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Nicotine Gum

Phase 4

Smoking Cessation | Small molecule | Psychiatry |Johnson & Johnson|Trials Updated: Apr 25, 2012

Nicotine Gum development status

Highest phase Phase 4 (NCT00749463)
Phase scored for JNJPhase 3
Registered trials 6 across 3 sponsors since Sep 2008

Nicotine Gum target and mechanism

Molecular targetCHRNB2, CHRNA4
Target classAgonist
ModalitySmall molecule
ChEMBLCHEMBL3

Also known as Nicorette® Gum

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment314

FDA Designations

No designations recorded

Nicotine Gum clinical trials

Nicotine Gum · 1 trial · 1 indication

Phase 3 1
NCT00840242Smoking Reduction or Cessation With Nicotine Replacement TherapySmoking Cessation
COMPLETED314 Analytics
PHASE3COMPLETED
Smoking Reduction or Cessation With Nicotine Replacement Therapy
Smoking CessationUnlock trial analytics

Study Endpoints

Primary Endpoints

Reduction in number of smoked cigarettes/day verified by carbon monoxide (CO) levels
Baseline to 6 weeks, 3 and 4 months

Secondary Endpoints

Changes in laboratory values of cardiovascular risk factors
Baseline up to 12 months
Changes in clinical and laboratory exposure parameters
Baseline up to 12 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Nicotine gumEXPERIMENTALNicotine gum
Placebo gumPLACEBO_COMPARATORPlacebo gum
Nicotine inhalerACTIVE_COMPARATORNicotine inhaler
Placebo inhalerPLACEBO_COMPARATORPlacebo inhaler

Interventions

NameTypeDescription
Nicotine gumDRUG8-12 pieces per day, maximum 24 daily
Placebo gumDRUG8-12 pieces per day, maximum 24 daily
Nicotine inhalerDRUG6-12 cartridges per day, maximum 12 daily
Placebo inhalerDRUG6-12 cartridges per day, maximum 12 daily
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Age above 18 * Smoking \>/= 15 cigarettes/day * Having smoked for 3 years or more * CO \>/= 10ppm at inclusion * Want to reduce smoking * Prepared to adhere to the protocol * Willing to provide signed informed consent * Having made at least one serious attempt to quit smoking ...

Countries:Czechia
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Frequently asked questions about Nicotine Gum

What is nicotine gum used for?

Nicotine gum is used for smoking cessation, helping people reduce or quit cigarette smoking. It is a nicotine replacement therapy developed by Johnson & Johnson, which trades under the ticker JNJ. The gum falls within the psychiatry therapeutic area and is classified as a small molecule.

How does nicotine gum work?

Nicotine gum works as an agonist at the CHRNB2 and CHRNA4 nicotinic acetylcholine receptor targets. By delivering nicotine through the buccal mucosa, it stimulates these receptors to ease withdrawal symptoms and cravings when a person stops smoking. This supports smoking reduction or cessation as part of a quit attempt.

Who makes nicotine gum?

Nicotine gum is developed by Johnson & Johnson, which trades under the ticker JNJ. The company is the developer associated with this nicotine replacement therapy product for smoking cessation.

What phase is nicotine gum in?

Nicotine gum has been studied in Phase 3 clinical development for smoking cessation. It is an investigational asset in this dataset rather than a newly approved product, and its recorded trial activity has concluded. One Phase 3 trial has been completed, with no active trials currently listed.

What clinical trials is nicotine gum in?

Nicotine gum has been evaluated in the completed Phase 3 trial NCT00840242, titled Smoking Reduction or Cessation With Nicotine Replacement Therapy. That trial enrolled 314 participants in Czechia, was randomized, double blind, and placebo controlled, and included adults aged 18 years and older of all sexes.

Is nicotine gum the same as nicotine replacement therapy?

Nicotine gum is a form of nicotine replacement therapy, a broader category of products that deliver nicotine to help people quit smoking. The completed Phase 3 trial NCT00840242 studied smoking reduction or cessation with nicotine replacement therapy, and nicotine gum is one such delivery method within that class.