Harm Reduction Products for Smoking Cessation

No longer recruiting at 1 trial location

Overseen By Perry Willette, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Rose Research Center, LLC

Must be taking: Nicotine replacement

Must not be taking: Psychoactive medications

Disqualifiers: Heart disease, Pregnancy, Smokeless tobacco, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to help people quit smoking by testing products that might reduce smoke exposure. Participants will begin with a choice of nicotine replacement therapies (NRT) such as gum, lozenges, or patches for four weeks. If someone cannot quit smoking with these, they will be randomly assigned to try a new product like a nicotine pouch or an electronic cigarette (such as the BIDI e-cigarette), or continue with NRT. This trial suits individuals who have smoked at least 10 cigarettes a day for the past year and are interested in trying new methods to quit. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the development of potentially groundbreaking smoking cessation treatments.

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

Yes, you must stop taking psychoactive medications and any nicotine replacement therapy or smoking cessation treatments within 14 days of screening to join the trial.

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

Past studies have shown that nicotine replacement therapies (NRT) like Nicoderm patches, Nicorette gum, and lozenges help people quit smoking by reducing cravings and withdrawal symptoms. These products are usually well-tolerated, though they can cause side effects such as skin irritation from patches or mouth irritation from gum and lozenges. Following the instructions is important to minimize these effects.

Research shows that electronic nicotine delivery systems (ENDS) can help people smoke fewer cigarettes. They provide a similar experience to regular cigarettes, but opinions differ on their long-term safety. Some studies suggest they may not always lead to complete smoking cessation.

Nicotine pouches, placed under the lip, do not contain tobacco and are used to reduce smoking. They pose much lower health risks compared to traditional cigarettes, but they have not shown a significant decrease in tobacco-related harm.

Overall, these treatments have been used in various studies and are generally considered safe when used as directed. It's important to understand that while they may help reduce smoking, individual experiences and side effects can vary. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about this trial because it explores personalized approaches to smoking cessation. Unlike the standard nicotine replacement therapies (NRT) like patches, gum, or lozenges, this trial considers individual preferences and responses to treatment. For those who struggle to quit with traditional NRT, the study offers alternatives like nicotine pouches and electronic nicotine delivery systems (ENDS), aiming to find what works best for each person. By tailoring treatments to individual needs, this trial could pave the way for more effective, personalized smoking cessation strategies.

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

Research has shown that nicotine replacement therapy (NRT) products like patches, gum, and lozenges can help people quit smoking. Studies have found that these products significantly increase the chances of quitting, especially for heavy smokers. In this trial, participants who respond well to NRT will either continue with their current NRT or switch to another NRT option.

For those who do not respond to NRT, the trial offers alternative approaches. Participants who prefer nicotine pouches will be randomized to either switch to nicotine pouches or remain on NRT. Although nicotine pouches are not proven to work on their own, about 41% of users reported successfully quitting smoking with these pouches.

Similarly, participants who prefer electronic nicotine delivery systems (ENDS), such as e-cigarettes, will be randomized to either switch to ENDS or remain on NRT. ENDS have helped reduce cigarette use by imitating the feel of regular cigarettes.

Overall, these alternative products might offer a better chance for those who haven't succeeded with traditional NRT. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

Adult smokers aged 22-65 who haven't quit smoking with NRT can join this trial. They must smoke at least 10 cigarettes daily for the past year, want to try e-cigarettes or nicotine pouches, and be able to use a smartphone for surveys. Pregnant women, recent participants in other trials, those planning to use unapproved cessation products, or with certain health conditions cannot participate.

Inclusion Criteria

Has signed the Informed Consent From (ICF) and is able to read and understand the information provided in the ICF.

Owns a smart phone with text message and data capabilities compatible with necessary surveys.

I am between 22 and 65 years old.

Exclusion Criteria

I use tobacco products like chewing tobacco, cigars, or hookahs monthly.

I am sexually active, can bear children, and agree to use effective birth control during the trial.

I plan to use an FDA-approved product to quit smoking, not provided by this study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment

Participants receive four weeks of NRT of their choice (gum, lozenge, or nicotine patch) and are assessed for quit-smoking status

4 weeks

Second Line Intervention

NRT non-responders are randomly assigned to either a nicotine pouch, ENDS, or remain on NRT for the next five weeks

5 weeks

Follow-up

Participants are monitored for changes in smoke exposure and smoking abstinence rates

1 week

What Are the Treatments Tested in This Trial?

Interventions

• BIDI e-cigarette
• Nicoderm
• Nicorette 4Mg Chewing Gum
• Nicorette Lozenge Product
• on!

Trial Overview The study tests if alternative harm reduction products like BIDI e-cigarettes and on! nicotine pouches help smokers quit after failing with Nicoderm patches or Nicorette gum/lozenges. Initially offered NRTs for four weeks, non-quitters are then randomly assigned to new products or continue NRT as control.

How Is the Trial Designed?

Group I: Group IIb NRT Non-Responder - Pouch Preferrers Control Experimental Treatment 3 Interventions

Participants that were unsuccessful in quitting smoking using NRT in the first four weeks and reported a preference to try a nicotine pouch. Randomized to be remain on NRT for the next five weeks.

Group II: Group IIa NRT Non-Responder - Pouch Preferrers Experimental Treatment 4 Interventions

Participants that were unsuccessful in quitting smoking using NRT in the first four weeks and reported a preference to try a nicotine pouch. Randomized to be switched to nicotine pouch for the next five weeks.

Group III: Group IIIb NRT Non-Responder - ENDS Preferrers Control Experimental Treatment 3 Interventions

Participants that were unsuccessful in quitting smoking using NRT in the first four weeks and reported a preference to try ENDS. Randomized to be remain on NRT for the next five weeks.

Group IV: Group IIIa NRT Non-Responder - ENDS Preferrers Experimental Treatment 4 Interventions

Participants that were unsuccessful in quitting smoking using NRT in the first four weeks and reported a preference to try ENDS. Randomized to be switched to ENDS for the next five weeks.

Group V: Group I - NRT Responder Experimental Treatment 3 Interventions

Participants that were successful in quitting smoking using NRT in the first four weeks of the study will have the option of remaining on their current NRT or switching to one of the other two options for the next five weeks.

Nicoderm is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Nicoderm for:

• Smoking cessation

Approved in European Union as Nicotinell for:

• Smoking cessation

Approved in Canada as Nicoderm for:

• Smoking cessation

Approved in Japan as Nicotrol for:

• Smoking cessation

Who Is Running the Clinical Trial?

Rose Research Center, LLC

Lead Sponsor

Trials

17

Recruited

1,600+

Foundation for a Smoke Free World INC

Collaborator

Trials

15

Recruited

2,100+

Citations

1. harmreductionjournal.biomedcentral.com harmreductionjournal.biomedcentral.com/articles/10.1186/s12954-024-01064-0

Smoking reduction using an electronic nicotine delivery ... In this study, the ENDS effectively replicated the subjective rewarding effects of participants' usual brands of cigarettes and led to a substantial reduction ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9160848/

A randomised, crossover, clinical study to assess nicotine ... BIDI Stick ENDS delivered nicotine to users comparably to their UB combustible cigarette and higher than JUUL ENDS, and also elicited similar subjective ...

3. nature.com nature.com/articles/s41598-025-97491-5

Disposable e-cigarettes and their nicotine delivery, usage ... The results showed that the disposable e-cigarette was as effective in nicotine delivery as the cigarette and more effective than the pod e ...

4. qeios.com qeios.com/read/X3KDA8

A Randomised, Crossover, Clinical Study to Assess ... BIDI Stick ENDS delivered nicotine to users comparably to their UB cigarette and also elicited similar subjective effects such as satisfaction and relief.

5. researchgate.net researchgate.net/publication/382653659_Smoking_reduction_using_an_electronic_nicotine_delivery_system_ENDS_with_nicotine_delivery_similar_to_combustible_cigarettes

(PDF) Smoking reduction using an electronic nicotine ... Results Over 12 weeks, ENDS use increased to an average of 15.8 occasions per day (SD = 20.2) and self-reported cigarette consumption decreased ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39075535/

Smoking reduction using an electronic nicotine delivery ... ENDS use increased, and cigarette consumption decreased by 82% (from 16.7 to 3.0 cigarettes/day) and eCO decreased by 27% in 12 weeks. ENDS ...

7. harmreductionjournal.biomedcentral.com harmreductionjournal.biomedcentral.com/articles/10.1186/s12954-022-00638-0

A randomised, crossover, clinical study to assess nicotine ... In this study, we assessed nicotine pharmacokinetics and subjective effects of 6 flavour variants of BIDI Stick ENDS in adult smokers, compared to cigarettes ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2352853219301683

E-cigarette and hookah adoption patterns: Is the harm ... However, other studies have found that smokers are less likely to quit when using ENDS (Grana, Benowitz, & Glantz, 2014). Hence, ENDS ads' claims for their ...