Semaglutide for Nicotine Addiction

Overseen By Margret Powell

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of North Carolina, Chapel Hill

Must not be taking: Nicotine replacement, Insulin, Weight control

Disqualifiers: Severe mental illness, Diabetes, 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)

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 9 weeks

24 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you have not used certain medications like nicotine replacement therapies, semaglutide, or other GLP-1 agonists in the past 30 days. If you are currently using medications that may interact with semaglutide, you may need to stop taking them to participate.

What data supports the effectiveness of the drug semaglutide for nicotine addiction?

While there is no direct evidence for semaglutide's effectiveness in treating nicotine addiction, studies have shown that semaglutide, a drug used for type 2 diabetes and weight loss, can reduce alcohol consumption in both humans and animals. This suggests it might influence addictive behaviors, which could be relevant for nicotine addiction. ^{1 2 3 4 5}

Is semaglutide safe for humans?

Semaglutide has been shown to be generally safe in humans, with studies primarily focusing on its use for type 2 diabetes and weight loss. Some people may experience gastrointestinal issues (like stomach upset) as side effects, but it has been tested in thousands of patients and is considered safe for its approved uses. ^{1 2 3 4 6}

How does the drug semaglutide differ from other treatments for nicotine addiction?

Semaglutide is unique because it is a GLP-1 receptor agonist, originally used for type 2 diabetes, and it may help with nicotine addiction by affecting the brain's reward system, similar to its effects on alcohol use. Unlike traditional nicotine replacement therapies, semaglutide is administered as a once-weekly injection, which could offer a novel approach to managing addiction. ^{1 3 5 6 7}

Research Team

Christian Hendershot, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Eligibility Criteria

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.

Inclusion Criteria

Willingness to take study medication and complete study procedures

I am between 21 and 65 years old.

Willingness to complete lab sessions involving cigarette smoking

Exclusion Criteria

I have used vaping products, cigars, chewing tobacco, or snuff at least once a week in the last month.

I have had diabetic ketoacidosis in the past.

I have diabetes or my HbA1c level was over 6.5% at screening.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive semaglutide or placebo via subcutaneous injections over 9 weeks

9 weeks

Weekly visits for injections

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Treatment Details

Interventions

• Semaglutide

Trial Overview 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.

Participant Groups

Group I: Semaglutide Experimental Treatment 1 Intervention

Participants will receive semaglutide via subcutaneous injections at escalating doses (0.25mg to 1.0mg) over 9 weeks.

Group II: Sham/Placebo Placebo Group 1 Intervention

Participants will receive sham subcutaneous injections over 9 weeks.

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Findings from Research

Semaglutide (Ozempic®) is a new subcutaneous treatment for type 2 diabetes that effectively lowers blood glucose levels by stimulating insulin release and also helps reduce body weight.

The once-weekly injection has been approved in the US, Puerto Rico, and Canada, and is also under review in other countries, with ongoing clinical development for additional conditions like obesity and liver diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Semaglutide: First Global Approval. Dhillon, S.[2019]

Subcutaneous semaglutide, a glucagon-like peptide-1 receptor agonist, has been shown to provide superior and sustained glycemic control and weight loss in over 8000 patients with type 2 diabetes, as demonstrated in the SUSTAIN clinical trial program.

In the SUSTAIN 6 trial, semaglutide significantly reduced the risk of cardiovascular events in patients at high risk, indicating its cardiovascular safety and efficacy compared to placebo and standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative efficacy, safety, and cardiovascular outcomes with once-weekly subcutaneous semaglutide in the treatment of type 2 diabetes: Insights from the SUSTAIN 1-7 trials. Aroda, VR., Ahmann, A., Cariou, B., et al.[2020]

Semaglutide (Ozempic®) is an effective once-weekly treatment for type 2 diabetes, showing superior glucose-lowering effects and greater weight loss compared to other GLP-1 receptor agonists in Phase III clinical trials.

It is approved for use in Belgium for patients with type 2 diabetes who have not achieved adequate control with other antidiabetic therapies, particularly in those with a body mass index of 30 kg/m² or higher.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Semaglutide, once weekly GLP-1 receptor agonist (Ozempic®)]. Scheen, AJ.[2019]

In a case series of 6 patients with alcohol use disorder (AUD) treated with semaglutide for weight loss, all patients showed significant improvement in AUD symptoms, with an average reduction of 9.5 points on the AUDIT scale (P < 0.001).

These findings suggest that glucagon-like peptide-1 receptor agonists (GLP-1RAs) like semaglutide may be a promising new treatment option for AUD, although further randomized clinical trials are necessary to confirm these results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Significant Decrease in Alcohol Use Disorder Symptoms Secondary to Semaglutide Therapy for Weight Loss: A Case Series. Richards, JR., Dorand, MF., Royal, K., et al.[2023]

Semaglutide, a GLP-1 analogue, significantly reduced binge-like alcohol drinking in both male and female mice and rats, indicating its potential efficacy in treating alcohol use disorder (AUD).

The study also found that semaglutide enhanced GABA release in certain brain regions of alcohol-naive rats, suggesting a mechanism of action that could help regulate alcohol consumption, although it did not affect GABA transmission in alcohol-dependent rats.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The glucagon-like peptide-1 (GLP-1) analogue semaglutide reduces alcohol drinking and modulates central GABA neurotransmission. Chuong, V., Farokhnia, M., Khom, S., et al.[2023]

Semaglutide, a GLP-1 receptor agonist for type 2 diabetes, has a good safety profile but is associated with a high prevalence of gastrointestinal disorders, reported in over 3500 cases (53.2%).

Compared to other diabetes medications like sitagliptin and empagliflozin, semaglutide has a significantly higher number of reported gastrointestinal adverse events, indicating the need for careful monitoring in certain patient subgroups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gastrointestinal disorders potentially associated with Semaglutide: an analysis from the Eudravigilance Database. Cabral Lopes, A., Roque, F., Lourenço, O., et al.[2023]

In a meta-analysis of 23 randomized trials involving 22,096 patients with type 2 diabetes, semaglutide was not found to significantly increase the overall risk of diabetic retinopathy (DR) compared to control groups.

However, the analysis indicated that semaglutide was associated with a higher risk of DR in specific subgroups, particularly in patients aged 60 years or older and those with a diabetes duration of 10 years or more, suggesting that caution is warranted in these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Semaglutide and Diabetic Retinopathy Risk in Patients with Type 2 Diabetes Mellitus: A Meta-Analysis of Randomized Controlled Trials. Wang, F., Mao, Y., Wang, H., et al.[2022]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Semaglutide: First Global Approval. [2019]

2. France pubmed.ncbi.nlm.nih.gov

Comparative efficacy, safety, and cardiovascular outcomes with once-weekly subcutaneous semaglutide in the treatment of type 2 diabetes: Insights from the SUSTAIN 1-7 trials. [2020]

3. Belgium pubmed.ncbi.nlm.nih.gov

[Semaglutide, once weekly GLP-1 receptor agonist (Ozempic®)]. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Significant Decrease in Alcohol Use Disorder Symptoms Secondary to Semaglutide Therapy for Weight Loss: A Case Series. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

The glucagon-like peptide-1 (GLP-1) analogue semaglutide reduces alcohol drinking and modulates central GABA neurotransmission. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Gastrointestinal disorders potentially associated with Semaglutide: an analysis from the Eudravigilance Database. [2023]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Semaglutide and Diabetic Retinopathy Risk in Patients with Type 2 Diabetes Mellitus: A Meta-Analysis of Randomized Controlled Trials. [2022]