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Nicotine Replacement Therapy

Harm Reduction Products for Smoking Cessation

Phase 3

Waitlist Available

Research Sponsored by Rose Research Center, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Is 22 to 65 years of age (inclusive) at screening.

Smokes an average of at least 10 commercially available cigarettes per day and has done so for the last 12 months.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 7 - week 10

Awards & highlights

Study Summary

This trial will test products to reduce smoke exposure for smokers who can't quit using existing NRTs. 325 smokers will try NRTs for 4 weeks & those who don't quit will get "rescue" products or stay on NRT.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects include irritation from e-cigarette vapor or nicotine pouches; possible addiction; throat/mouth discomfort; nausea; headaches; dizziness from high nicotine intake. Individual reactions may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 22 and 65 years old.

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I have been smoking at least 10 cigarettes daily for the past year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 7 - week 10

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 7 - week 10

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 7 - week 10 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in smoke exposure for NRT non-responders

Secondary outcome measures

Smoking abstinence rates for NRT non-responders

Trial Design

5Treatment groups

Experimental Treatment

Group I: Group IIb NRT Non-Responder - Pouch Preferrers ControlExperimental Treatment3 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 PreferrersExperimental Treatment4 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 ControlExperimental Treatment3 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 PreferrersExperimental Treatment4 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 ResponderExperimental Treatment3 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nicoderm

2005

N/A

~30

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Rose Research Center, LLCLead Sponsor

15 Previous Clinical Trials

1,132 Total Patients Enrolled

Foundation for a Smoke Free World INCOTHER

14 Previous Clinical Trials

1,824 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I meet the criteria for participation in this clinical investigation?

"To qualify for this trial, applicants must have previously quit smoking and be between the ages of 22 and 65. This research project is looking to enroll around 325 patients in total."

Answered by AI

Does this experiment necessitate potential participants to be of legal age?

"To be accepted into this medical trial, one must fall between the age brackets of 22 and 65. For patients younger than 18 or over 65 there are 9 and 137 respective clinical trials available for them to join."

Answered by AI

Are there opportunities to take part in this investigation currently available?

"Clinicaltrials.gov reveals that this particular medical study, which was published on November 15th 2023 and last edited on October 12th 2023 is not accepting patients at this time. However, there are an additional 151 trials actively seeking participants presently."

Answered by AI

What potential harms are associated with Group I - NRT Responders?

"Our analysts at Power have given Group I - NRT Responder a score of 3, as the Phase 3 trial has yielded positive results that demonstrate its efficacy and safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluate Harm Reduction Products as a Second Line Intervention for Adult Smokers Who Do Not Quit With NRT

2023. "Evaluate Harm Reduction Products as a Second Line Intervention for Adult Smokers Who Do Not Quit With NRT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06088862.