Semaglutide for Smoking Addiction

(GLP1-SC Trial)

Overseen By Nidhi Agrawal

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Ottawa Heart Institute Research Corporation

Must not be taking: NRT, GLP1 RA, Bupropion, others

Disqualifiers: Pregnancy, Type I diabetes, Renal failure, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 6 months

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how well semaglutide, a medication for type 2 diabetes, aids in smoking cessation for individuals with the condition. Researchers aim to determine if combining semaglutide with nicotine replacement therapy (NRT) facilitates quitting smoking. The study includes two groups: one using only NRT and another using semaglutide plus NRT for up to six months. Suitable candidates for this trial are Ontario residents with type 2 diabetes who smoke at least five cigarettes daily and wish to quit. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial requires that you stop using certain medications like bupropion, cytisine, varenicline, and DPP-IV inhibitors at least 7 days before starting. If you're currently using NRT or GLP-1 receptor agonists daily, you cannot participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that semaglutide is generally safe for people. Studies have found that those taking semaglutide have a lower chance of needing medical help for tobacco use disorder (TUD) compared to those using other diabetes drugs, suggesting fewer serious side effects related to smoking issues.

Other research has linked semaglutide to a reduced need for prescriptions to help quit smoking. This might indicate that it helps lessen smoking-related health problems, potentially lowering the risk of side effects from smoking.

The FDA has already approved semaglutide for treating diabetes, which supports its safety. While side effects can occur, the available data supports its safety in aiding smoking cessation. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for smoking addiction?

Unlike the standard treatments for smoking addiction, which typically involve nicotine replacement therapy (NRT) like patches or gum, semaglutide brings a fresh approach. Semaglutide is a medication originally used for diabetes and weight loss, and it works by affecting the brain's reward system, potentially reducing cravings for nicotine. Researchers are excited because this could offer a dual-action benefit—addressing both addiction and potentially aiding in weight management, which is often a concern for those trying to quit smoking. This innovative mechanism has the potential to enhance the effectiveness of traditional therapies, providing a new hope for smokers looking to quit.

What evidence suggests that semaglutide might be an effective treatment for smoking addiction?

Research has shown that semaglutide might help people stop smoking. In this trial, participants in the intervention arm will receive semaglutide combined with combination nicotine replacement therapy (NRT) for up to 6 months. One study found that people using semaglutide were less likely to need medical help for tobacco addiction and required fewer medications to quit smoking. This suggests that semaglutide might help reduce cravings and withdrawal symptoms. These findings are promising for using semaglutide to help people quit smoking, especially those with diabetes. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults in Ontario with type 2 diabetes who smoke at least five cigarettes a day and want to cut down or quit within six months. Participants must have stable blood sugar levels, not have used GLP-1 drugs recently, and be able to give consent.

Inclusion Criteria

I am an adult with type 2 diabetes.

I currently live in Ontario.

I smoke at least five cigarettes daily and want to cut down or quit in 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Semaglutide + Combination NRT or Combination NRT alone for smoking cessation

6 months

Monthly visits (in-person or virtual)

Follow-up

Participants are monitored for smoking cessation and glycemic control

6 months

2 visits (in-person)

Extended Follow-up

Participants are monitored for long-term effects on smoking cessation and glycemic control

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Semaglutide

Trial Overview

The study tests if adding semaglutide (a diabetes medication) to standard nicotine replacement therapy helps people with type 2 diabetes quit smoking better than nicotine replacement alone. Participants are randomly assigned to different groups.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 2 Interventions

Semaglutide + Combination NRT for up to 6 months

Group II: Control Active Control 1 Intervention

Combination NRT for up to 6 months

Who Is Running the Clinical Trial?

Ottawa Heart Institute Research Corporation

Lead Sponsor

Trials

200

Recruited

95,800+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39074369/

Association of Semaglutide With Tobacco Use Disorder in ...

Semaglutide was associated with reduced smoking cessation medication prescriptions and counseling. Similar findings were observed in patients with and ...

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1551714425001831

A randomized controlled trial of once-weekly semaglutide ...

We anticipate that semaglutide 2.4 mg once-weekly will provide a clinically meaningful effect on weight management in the context of smoking cessation. If our ...

3.

acpjournals.org

acpjournals.org/doi/10.7326/acpd-20240809_8

Semaglutide shows promise for smoking cessation

New use of semaglutide was associated with a lower risk for medical care related to tobacco use disorder compared with seven other diabetes ...

4.

cdn.clinicaltrials.gov

cdn.clinicaltrials.gov/large-docs/77/NCT05530577/Prot_SAP_002.pdf

Effects of Semaglutide on Nicotine Intake and Smoking ...

Overall, this study aims to generate initial data on the efficacy of semaglutide in a sample of smokers who are not actively engaged in a quit.

5.

respiratory-therapy.com

respiratory-therapy.com/public-health/smoking/semaglutide-might-beneficial-smoking-cessation/

Semaglutide Might Be Beneficial for Smoking Cessation

New use of semaglutide was associated with a lower risk for medical care related to tobacco use disorder in smokers with type 2 diabetes.

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07059377

NCT07059377 | Semaglutide for Smoking Cessation in ...

Beyond their primary focus, emerging evidence shows improved clinical outcomes such as Major Adverse Cardiovascular Events (MACE) and Obstructive Sleep Apnea ( ...

7.

uspharmacist.com

uspharmacist.com/article/semaglutide-associated-with-reduced-tobacco-use-disorder-risk

Semaglutide Associated With Reduced Tobacco Use ...

The results indicated that semaglutide was associated with a significantly lower risk for medical encounters for TUD diagnosis compared with ...

8.

clinicaltrial.be

clinicaltrial.be/en/details/23469?per_page=100&only_recruiting=0&only_eligible=0

Effects of Semaglutide on Nicotine Intake

This is an experimental investigation to examine the effects of an approved GLP-1 receptor agonist on nicotine intake and reinstatement.