Comprehensive Tobacco Treatment for Smoking Cessation

Overseen By Steven Sutton, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Must not be taking: Smoking cessation medications

Disqualifiers: Pregnant, Breastfeeding, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 10 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness and cost-efficiency of a smartphone-based program in helping people quit smoking. Participants will either receive standard treatment with nicotine patches and lozenges, along with support from the Florida Quitline, or use an automated system featuring videos and texts tailored to their smoking habits and stress levels. The trial seeks individuals who smoke more than five cigarettes a day and have a smartphone compatible with the study app. For those who meet these criteria, joining this trial might be a good opportunity to quit smoking. As an unphased trial, this study offers a unique chance to explore innovative methods for quitting smoking, potentially benefiting health and well-being.

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

If you are currently using smoking cessation medications, you cannot join the trial. The protocol does not specify about other medications, so it's best to discuss with the trial team.

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

A previous study found the Nicorette Lozenge to be well tolerated over 52 weeks, meaning most participants did not experience serious side effects. However, due to nicotine's addictive nature, careful use is advised. Research has shown that the nicotine patch can cause skin irritation for some, but it is generally considered safe for adults attempting to quit smoking.

Research on the smartphone-based treatment is ongoing. This method uses videos and messages on phones to aid smoking cessation. While there is limited information on its safety, it aims to help users manage cravings and stress.

Overall, these treatments are designed to ease the physical and mental effects of quitting nicotine. It is important to follow instructions and consult a healthcare provider with any concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for smoking cessation because they incorporate innovative technology alongside traditional methods. Unlike standard nicotine replacement therapies, such as patches and lozenges, the Automated Treatment arm adds a digital component with 12 tailored videos and on-demand content delivered via smartphones. This approach not only provides ongoing support and motivation but also allows for personalized treatment based on individual smoking behaviors and stress levels. By combining technology with pharmacological aids, this method aims to enhance engagement and potentially improve quit rates among smokers.

What evidence suggests that this trial's treatments could be effective for smoking cessation?

In this trial, participants will be randomized into different treatment arms to evaluate smoking cessation methods. Previous studies have shown that people using nicotine lozenges had better success when they used more lozenges, with these positive effects lasting for a whole year. For nicotine patches, research found that users were more than twice as likely to quit smoking compared to those using a placebo patch. One study showed a 70.59% quit rate at 26 weeks when combined with support like counseling. Research also indicates that smartphone apps can aid smokers in quitting. Studies suggest that people using these apps have a better chance of quitting than those who don't. Each of these methods has proven effective on its own, and combining them in this trial could potentially improve overall success rates. ^{6 7 8 9 10}

Who Is on the Research Team?

Damon J Vidrine, Dr.PH

Principal Investigator

Moffitt Cancer Center

Jennifer Vidrine, PhD, MS

Principal Investigator

Moffitt Cancer Center

Are You a Good Fit for This Trial?

This trial is for English or Spanish speakers who currently smoke more than 5 cigarettes a day, are willing to try quitting within a week of joining, have smoked over 100 cigarettes in their lifetime, own a smartphone compatible with the study's app and have an email address. Pregnant or breastfeeding individuals, those on smoking cessation meds, enrolled in another cessation study or living with someone in this study can't join.

Inclusion Criteria

>100 lifetime cigarettes

I have a working email address.

Process a smartphone compatible with the project app

Exclusion Criteria

Enrolled in a smoking cessation study

Household member enrolled in the study

Failure to electronically confirm participation with 14 days of randomization via electronic link sent to participant's smartphone

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 10-week supply of nicotine patches and lozenges, with weekly smartphone assessments

10 weeks

Weekly electronic assessments

Follow-up

Participants are monitored for smoking abstinence and other outcomes

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Counceling
• Nicotine lozenge
• Nicotine patch
• Smartphone-delivered automated treatment

Trial Overview The trial is testing how well and cost-effectively a smartphone app helps people quit smoking compared to other methods. Participants will receive automated treatment through the app along with nicotine patches or lozenges and counseling support.

How Is the Trial Designed?

Group I: Automated Treatment Experimental Treatment 3 Interventions

Participants randomized to Automated Treatment (AT) will be given a 10-week supply of nicotine patches and lozenges. AT will also comprise of: 1) 12 proactive treatment videos, delivered weekly, that are tailored on smoking status, motivation, agency, and/or negative affect/stress; 2) 26 weeks of on-demand access to treatment content; 3) 26 weeks of text content

Group II: Standard Treatment Active Control 3 Interventions

Participants randomized to Standard Treatment (ST) will be provided with a 10-week supply of nicotine patches and lozenges. ST participants will be connected with Florida Quitline services and will complete weekly 4-item smartphone assessments electronically for 26 weeks. The weekly assessments consist of questions on smoking status, motivation, self-efficacy, and perceived stress.

Nicotine lozenge is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Nicorette Lozenge for:

• Smoking cessation

Approved in Canada as Nicotrol Lozenge for:

• Smoking cessation

Approved in European Union as Nicorette Lozenge for:

• Smoking cessation

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3174063/

A Comparison of the Nicotine Lozenge and Nicotine Gum ... At 8 weeks, successful quitters in the lozenge group gained 3.0 ± 6.3 lbs compared to the gum group which gained 8.4 ± 9.2 lbs with t= −2.4, p= 0.02, but this ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2834192/

Nicotine Patch vs. Nicotine Lozenge for Smoking Cessation However, only 20-25% of smokers who use transdermal nicotine or nicotine lozenges report abstinence 6-months after a quit date (Shiffman et al., 2002a; Stead et ...

3. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/211489

Efficacy of a Nicotine Lozenge for Smoking Cessation Significant treatment effects were maintained for a full year. Smokers who used more lozenges achieved significantly better treatment effects.

4. tobaccopreventioncessation.com tobaccopreventioncessation.com/The-effectiveness-of-nicotine-replacement-therapy-on-oral-smokeless-tobacco-cessation,208023,0,2.html

The effectiveness of nicotine replacement therapy on oral ... Several studies have been conducted to test the effectiveness of NRTs, with mixed results. A previous systematic review found that nicotine patches or gum did ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0740547204001278

The effectiveness of nicotine patch and nicotine lozenge in ... The results consistently showed that currently approved doses of NRT significantly improved quit rates in very heavy and highly dependent smokers. Both a 21-mg ...

6. haleonhealthpartner.com haleonhealthpartner.com/en-us/respiratory-health/brands/nicotine-replacement-therapy/nicorette-lozenges/safety-information/

Nicorette Lozenges Safety Information The Nicorette Lozenge was found to be well tolerated. 1 Safety was evaluated in a randomized, double-blind, placebo-controlled clinical trial over 52 weeks.

7. nicorette.ca nicorette.ca/products/lozenge

NICORETTE® Smoking Cessation Lozenge Only to be used by adults who are trying to quit smoking. WARNING: This product contains nicotine. Nicotine is highly addictive. Flavours available. Mint.

8. medsafe.govt.nz medsafe.govt.nz/profs/datasheet/n/nicorettecooldrops.pdf

Data Sheet NICORETTE® Cooldrops Lozenges 2 mg are suitable for smokers with a low nicotine dependency e.g. those smoking their first cigarette of the day more.

9. reference.medscape.com reference.medscape.com/drug/nicorette-lozenge-nicotine-lozenge-999318

nicotine lozenge (OTC) Smoking Cessation. Weeks 1-6: 1 lozenge q1-2hr. Weeks 7-9: 1 lozenge q2-4hr. Weeks 10-12: 1 lozenge q4-8hr. Do not exceed >5 lozenges/6hr.

10. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2018/021330Orig1s021.pdf

APPLICATION NUMBER: NDA 21-330/S-21 Nicorette Lozenges to calm your cravings for nicotine and help you stay smoke free. Prior to the quit date, get rid of all your cigarettes ...