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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 is a Phase 3 study that was terminated before completion, run by Rose Research Center. The registered enrollment target is 4 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06088862
The ClinicalTrials.gov registry entry for NCT06088862 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rose Research Center, which has 11 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Nicoderm is the first listed.
NCT06088862 reports 0 study locations.
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.
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