NCT06088862 is a Phase 3 clinical trial of Nicoderm in Smoking Cessation, sponsored by Rose Research Center, LLC.

Who is sponsoring NCT06088862?

NCT06088862 is sponsored by Rose Research Center, LLC.

What drugs are being tested in NCT06088862?

Interventions in NCT06088862: Nicoderm, Nicorette 4Mg Chewing Gum, Nicorette Lozenge Product, BIDI e-cigarette, on!.

What condition does NCT06088862 study?

NCT06088862 studies Smoking Cessation, Harm Reduction.

Is NCT06088862 still recruiting?

NCT06088862 is currently terminated. Last updated 30 March 2025.

Last reviewed 2025-03-30 · How we verify

NCT06088862

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Terminated Phase 3 Last updated 30 March 2025

What this trial tests

Phase 3 trial testing Nicoderm in Smoking Cessation in 4 participants. Terminated before completion.

Timeline

27 December 2023

Primary endpoint
30 April 2024

30 April 2024

Quick facts

Lead sponsor	Rose Research Center, LLC
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	4
Start date	27 December 2023
Primary completion	30 April 2024
Estimated completion	30 April 2024
Sites	2 locations across United States

Drugs / interventions tested

Nicoderm
Nicorette 4Mg Chewing Gum — full drug profile →
Nicorette Lozenge Product — full drug profile →
BIDI e-cigarette
on!

Conditions studied

Smoking Cessation — all drugs for Smoking Cessation →
Harm Reduction — all drugs for Harm Reduction →

Sponsor

Rose Research Center, LLC — full company profile →

Who can join

Adults 22 to 65, any sex, with Smoking Cessation or Harm Reduction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Electronic cigarettes for smoking cessation.
Lindson N, Butler AR, McRobbie H, Bullen C, et al · · 2025 · cited 32× · PMID 39878158 · DOI 10.1002/14651858.cd010216.pub9

Verify or expand the search:

Other trials of Nicoderm

Trials testing the same drug.

NCT06554873 — Adaptive Use of Nicotine Substitution to Maintain Smoking Reduction/Abstinence in Nicotine Responders · Phase 3 · completed

Other recruiting trials for Smoking Cessation

Currently open trials in the same condition.

NCT07420621 — Preliminary Effectiveness of Enhanced Text Message + Incentives · NA · recruiting
NCT07224087 — Development of a MHBC Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Patients · Phase 1 · recruiting
NCT07331519 — Integrating Smoking Cessation With Low-dose CT-screening for Lung Cancer · NA · recruiting
NCT07210567 — Mindfulness-based Ecological Momentary Intervention for Smoking Cessation Among Cancer Survivors · NA · recruiting
NCT07129590 — Trauma-Informed Care for Smoking Cessation for Pregnancy · NA · recruiting

Other Rose Research Center, LLC trials

Trials by the same sponsor.

NCT06554873 — Adaptive Use of Nicotine Substitution to Maintain Smoking Reduction/Abstinence in Nicotine Responders · Phase 3 · completed
NCT05994703 — Assisting Smokers to Switch to an e-Cigarette by Accelerating Learning of Adaptive Habits Using D-cycloserine · Phase 2 · completed
NCT05855343 — Exploratory Study of Switching From Combustible Cigarettes to the BIDI E-cigarette · NA · completed
NCT05205811 — The Effects of Combination Zonisamide and Bupropion on Switching to an Electronic Cigarette · Phase 3 · completed
NCT04868253 — Efficacy and Safety of Combination EMB-001 as a Potential Smoking Cessation Treatment · Phase 2, PHASE3 · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06088862 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Rose Research Center, LLC
Last refreshed: 30 March 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06088862.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing