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

NCT06088862 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2025-03-30

No results posted yet for this study

Summary

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).

Conditions

  • Smoking Cessation
  • Harm Reduction

Interventions

DRUG

Nicoderm

21mg nicotine patch daily; maximum usage 9 weeks

DRUG

Nicorette 4Mg Chewing Gum

4mg Nicorette gum (flavors - cinnamon surge, fruit chill, and mint); as needed maximum usage 9 weeks

DRUG

Nicorette Lozenge Product

4mg Nicorette mint lozenge; as needed maximum usage 9 weeks

OTHER

BIDI e-cigarette

BIDI e-cigarette (flavors - Classic, Arctic, and Solar); as needed for maximum of 5 weeks

OTHER

on!

4mg on! Nicotine Pouch (flavors - Berry, Mint, and Original); as needed for maximum usage 5 weeks

Sponsors & Collaborators

  • Foundation for a Smoke Free World INC

    collaborator OTHER

  • Rose Research Center, LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-12-27
Primary Completion
2024-04-30
Completion
2024-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06088862 on ClinicalTrials.gov