Harm Reduction Products for Smoking Cessation

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

4 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will determine whether a range of products along the reduced-risk continuum can reduce smoke exposure for individuals who fail to quit smoking using current medically approved nicotine replacement therapy (NRT) products. The strategy will be to offer 325 smokers four weeks of NRT of their choice (gum, lozenge, or nicotine patch) and assess them for quit-smoking status at the end of the period. Seven-day point abstinence will be used to determine responder status at the end of the four-week period (CO of \<6 ppm at both CO collection points during that seven-day period and self-report of no smoking during that seven-day period). Those who have not quit, and who therefore have a very low chance of later success (a consistent finding in prior studies and to be verified in the proposed study), will be randomly assigned to either receive a potential "rescue" product (nicotine pouch or ENDS (electronic nicotine delivery system), or remain on NRT (control group).

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+