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Nicotine replacement therapy

Phase 2

Smoking Cessation | Small molecule | Psychiatry |Johnson & Johnson|Trials Updated: Jul 10, 2012

Nicotine replacement therapy development status

Highest phase Phase 2
Registered trials 5 across 5 sponsors since Mar 2011

Nicotine replacement therapy target and mechanism

Molecular targetCHRNB2, CHRNA4
Target classAgonist
ModalitySmall molecule
ChEMBLCHEMBL3

Also known as NRT

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment258

FDA Designations

No designations recorded

Nicotine replacement therapy clinical trials

Nicotine replacement therapy · 1 trial · 1 indication

Phase 2 1
NCT00764439Pilot Study of a New Nicotine Replacement TherapySmoking Cessation
COMPLETED258 Analytics
PHASE2COMPLETED
Pilot Study of a New Nicotine Replacement Therapy
Smoking CessationUnlock trial analytics

Study Endpoints

Primary Endpoints

Mean hourly and daily number of doses used
throughout study

Secondary Endpoints

Mean number of NRT use occasions per day
Week 1, 2, and 3
Ratings of craving/urge to smoke and withdrawal symptoms
Day 1-14, and Day 20
Self-reported continuous abstinence from smoking, verified by an exhaled CO level of less than 10 ppm
Day 1-21
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1ACTIVE_COMPARATORStandard NRT user direction
2EXPERIMENTALNovel NRT user direction

Interventions

NameTypeDescription
Nicotine replacement therapyDRUGNicotine replacement therapy with Standard NRT user direction
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Eligibility Criteria

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

Inclusion Criteria: * 18 years or older male and female cigarette smokers motivated and willing to stop smoking * female participants of child-bearing potential should use a medically acceptable means of birth control * evidence of a personally signed and dated informed consent document indicating ...

Countries:United Kingdom
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Frequently asked questions about Nicotine replacement therapy

What is nicotine replacement therapy used for?

Nicotine replacement therapy is used for smoking cessation. It is a small molecule treatment being developed by Johnson & Johnson (ticker: JNJ) for people who want to quit smoking. The therapy is in Phase 2 clinical development and has been studied in adults aged 18 years and older.

How does nicotine replacement therapy work?

Nicotine replacement therapy works as an agonist at the CHRNB2 and CHRNA4 targets. By acting on these nicotinic acetylcholine receptor subunits, it is designed to help manage nicotine withdrawal and craving during smoking cessation. This mechanism is distinct from simply delivering nicotine without receptor selectivity.

Who is developing nicotine replacement therapy?

Johnson & Johnson, which trades under the ticker JNJ, is the developer of this nicotine replacement therapy. The company is responsible for advancing the program, which is currently in Phase 2 clinical development for smoking cessation.

What phase is nicotine replacement therapy in?

Nicotine replacement therapy is in Phase 2 clinical development. It is an investigational treatment and has not been approved by the FDA. The program has completed one Phase 2 trial and currently has no active trials listed.

What clinical trials is nicotine replacement therapy in?

Nicotine replacement therapy has been evaluated in one completed Phase 2 trial, NCT00764439, titled "Pilot Study of a New Nicotine Replacement Therapy." The trial enrolled 258 participants in the United Kingdom, was randomized and active-controlled, and included adults 18 years and older of all sexes.