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Nicotine lozenge

Phase 2

Cigarette Smoking | Small molecule | Other |National Healthcare Corp.|Last Updated: May 30, 2024

Target and mechanism

Molecular targetCHRNB2, CHRNA4
Target classAgonist
ModalitySmall molecule
ChEMBLCHEMBL3

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment1,200

FDA Designations

No designations recorded

Clinical trial landscape

Nicotine lozenge · 1 trial · 1 indication

Phase 2 1
NCT05627596Free Samples for HealthCigarette Smoking
ENROLLING BY_INVITATION1,200 Analytics
PHASE2ENROLLING BY_INVITATION
Free Samples for Health
Cigarette SmokingUnlock trial analytics

Study Endpoints

Primary Endpoints

7-day biochemically confirmed point prevalence abstinence
6 months post baseline

Proportion reporting no smoking in the 7 days prior to the 6-month follow-up timepoint and having an exhaled carbon monoxide value of less than 6 parts per million

Secondary Endpoints

7-day self-reported point prevalence abstinence
1 month post baseline
24-hour intentional quit attempts
6 months post baseline
Smoking heaviness
6 months post baseline
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelFACTORIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Electric ToothbrushACTIVE_COMPARATORParticipants will receive the Ask-Advise-Refer intervention which includes an oral health practitioner asking about their tobacco use, advising them to quit smoking, and referring them to the state quitline. They will also receive a sample bag including information about smoking and oral health, the state quitline, and an electric toothbrush.
Nicotine Replacement TherapyEXPERIMENTALParticipants will receive the Ask-Advise-Refer intervention which includes an oral health practitioner asking about their tobacco use, advising them to quit smoking, and referring them to the state quitline. They will also receive a sample bag including information about smoking and oral health, the state quitline, and a two week supply of 14mg nicotine patches and 4mg lozenges.

Interventions

NameTypeDescription
Ask-Advise-ReferBEHAVIORALAll patients will be asked if they smoke, advised to quit, and referred to the state quitline
Nicotine Patch, 14 Mg/24 Hr Transdermal Film, Extended ReleaseDRUG14 mg transdermal nicotine patch
Nicotine lozengeDRUG4mg nicotine lozenge
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * ≥ 18 years old * smokes at least 1 combustible cigarette per day on at least 25 days of the month Exclusion Criteria: * does not own a smartphone with internet access * myocardial infarction or stroke in the past 3 months * pregnant or breastfeeding * use of tobacco cessatio...

Countries:United States
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Frequently asked questions about Nicotine lozenge

What is Nicotine lozenge used for?

Nicotine lozenge is used for cigarette smoking cessation. It is an investigational small molecule being developed by National Healthcare Corp. (NHC) for this indication. The drug is currently in Phase 2 clinical development.

Who makes Nicotine lozenge?

Nicotine lozenge is being developed by National Healthcare Corp., which trades under the ticker NHC. The company is conducting a Phase 2 clinical trial for the drug in the United States.

What phase is Nicotine lozenge in?

Nicotine lozenge is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. The drug is being studied for its use in cigarette smoking cessation.

What clinical trials is Nicotine lozenge in?

Nicotine lozenge is being studied in a Phase 2 clinical trial with the identifier NCT05627596, titled "Free Samples for Health." This trial is enrolling by invitation and has an enrollment of 1,200 participants in the United States.

Is Nicotine lozenge FDA approved?

Nicotine lozenge is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for cigarette smoking cessation. The drug has not yet completed clinical trials or received regulatory approval.