SREC + Nicotine Lozenge for Smoking Cessation

Overseen By Hanna Vanderloo, RN, MSN

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Masonic Cancer Center, University of Minnesota

Must not be taking: Anti-inflammatories, Metabolic enzyme-affecting

Disqualifiers: Nicotine products, Immune disorders, Respiratory diseases, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

125 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is focused on characterizing the toxic and carcinogenic potential of the Standardized Research E-cigarette (SREC) developed by the National Institute on Drug Abuse. In the environment of continuously changing e-cigarette market, SREC was developed as a model e-cigarette that will remain available for an extended period of time and can be used as a bridging element in various studies aimed at evaluating the value and limitations of e-cigarettes as tobacco risk reduction tools. Our overall goal is to generate initial reference data on chemical exposures and associated effects in smokers switching to SREC.

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

The trial requires that you do not take anti-inflammatory medications or any medications that affect relevant metabolic enzymes. If you are on such medications, you may need to stop them to participate.

What data supports the idea that SREC + Nicotine Lozenge for Smoking Cessation is an effective treatment?

The available research shows that using electronic nicotine delivery systems (ENDS), like the Standardized Research E-cigarette (SREC), can help reduce smoking. In a study, smokers who used ENDS reduced their smoking more than those who didn't use them. Additionally, more people in the group using the higher nicotine ENDS made independent purchases, suggesting they found it helpful. While the results were not statistically significant, there were positive trends in quitting attempts and reduced smoking behavior. This suggests that SREC, when combined with nicotine lozenges, could be an effective treatment for smoking cessation. ^{1 2 3 4 5}

What safety data exists for SREC and Nicotine Lozenge in smoking cessation?

Safety data for the use of electronic cigarettes (including SREC) in smoking cessation is limited. Some studies report minor side effects such as mouth and throat irritation, headache, vertigo, and nausea. However, these findings are mainly from surveys and not from rigorous clinical trials. The efficacy and safety of e-cigarettes for smoking cessation remain poorly understood, and more formal studies are needed. There is no specific safety data available for the combination of SREC and Nicotine Lozenge. ^{6 7 8 9 10}

Is the treatment Standardized Research E-cigarette (SREC) a promising treatment for smoking cessation?

The Standardized Research E-cigarette (SREC) is a promising treatment for smoking cessation because it offers a new option for smokers trying to quit. It can be used alongside nicotine lozenges, which are known to help people stop smoking. This combination might increase the chances of successfully quitting smoking. ^{11 12 13 14 15}

Research Team

Irina Stepanov, PhD

Principal Investigator

University of Minnesota, Division of Environmental Health Sciences

Eligibility Criteria

This trial is for adult smokers aged 18-65 who smoke more than 5 cigarettes daily, have been smoking for at least a year, and haven't tried to quit in the last 3 months. Participants must be in good physical and mental health, not use other tobacco or nicotine products, and agree to switch completely to e-cigarettes or nicotine lozenges. Pregnant women or those on certain medications are excluded.

Inclusion Criteria

I am not pregnant, nursing, or planning to become pregnant.

Biochemically confirmed regular smoking status by a NicAlert test level of 6

I smoke 5 or more cigarettes daily and don't use other tobacco products.

Exclusion Criteria

Unstable living environment that would compromise the ability to attend visits, sequester study products or complete study procedures outside of visits

I have not tested positive for restricted drugs or failed the temperature test for the sample.

I use tobacco or nicotine products regularly, but not cigarettes.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants switch from smoking cigarettes to using the Standardized Research E-cigarette (SREC) or nicotine mini-lozenge

8 weeks

Regular visits for monitoring and data collection

Follow-up

Participants are monitored for safety and effectiveness after treatment, with focus on biomarkers and product use

1 year

Treatment Details

Interventions

• Nicotine Mini-Lozenge
• Standardized Research E-cigarette (SREC)

Trial Overview The study tests the toxic and carcinogenic potential of a Standardized Research E-cigarette (SREC) compared with Nicotine Mini-Lozenge. It aims to provide reference data on chemical exposures when regular smokers switch from traditional cigarettes to SRECs or medicinal nicotine.

Participant Groups

Group I: Switching from Smoking Cigarettes to SREC Experimental Treatment 1 Intervention

Group II: Switching from Smoking Cigarettes to Nicotine Mini-Lozenge Experimental Treatment 1 Intervention

Group III: Usual Brand Cigarettes Active Control 1 Intervention

Who Is Running the Clinical Trial?

Masonic Cancer Center, University of Minnesota

Lead Sponsor

Trials

285

Recruited

15,700+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Findings from Research

Participants in the study generally had positive experiences using nicotine-containing e-cigarettes for smoking cessation, finding them helpful in managing nicotine cravings, especially when compared to nicotine replacement therapy (NRT).

Despite the positive feedback, there were concerns about the potential for developing a vaping habit as a replacement for smoking addiction, highlighting the need for further research on the long-term use of e-cigarettes as a quit aid.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Participant Experiences of a Quit Smoking Attempt Through Either Nicotine Replacement Therapy (NRT) Methods or the Use of an E-cigarette. Jones, G., McIntosh, E., Brose, LS., et al.[2022]

E-cigarettes have been shown to significantly reduce the desire to smoke and the number of cigarettes smoked per day in small clinical studies, suggesting they may help modify smoking habits.

While e-cigarettes may have fewer adverse effects compared to nicotine patches and can aid in short-term smoking reduction, there is limited evidence for their long-term effectiveness in achieving sustained smoking cessation beyond 6 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of electronic cigarettes for smoking cessation. Orr, KK., Asal, NJ.[2018]

In a randomized trial involving 68 adult smokers, those using electronic nicotine delivery systems (ENDS) showed a significant reduction in cigarette smoking compared to a control group, indicating potential efficacy in smoking cessation.

Participants using the higher nicotine (24 mg) ENDS were more likely to continue using the product and make independent purchases, suggesting that higher nicotine delivery may enhance user engagement and support smoking reduction efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Naturalistic, Randomized Pilot Trial of E-Cigarettes: Uptake, Exposure, and Behavioral Effects. Carpenter, MJ., Heckman, BW., Wahlquist, AE., et al.[2018]

A systematic review of six randomized controlled trials found no significant difference in smoking cessation rates between electronic nicotine delivery systems (ENDS) and traditional nicotine replacement therapies (NRT), indicating that ENDS may not be more effective for quitting smoking.

The overall quality of evidence was rated as low or very low, highlighting the need for further research to better understand the effectiveness and safety of ENDS compared to NRT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking cessation in individuals who use vaping as compared with traditional nicotine replacement therapies: a systematic review and meta-analysis. Pound, CM., Zhang, JZ., Kodua, AT., et al.[2023]

A systematic review of 29 studies found low certainty that the flavor of electronic nicotine delivery systems (ENDS) influences the intention to quit smoking or the likelihood of making a quit attempt.

The evidence regarding the impact of nontobacco versus tobacco/unflavored ENDS on smoking cessation success is very low, indicating that more high-quality research is needed to draw definitive conclusions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of flavored electronic nicotine delivery systems in smoking cessation: A systematic review. Liber, AC., Knoll, M., Cadham, CJ., et al.[2023]

In a study involving 49 young adult e-cigarette users, compliance with using a standardized e-cigarette device and assigned e-liquid flavors significantly declined after the first week, indicating challenges in maintaining protocol adherence over time.

The correlation between nicotine intake (measured by serum cotinine levels) and e-cigarette use metrics (like puff count and duration) was strong in the first week but weakened in subsequent weeks, suggesting that simply assigning devices and flavors may not be enough to ensure consistent use in research settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compliance in Controlled E-cigarette Studies. Rebuli, ME., Liu, F., Urman, R., et al.[2021]

Smokers who switched to JUUL-brand electronic nicotine delivery systems (ENDS) for an average of 3 years showed significantly lower levels of harmful and potentially harmful constituents (HPHCs) compared to those who continued smoking cigarettes, indicating a reduction in exposure to toxic substances.

The study found that Switchers had lower markers of inflammation and respiratory symptoms, as well as reduced dependence on nicotine, suggesting that switching to JUUL may lower health risks associated with smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing Adult Smokers who Switched to JUUL vs Continuing Smokers: Biomarkers of Exposure and of Potential Harm and Respiratory Symptoms. Shiffman, S., Oliveri, DR., Goldenson, NI., et al.[2023]

E-cigarettes may help reduce cigarette consumption and could be as effective for smoking cessation as nicotine patches, based on a review of 7 studies from a larger pool of 169 publications.

There is currently no significant difference in adverse event rates between e-cigarettes and nicotine patches, but more extensive research is needed to fully understand their safety and efficacy for quitting smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic cigarettes in North America: history, use, and implications for smoking cessation. Franck, C., Budlovsky, T., Windle, SB., et al.[2018]

The study found that the ECX-Joyetech E-Vic Mini exposure equipment does not consistently produce aerosols that meet the necessary conditions for reliable preclinical studies, particularly with low subohm resistance coils.

To ensure accurate risk assessments of e-cigarettes, the equipment's performance must be improved, especially by increasing airflow for certain coils, as current results may not be trustworthy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical and chemical characterizations of a reference e-cigarette used in animal testing. Soulet, S., Constans, L., Quinty, V.[2023]

Electronic cigarettes are popular among patients as a smoking cessation aid, but they are not approved by the FDA due to concerns about manufacturing practices and the presence of carcinogens.

While some studies suggest that e-cigarettes may help users reduce or quit traditional cigarette smoking, many of these studies have biases, and more rigorous research is needed to confirm their safety and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic cigarettes: do they have a role in smoking cessation? Odum, LE., O'Dell, KA., Schepers, JS.[2022]

The prototype mini lozenge for nicotine replacement therapy (NRT) was found to be bioequivalent to a commercially available mini lozenge, showing no significant differences in key pharmacokinetic parameters such as maximum plasma nicotine concentration and overall nicotine absorption.

The most common side effect reported was mild throat irritation, with no serious adverse events, indicating that the new lozenge is a safe option for smokers seeking to manage withdrawal symptoms during their quit attempts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetic Characterization of a Prototype Mini Nicotine Lozenge. Lai, PM., Araga, M., Hamilton, A., et al.[2022]

The study found that three prototype 4-mg nicotine lozenges produced in India were bioequivalent to the globally marketed Nicorette® 4-mg lozenge, indicating they can effectively deliver similar levels of nicotine to the bloodstream.

All prototype lozenges were well tolerated and had safety profiles comparable to the reference product, suggesting they are a safe alternative for nicotine replacement therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetic characterization of three novel 4-mg nicotine lozenges . Sukhija, M., Srivastava, R., Kaushik, A.[2018]

This study involves 280 low socioeconomic status smokers to evaluate the effects of switching from high nicotine cigarettes to reduced nicotine content (RNC) cigarettes over 18 weeks, aiming to see if they can reduce smoking frequency without negative health impacts.

The primary goal is to assess whether these smokers can adhere to using only RNC cigarettes and whether this approach leads to lower nicotine dependence and reduced exposure to harmful tobacco smoke biomarkers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduced nicotine content cigarettes in smokers of low socioeconomic status: study protocol for a randomized control trial. Krebs, NM., Allen, SI., Veldheer, S., et al.[2023]

In a study of 642 smokers, transdermal nicotine showed a trend towards higher quit rates compared to nicotine lozenges, with 24.3% quitting at the end of treatment versus 18.7% for lozenges.

Smokers who preferred transdermal nicotine and did not use nicotine to manage emotional distress had better success rates, suggesting that individual preferences and reasons for smoking can influence treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nicotine patch vs. nicotine lozenge for smoking cessation: an effectiveness trial coordinated by the Community Clinical Oncology Program. Schnoll, RA., Martinez, E., Tatum, KL., et al.[2022]

In a study involving 34 healthy adult smokers, tobacco-free oral nicotine pouches (NPs) showed similar nicotine absorption to lozenges and significantly better absorption than gum, indicating they may be an effective alternative for nicotine delivery.

Participants reported higher satisfaction with NPs compared to lozenges, and NPs had a lower incidence of minor adverse events, suggesting they are a well-tolerated option for smokers seeking nicotine replacement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised study to assess the nicotine pharmacokinetics of an oral nicotine pouch and two nicotine replacement therapy products. Azzopardi, D., Ebajemito, J., McEwan, M., et al.[2022]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Participant Experiences of a Quit Smoking Attempt Through Either Nicotine Replacement Therapy (NRT) Methods or the Use of an E-cigarette. [2022]

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

Efficacy of electronic cigarettes for smoking cessation. [2018]

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

A Naturalistic, Randomized Pilot Trial of E-Cigarettes: Uptake, Exposure, and Behavioral Effects. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Smoking cessation in individuals who use vaping as compared with traditional nicotine replacement therapies: a systematic review and meta-analysis. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

The role of flavored electronic nicotine delivery systems in smoking cessation: A systematic review. [2023]

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

Compliance in Controlled E-cigarette Studies. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Comparing Adult Smokers who Switched to JUUL vs Continuing Smokers: Biomarkers of Exposure and of Potential Harm and Respiratory Symptoms. [2023]

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

Electronic cigarettes in North America: history, use, and implications for smoking cessation. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Physical and chemical characterizations of a reference e-cigarette used in animal testing. [2023]

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

Electronic cigarettes: do they have a role in smoking cessation? [2022]

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

Pharmacokinetic Characterization of a Prototype Mini Nicotine Lozenge. [2022]

12. Germany pubmed.ncbi.nlm.nih.gov

Pharmacokinetic characterization of three novel 4-mg nicotine lozenges . [2018]

13. England pubmed.ncbi.nlm.nih.gov

Reduced nicotine content cigarettes in smokers of low socioeconomic status: study protocol for a randomized control trial. [2023]

14. Ireland pubmed.ncbi.nlm.nih.gov

Nicotine patch vs. nicotine lozenge for smoking cessation: an effectiveness trial coordinated by the Community Clinical Oncology Program. [2022]

15. England pubmed.ncbi.nlm.nih.gov

A randomised study to assess the nicotine pharmacokinetics of an oral nicotine pouch and two nicotine replacement therapy products. [2022]