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Nicotine replacement therapy

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment258

FDA Designations

No designations recorded

Clinical trial landscape

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 being developed by Johnson & Johnson (JNJ) for this indication. The therapy is currently in Phase 2 clinical development, with one completed trial involving 258 participants in the United Kingdom.

Who makes Nicotine replacement therapy?

Johnson & Johnson (JNJ) is developing Nicotine replacement therapy. The therapy is a small molecule intended for smoking cessation. It is currently in Phase 2 clinical development, with one completed trial that enrolled 258 participants.

What phase is Nicotine replacement therapy in?

Nicotine replacement therapy is in Phase 2 clinical development. It is an investigational therapy for smoking cessation and has not been approved by regulatory authorities. One Phase 2 trial has been completed, involving 258 participants in the United Kingdom.

What clinical trials is Nicotine replacement therapy in?

Nicotine replacement therapy has one completed clinical trial, NCT00764439, titled 'Pilot Study of a New Nicotine Replacement Therapy'. This Phase 2 trial enrolled 258 participants with smoking cessation as the condition, was conducted in the United Kingdom, and included adults aged 18 years and older.

Is Nicotine replacement therapy the same as other nicotine replacement products?

Nicotine replacement therapy is a specific investigational product being developed by Johnson & Johnson. It is not described as being the same as any other named product. The therapy is in Phase 2 development for smoking cessation, with one completed trial.