300 Participants NeededMy employer runs this trial

Tirzepatide for Smoking Cessation

Recruiting at 3 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Southern California
Must be taking: Nicotine patches
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a medication called tirzepatide to determine its effectiveness in helping people quit smoking and manage weight gain after quitting. Participants will use either tirzepatide or a placebo, along with nicotine patches, for 16 weeks. The trial seeks individuals who have smoked at least 10 cigarettes a day for over two years and have a body mass index (BMI) of 25 or higher. This study may suit those serious about quitting smoking soon and open to weekly clinic visits. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Do I have to stop taking my current medications for the trial?

The trial requires that you stop taking certain medications, such as other weight loss, diabetes, or smoking cessation medications (except nicotine patches) and psychiatric medications if they were started or changed in the past 30 days. If you're on opioid replacement therapy, you can continue if you provide documentation.

Is there any evidence suggesting that tirzepatide is likely to be safe for humans?

Research shows that tirzepatide, a drug tested to help people quit smoking, has also been studied for weight loss and diabetes. This research provides insight into its safety. While safety information is still being gathered, studies have reported some side effects. These may include nausea, diarrhea, and reduced appetite, but they are usually mild and temporary.

Tirzepatide belongs to a group of drugs called GLP-1 receptor agonists. These drugs are generally well-tolerated, but monitoring for any side effects is important. For those considering joining a trial, it's reassuring to know that this treatment has been used safely in other contexts. Always discuss any concerns with a doctor.12345

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

Tirzepatide is unique because it's being explored for smoking cessation, an area where traditional options like nicotine replacement therapies and medications such as varenicline and bupropion are typically used. Most treatments for smoking cessation focus on reducing nicotine cravings or blocking its effects. However, Tirzepatide, originally developed for diabetes, works by mimicking hormones that regulate appetite and blood sugar, potentially addressing smoking-related cravings differently. This novel approach could offer a fresh angle in helping people quit smoking, which has researchers intrigued about its potential effectiveness.

What evidence suggests that tirzepatide might be an effective treatment for smoking cessation?

Research has shown that tirzepatide, a medication with dual actions, might help people quit smoking by reducing nicotine cravings. This trial will compare tirzepatide to a placebo to assess its effectiveness in smoking cessation. Studies have found that medications affecting GLP-1 receptors, which play a role in hunger and cravings, can decrease both nicotine and food cravings. Tirzepatide is already known to aid in weight loss and blood sugar control, potentially helping people avoid weight gain after quitting smoking. Early evidence suggests that because tirzepatide targets two receptors instead of just one, it might be more effective than other similar treatments. However, further research is needed to fully understand its impact on smoking cessation.13678

Are You a Good Fit for This Trial?

This trial is for adults aged 21-65 who are overweight or obese (BMI of 25 or higher), smoke at least 10 cigarettes daily for over two years, want to quit smoking soon, and can attend weekly visits. Participants must be able to use nicotine patches and a cessation app, and women must use birth control.

Inclusion Criteria

6. Ability to adhere to weekly visits and study procedures over the study period (i.e., no plans to move or travel for extended periods)
7. Exhaled CO of \>5ppm at baseline
8. Use of an acceptable birth control method for female participants\*
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive subcutaneous tirzepatide or placebo over 16 weeks with weekly clinic visits

16 weeks
16 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with follow-up visits at Week 17 and Week 27

10 weeks
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Tirzepatide

Trial Overview

The study compares tirzepatide injections versus placebo shots in helping people quit smoking. All participants also get nicotine patches. The trial lasts about 16 weeks with follow-up visits up to week 27 across four U.S. sites.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: TirzepatideExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials
956
Recruited
1,609,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials
2,658
Recruited
3,409,000+

Citations

Multi-Site Trial of Tirzepatide for Smoking Cessation

This multi-site clinical trial will generate data on the efficacy of tirzepatide for smoking cessation and associated outcomes (e.g., ...

Investigating the Impact of Tirzepatide Treatment on ...

The results of this study could provide evidence of a novel treatment for individuals whose current treatment has been ineffective. Data gained from this study ...

GLP-1 receptor agonists for smoking cessation - PMC - NIH

Emerging evidence from preclinical studies and limited clinical trials suggests that GLP-1 RAs may reduce nicotine cravings and intake by ...

(PDF) Neurobehavioral Impact of Tirzepatide

Tirzepatide, a dual GIP/GLP-1 receptor agonist, has demonstrated significant efficacy in weight loss and glycemic control.

Glucagon‐like Peptide-1 Agonists and Smoking Cessation

The glucagon‐like peptide 1 (GLP-1) agonists such as semaglutide (Ozempic®, Wegovy®) and tirzepatide (Mounjaro®) have shown efficacy inducing weight loss in ...

Targeting GLP-1 receptors to reduce nicotine use disorder

Specifically, after six weeks of treatment 46.3 % of participants receiving exenatide + NRT were abstinent compared to 26.8 % of participants treated with ...

GLP-1 receptor agonists for smoking cessation: a narrative...

Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) may aid smoking cessation by reducing nicotine cravings. These agents also prevent weight ...

Real-World Safety Concerns of Tirzepatide - PMC - NIH

Despite its efficacy, real-world safety data remain limited. This study analyzed post-marketing adverse events (AEs) associated with tirzepatide ...