smoking behavior after using the medication.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (week 0) to study endpoint (week 10)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Nicotine Reinstatement Duration

Change in Nicotine Self-Administration

Secondary study objectives

Change in Daily Cigarette Smoking

Other study objectives

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%

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

Do I qualify?Apply below to find out

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.