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Showing 1–22 of 22 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Nicotine Bitartrate Lozenge 4mg Clear all
Completed Phase 1 Interventional Accepts healthy volunteers Results available

To Assess the Bioequivalence of the 4mg Prototype Mini Nicotine Lozenge to the Reference Product (Nicorette) in Healthy Smokers

NCT03543137
View directory record Official record
Conditions
Tobacco Use Disorder
Interventions
Nicotine Prototype Mini lozenge, Nicorette Mini Lozenge
Drug
Lead sponsor
GlaxoSmithKline
Industry
Eligibility
19 Years to 55 Years
Enrollment
37 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2018
U.S. locations
1
States / cities
Lincoln, Nebraska
Source: ClinicalTrials.gov public record
Updated Dec 3, 2019 · Synced Sep 28, 2026, 5:52 AM EDT
Completed Not applicable Interventional Results available

Mindfulness-based Smoking Cessation Enhanced With Mobile Technology

NCT04965181
View directory record Official record
Conditions
Cigarette Smoking
Interventions
Mindfulness-Based Addiction Treatment, Nicotine Replacement Therapy, Self-help materials, iQuit Mindfully
Behavioral · Drug
Lead sponsor
Georgia State University
Other
Eligibility
18 Years and older
Enrollment
504 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2025
U.S. locations
1
States / cities
Atlanta, Georgia
Source: ClinicalTrials.gov public record
Updated Feb 26, 2026 · Synced Sep 28, 2026, 5:52 AM EDT
Completed Not applicable Interventional Results available

Goal2Quit + NRT Sampling

NCT03837379
View directory record Official record
Conditions
Cigarette Smoking, Smoking Cessation, Depression
Interventions
Treatment as Usual, Goal2Quit + NRT Sampling
Behavioral · Combination Product
Lead sponsor
Medical University of South Carolina
Other
Eligibility
18 Years and older
Enrollment
164 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2022
U.S. locations
1
States / cities
Charleston, South Carolina
Source: ClinicalTrials.gov public record
Updated May 16, 2023 · Synced Sep 28, 2026, 5:52 AM EDT
Completed Not applicable Interventional Accepts healthy volunteers

Preliminary Investigation of Novel Methods to Reduce Children's Secondhand Smoke Exposure

NCT01935713
View directory record Official record
Conditions
Secondhand Smoke
Interventions
Nicotine polacrilex, Electronic Cigarette, Dissolvable Tobacco Lozenge
Drug
Lead sponsor
University of Oklahoma
Other
Eligibility
18 Years to 65 Years
Enrollment
89 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2012
U.S. locations
1
States / cities
Oklahoma City, Oklahoma
Source: ClinicalTrials.gov public record
Updated Apr 5, 2026 · Synced Sep 28, 2026, 5:52 AM EDT
Recruiting Phase 3 Interventional Accepts healthy volunteers

Integrating Financial Coaching and Smoking Cessation Coaching

NCT05154669
View directory record Official record
Conditions
Smoking
Interventions
Financial counseling, Nicotine Replacement Therapy Agent - Patches, Nicotine Replacement Therapy Agent - Lozenges, Nicotine Replacement Therapy Agent - Gum
Other · Drug
Lead sponsor
NYU Langone Health
Other
Eligibility
18 Years to 100 Years
Enrollment
602 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2022 – 2029
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated May 3, 2026 · Synced Sep 28, 2026, 5:52 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Effect of Nicotine on Brain Reward Pathways

NCT02346539
View directory record Official record
Conditions
Depressive Disorder
Interventions
Nicotine polacrilex
Drug
Lead sponsor
Mclean Hospital
Other
Eligibility
18 Years to 45 Years
Enrollment
46 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2015 – 2017
U.S. locations
1
States / cities
Belmont, Massachusetts
Source: ClinicalTrials.gov public record
Updated Mar 21, 2018 · Synced Sep 28, 2026, 5:52 AM EDT
Not yet recruiting Phase 4 Interventional

Evaluating an Innovative Tobacco Treatment Approach for Veterans in Substance Use Treatment

NCT07809854
View directory record Official record
Conditions
Cigarette Smoking, Veterans
Interventions
Healthy Changes Nicotine Replacement Therapy (NRT), Cessation Treatment Nicotine Replacement Therapy (NRT), Cessation Treatment Counseling, Healthy Changes Counseling
Drug · Behavioral
Lead sponsor
VA Office of Research and Development
Federal
Eligibility
18 Years and older
Enrollment
112 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2027 – 2031
U.S. locations
1
States / cities
Madison, Wisconsin
Source: ClinicalTrials.gov public record
Updated Sep 13, 2026 · Synced Sep 28, 2026, 5:52 AM EDT
Recruiting Phase 4 Interventional

The Options 2 Study

NCT06595459
View directory record Official record
Conditions
Smoker, Smoking Cessation
Interventions
Nicotine Pouches, Mini Nicotine lozenges
Drug
Lead sponsor
University of Wisconsin, Madison
Other
Eligibility
21 Years and older
Enrollment
300 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2029
U.S. locations
1
States / cities
Madison, Wisconsin
Source: ClinicalTrials.gov public record
Updated Jun 21, 2026 · Synced Sep 28, 2026, 5:52 AM EDT
Completed Phase 1 Interventional Results available

Feasibility Trial of a Tailored Smoking Cessation App for People With Serious Mental Illness

NCT03069482
View directory record Official record
Conditions
Nicotine Addiction, Serious Mental Illness
Interventions
Learn to Quit App, Nicotine patch, Nicotine lozenge, Technical Coaching, NCI QuitGuide App
Device · Drug · Behavioral
Lead sponsor
Duke University
Other
Eligibility
18 Years and older
Enrollment
63 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2019
U.S. locations
1
States / cities
Durham, North Carolina
Source: ClinicalTrials.gov public record
Updated Nov 9, 2020 · Synced Sep 28, 2026, 5:52 AM EDT
Completed Phase 2 Interventional Results available

Free Samples for Health

NCT05627596
View directory record Official record
Conditions
Cigarette Smoking
Interventions
Ask-Advise-Refer, Nicotine Patch, 14 Mg/24 Hr Transdermal Film, Extended Release, Nicotine lozenge
Behavioral · Drug
Lead sponsor
Sandra Japuntich
Other
Eligibility
18 Years and older
Enrollment
1,239 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2025
U.S. locations
1
States / cities
Minneapolis, Minnesota
Source: ClinicalTrials.gov public record
Updated Jul 23, 2026 · Synced Sep 28, 2026, 5:52 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Pharmacokinetics of Nicotine Sublingual Tablets Versus Nicorette Lozenge in Healthy Smokers

NCT02906995
View directory record Official record
Conditions
Tobacco Use Disorder, Cigarette Smoking
Interventions
Sublingual tablet 4 mg versus Nicorette Lozenge 4mg
Drug
Lead sponsor
Friends Research Institute, Inc.
Other
Eligibility
18 Years to 45 Years
Enrollment
24 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2017
U.S. locations
1
States / cities
Raleigh, North Carolina
Source: ClinicalTrials.gov public record
Updated Dec 3, 2017 · Synced Sep 28, 2026, 5:52 AM EDT
Completed Phase 1Phase 2 Interventional Results available

STARS (Smoking Treatment And Remote Sampling) Study

NCT04525755
View directory record Official record
Conditions
Smoking, Smoking Cessation, Tobacco Smoking, Cigarette Smoking
Interventions
Varenicline 0.5 MG, Nicotine Replacement Therapy (NRT)
Drug
Lead sponsor
Medical University of South Carolina
Other
Eligibility
18 Years and older
Enrollment
652 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2025
U.S. locations
1
States / cities
Charleston, South Carolina
Source: ClinicalTrials.gov public record
Updated Feb 16, 2026 · Synced Sep 28, 2026, 5:52 AM EDT
Completed Not applicable Interventional

Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings

NCT05030272
View directory record Official record
Conditions
Tobacco Use Disorder, Mental Illness, Recurring Major Depressive Disorder, Bipolar Disorder, Schizophrenia, Schizoaffective Disorder, Persistent Depressive Disorder
Interventions
Quit on the Go App (formerly "Learn to Quit " App), Brief advice, Nicotine patch, Smartphone coaching, Nicotine gum, Nicotine Lozenges
Device · Behavioral · Drug
Lead sponsor
Wake Forest University Health Sciences
Other
Eligibility
18 Years and older
Enrollment
343 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2025
U.S. locations
3
States / cities
Buffalo, New York • Durham, North Carolina • Winston-Salem, North Carolina
Source: ClinicalTrials.gov public record
Updated Feb 26, 2026 · Synced Sep 28, 2026, 5:52 AM EDT
Completed Phase 4 Interventional Accepts healthy volunteers Results available

Treating Caregivers Who Smoke at AFCH

NCT06051474
View directory record Official record
Conditions
Smoking, Smoking Cessation
Interventions
Nicotine Replacement Product
Drug
Lead sponsor
University of Wisconsin, Madison
Other
Eligibility
18 Years and older
Enrollment
23 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2024 – 2025
U.S. locations
1
States / cities
Madison, Wisconsin
Source: ClinicalTrials.gov public record
Updated Apr 15, 2026 · Synced Sep 28, 2026, 5:52 AM EDT
Not yet recruiting Phase 2 Interventional

DOSE-UP: Dose Optimization for Smoking and E-Cigarette Use Pharmacotherapy

NCT07754578
View directory record Official record
Conditions
Dual Use of Cigarettes and E-cigarettes
Interventions
Text- and web-based support, Nicotine Replacement Therapy (NRT, nicotine patch), Nicotine replacement therapy lozenge
Behavioral · Drug
Lead sponsor
Medical University of South Carolina
Other
Eligibility
18 Years and older
Enrollment
321 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2031
U.S. locations
1
States / cities
Charleston, South Carolina
Source: ClinicalTrials.gov public record
Updated Aug 10, 2026 · Synced Sep 28, 2026, 5:52 AM EDT
Completed Phase 2 Interventional Results available

CAN-DOSE Study: Cessation With Augmented Nicotine for Dual Use Of Smoking and E-cigarettes

NCT06087328
View directory record Official record
Conditions
Smoking Cessation, Electronic Cigarette Use, Cigarette Smoking
Interventions
Regular Nicotine patch and lozenge dose, Augmented Nicotine patch and lozenge dose
Drug
Lead sponsor
Medical University of South Carolina
Other
Eligibility
18 Years and older
Enrollment
46 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2024
U.S. locations
1
States / cities
Charleston, South Carolina
Source: ClinicalTrials.gov public record
Updated Nov 25, 2025 · Synced Sep 28, 2026, 5:52 AM EDT
Terminated Phase 2 Interventional Accepts healthy volunteers Results available

Effectiveness of Combination Varenicline and Oral Nicotine Replacement Therapy (COMBO)

NCT03722966
View directory record Official record
Conditions
Smoking Cessation
Interventions
Varenicline, Oral Nicotine Replacement Therapy (NRT), Medication Reminders, Tobacco Cessation Counseling
Drug · Behavioral
Lead sponsor
University of Oklahoma
Other
Eligibility
18 Years to 65 Years
Enrollment
34 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2020 – 2022
U.S. locations
1
States / cities
Oklahoma City, Oklahoma
Source: ClinicalTrials.gov public record
Updated Feb 5, 2024 · Synced Sep 28, 2026, 5:52 AM EDT
Completed Not applicable Interventional Accepts healthy volunteers

A Study to Assess the Pharmacokinetics of Oral Nicotine Pouches and Lozenges in Healthy Adults

NCT04755348
View directory record Official record
Conditions
Tobacco Use, Tobacco Smoking, Cigarette Smoking
Interventions
Product A, Product B, Product C, Product D, Product E, Product F
Other
Lead sponsor
British American Tobacco (Investments) Limited
Industry
Eligibility
21 Years to 60 Years
Enrollment
36 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2021
U.S. locations
1
States / cities
Overland Park, Kansas
Source: ClinicalTrials.gov public record
Updated Mar 29, 2021 · Synced Sep 28, 2026, 5:52 AM EDT
Terminated Phase 3 Interventional Accepts healthy volunteers

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

NCT06088862
View directory record Official record
Conditions
Smoking Cessation, Harm Reduction
Interventions
Nicoderm, Nicorette 4Mg Chewing Gum, Nicorette Lozenge Product, BIDI e-cigarette, on!
Drug · Other
Lead sponsor
Rose Research Center, LLC
Industry
Eligibility
22 Years to 65 Years
Enrollment
4 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2023 – 2024
U.S. locations
2
States / cities
Charlotte, North Carolina • Raleigh, North Carolina
Source: ClinicalTrials.gov public record
Updated Mar 29, 2025 · Synced Sep 28, 2026, 5:52 AM EDT
Completed Phase 3 Interventional Accepts healthy volunteers

Adaptive Use of Nicotine Substitution to Maintain Smoking Reduction/Abstinence in Nicotine Responders

NCT06554873
View directory record Official record
Conditions
Smoking Cessation, Harm Reduction
Interventions
Nicoderm, Nicorette 4Mg Chewing Gum, Nicorette Lozenge Product, NJOY e-cigarette, on!
Drug · Other
Lead sponsor
Rose Research Center, LLC
Industry
Eligibility
22 Years to 65 Years
Enrollment
150 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2024 – 2025
U.S. locations
2
States / cities
Charlotte, North Carolina • Raleigh, North Carolina
Source: ClinicalTrials.gov public record
Updated Feb 5, 2026 · Synced Sep 28, 2026, 5:52 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers Results available

Oral Mucosal Effects In Adult Smokers Associated With Two Nicotine Lozenge Formulations

NCT03087786
View directory record Official record
Conditions
Safety Issues
Interventions
Nicotine Bitartrate Lozenge 4mg, Nicotine Polacrilex 4Mg Lozenge
Drug
Lead sponsor
Niconovum USA
Industry
Eligibility
18 Years and older
Enrollment
100 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2017
U.S. locations
1
States / cities
Newark, New Jersey
Source: ClinicalTrials.gov public record
Updated Jan 10, 2021 · Synced Sep 28, 2026, 5:52 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers Results available

Persistence-Targeted Smoking Cessation

NCT01654107
View directory record Official record
Conditions
Tobacco Use Disorder
Interventions
Persistence Targeted Smoking Cessation, Clearing The Air, Nicotine lozenge
Behavioral · Drug
Lead sponsor
Rutgers, The State University of New Jersey
Other
Eligibility
18 Years to 64 Years
Enrollment
58 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2012 – 2014
U.S. locations
1
States / cities
New Brunswick, New Jersey
Source: ClinicalTrials.gov public record
Updated Aug 20, 2017 · Synced Sep 28, 2026, 5:52 AM EDT