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NCT06088862 · ClinicalTrials.gov registry record · Phase 3
Evaluate Harm Reduction Products as a Second Line Intervention for Adult Smokers Who Do Not Quit With NRT
A Phase 3 study, sponsored by Rose Research Center.
- Terminated
- Registry status
- Phase 3
- Development phase
- 4
- Enrollment target
NCT06088862: Clinical Trial Phase 3 study, sponsored by Rose Research Center.
NCT06088862 is a Phase 3 study that was terminated before completion, run by Rose Research Center. The registered enrollment target is 4 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06088862, a Phase 3 study, was terminated before completion, sponsored by Rose Research Center.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 4 participants
- Enrollment target
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).
Primary Outcome
Change in expired air CO at week 10 compared to baseline
Interventions
- DRUG Nicoderm
- DRUG Nicorette 4Mg Chewing Gum
- DRUG Nicorette Lozenge Product
- OTHER on!
- OTHER BIDI e-cigarette
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2023-12-27 |
| Est. Completion | 2024-04-30 |
| Phase | Phase 3 |
Why NCT06088862 stopped before completion
NCT06088862 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 5 interventions - of which Nicoderm is the first listed.
NCT06088862 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06088862 about?
NCT06088862 is a clinical study titled "Evaluate Harm Reduction Products as a Second Line Intervention for Adult Smokers Who Do Not Quit With NRT". 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...
What is the current status of trial NCT06088862?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 4 participants. The study started on 2023-12-27. Estimated completion is 2024-04-30.
What interventions are being tested in trial NCT06088862?
The interventions under investigation include: Nicoderm (DRUG), Nicorette 4Mg Chewing Gum (DRUG), Nicorette Lozenge Product (DRUG), on! (OTHER), BIDI e-cigarette (OTHER).
Who is sponsoring clinical trial NCT06088862?
This trial is sponsored by Rose Research Center, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06088862's enrollment target sits among peer trials
4 1998th of 2000 higher than 2 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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