Nicotine Replacement Therapy for Smoking Cessation

(CAN-DOSE Trial)

Overseen By Rachel Christian

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Medical University of South Carolina

Must be taking: Nicotine replacement

Must not be taking: Smoking cessation

Disqualifiers: Pregnancy, Cardiac arrhythmia, Angina, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

46 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you do not use other nicotine-containing products or smoking cessation medications while participating.

What data supports the effectiveness of this treatment for smoking cessation?

Research shows that using a combination of nicotine patches and lozenges can help people quit smoking, even those who smoke a lot or are highly dependent on nicotine. This combination therapy has been found to significantly increase the chances of quitting compared to using a placebo. ^{1 2 3 4 5}

Is nicotine replacement therapy safe for humans?

Nicotine replacement therapy, including high-dose nicotine patches, is generally safe and well-tolerated in humans, though some people may experience side effects like nausea, especially at higher doses. ^{6 7 8 9 10}

How does the Augmented Nicotine patch and lozenge dose treatment for smoking cessation differ from other treatments?

The Augmented Nicotine patch and lozenge dose treatment is unique because it combines higher doses of nicotine patches and lozenges, which may be more effective for very heavy and highly dependent smokers compared to standard doses. This approach aims to provide a more tailored nicotine replacement therapy (NRT) that can better address individual needs for quitting smoking. ^{5 7 11 12 13}

What is the purpose of this trial?

This trial tests if nicotine patches and lozenges can help people who both smoke and vape to quit. It compares different doses to see which works best. The goal is to find an effective way to help dual users stop using tobacco products. Nicotine patches and lozenges have been studied extensively as aids to help people stop smoking, with various studies indicating their potential effectiveness.

Research Team

Amanda Palmer

Principal Investigator

Medical University of South Carolina

Eligibility Criteria

The CAN-DOSE study is for adults over 18 who use nicotine e-cigarettes daily and smoke cigarettes weekly, wanting to quit both within a month. They must be willing to use nicotine replacement therapy (NRT) and have no medical conditions that make NRT unsafe, like recent heart issues or pregnancy.

Inclusion Criteria

E-cigarette use 5+ times/day

Mailing address in SC.

Willingness to use NRT

Exclusion Criteria

I do not have heart issues, uncontrolled vascular disease, or conditions affected by phenylalanine.

Individuals reporting current use of other nicotine-containing products and/or smoking cessation medications

Those who vape non-nicotine substances

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive varying doses of nicotine replacement therapy to aid in quitting smoking and vaping

8 weeks

Daily diary assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Augmented Nicotine patch and lozenge dose
• Regular Nicotine patch and lozenge dose

Trial Overview This study tests whether using nicotine patches and lozenges can help people stop smoking and vaping. It compares the effectiveness of regular versus higher doses of these medications in aiding cessation.

Participant Groups

Group I: Arm A Active Control 1 Intervention

21mg patch, qd + 4mg lozenge prn \[minimum of 5 \& up to 20 per day\]

Group II: Arm B Active Control 1 Intervention

21mg patch + 14mg patch qd + 4mg lozenge prn minimum of 5 \& \[up to 30 per day\]

Group III: Arm C Active Control 1 Intervention

2 x 21mg patches qd + 4mg lozenges prn \[minimum of 5 \& up to 40 per day\]

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

American Cancer Society, Inc.

Collaborator

Trials

237

Recruited

110,000+

Findings from Research

Participants receiving an 8-week nicotine replacement therapy (NRT) had significantly higher quit rates (42.5%) compared to those receiving a 4-week NRT (33.3%), indicating that longer NRT duration enhances cessation success.

Among participants in a multiple-call program, those who received both 4-week NRT shipments had a quit rate of 51.1%, compared to 31.1% for those who only received one shipment, suggesting that consistent support and extended NRT can improve outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a Temporary NRT Enhancement in a State Quitline and Web-Based Program. Cole, S., Suter, C., Nash, C., et al.[2019]

In a study of 33,690 smokers using nicotine replacement therapy (NRT) through the New York State Smokers' Quitline, about 25% reported adverse effects at 2 weeks, which increased to 42% at 3 months, but most effects were mild.

Only a small percentage (4.4%-5.4%) discontinued NRT due to these adverse effects, indicating that NRT is generally safe for users when proper screening is conducted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse effects with use of nicotine replacement therapy among quitline clients. Ossip, DJ., Abrams, SM., Mahoney, MC., et al.[2015]

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]

In a study of 400 smokers, using a nicotine inhaler combined with a nicotine patch led to significantly higher smoking cessation rates compared to using the inhaler with a placebo patch, with 60.5% abstinence at 6 weeks versus 47.5%.

The combination therapy not only improved cessation rates but also showed a trend toward better lung function and reduced respiratory symptoms in those who quit smoking, indicating its potential benefits for overall respiratory health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nicotine inhaler and nicotine patch as a combination therapy for smoking cessation: a randomized, double-blind, placebo-controlled trial. Bohadana, A., Nilsson, F., Rasmussen, T., et al.[2019]

In a study of 84,667 patients in a smoking cessation program, it was found that the prescribed doses of nicotine replacement therapy (NRT) did not increase adequately with the number of cigarettes smoked per day, leading to potential under-treatment.

Patients who received initial NRT doses below 2 mg per cigarette per day had poorer cessation outcomes, suggesting that higher doses may be necessary for heavy smokers to improve their chances of quitting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adequacy of nicotine replacement and success quitting tobacco in clinical populations: An observational study. Veldhuizen, S., Behal, A., Zawertailo, L., et al.[2023]

Nicotinell lozenges, particularly the 1 mg formulation, have been shown to be bioequivalent to 2 mg nicotine gum, providing effective nicotine delivery for smoking cessation, with significant short-term efficacy demonstrated in over 900 smokers.

The lozenges have an excellent safety profile, with only mild and reversible adverse events reported, making them a safe option for smokers seeking to quit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics, safety and efficacy from randomized controlled trials of 1 and 2 mg nicotine bitartrate lozenges (Nicotinell). Dautzenberg, B., Nides, M., Kienzler, JL., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Personalized dosing of nicotine replacement therapy versus standard dosing for the treatment of individuals with tobacco dependence: study protocol for a randomized placebo-controlled trial. [2021]

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

Clinical strategies to enhance the efficacy of nicotine replacement therapy for smoking cessation: a review of the literature. [2021]

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

Impact of a Temporary NRT Enhancement in a State Quitline and Web-Based Program. [2019]

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

Adjustment of nicotine replacement therapies according to saliva cotinine concentration: the ADONIS* trial-a randomized study in smokers with medical comorbidities. [2019]

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

The effectiveness of nicotine patch and nicotine lozenge in very heavy smokers. [2015]

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

Adverse effects with use of nicotine replacement therapy among quitline clients. [2015]

7. Germany pubmed.ncbi.nlm.nih.gov

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

8. England pubmed.ncbi.nlm.nih.gov

Effect of high-dose nicotine patch therapy on tobacco withdrawal symptoms among smokeless tobacco users. [2022]

9. Ireland pubmed.ncbi.nlm.nih.gov

Nicotine percentage replacement among smokeless tobacco users with nicotine patch. [2018]

10. England pubmed.ncbi.nlm.nih.gov

A randomized, double-blind, placebo-controlled clinical evaluation of a nicotine sublingual tablet in smoking cessation. [2015]

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

Nicotine inhaler and nicotine patch as a combination therapy for smoking cessation: a randomized, double-blind, placebo-controlled trial. [2019]

12. Ireland pubmed.ncbi.nlm.nih.gov

Adequacy of nicotine replacement and success quitting tobacco in clinical populations: An observational study. [2023]

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

Pharmacokinetics, safety and efficacy from randomized controlled trials of 1 and 2 mg nicotine bitartrate lozenges (Nicotinell). [2023]