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Nicotine Patch

Phase 4

Smoking Cessation | Small molecule | Psychiatry |Pfizer, Inc.|Trials Updated: Oct 13, 2026

Nicotine Patch development status

Highest phase Phase 4 (NCT02162849)
Phase scored for PFEPhase 1
Registered trials 12 across 7 sponsors since Sep 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment630

FDA Designations

No designations recorded

Nicotine Patch clinical trials

Nicotine Patch · 1 trial · 1 indication

Early Phase 1 1
NCT03059940Smoking Cessation Intervention During Low Dose CT (LDCT) Screening for Lung CancerSmoking Cessation
ACTIVE NOT_RECRUITING630 Analytics
EARLY_PHASE1ACTIVE NOT_RECRUITING
Smoking Cessation Intervention During Low Dose CT (LDCT) Screening for Lung Cancer
Smoking CessationUnlock trial analytics

Study Endpoints

Primary Endpoints

Smoking Abstinence Rate
6 months

Statistical power will focus on primary objective. Primary analyses use intention-to-treat (ITT) principles, with missing observations imputed as smoking.

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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Quitline (QL) GroupEXPERIMENTALQuestionnaires completed at baseline and at 6 weeks, 12 weeks, and 6 months after the CT scan. CO level measured at baseline and at 6 weeks, 12 weeks, and 6 months after the CT scan. Participants have a CT scan of chest to look for signs of lung cancer. Participants watch a short video about lung cancer, CT scans, and smoking cessation. Brief cessation counseling given by LDCT provider. Participants given shared decision making and discussion about screening with the LDCT provider. Participants referred to the Quitline for counseling and NRT (nicotine patch). Participants have 5 smoking cessation counseling sessions over the next 12 weeks.
Quitline-Rx (QL-Rx) GroupEXPERIMENTALQuestionnaires completed at baseline and at 6 weeks, 12 weeks, and 6 months after the CT scan. CO level measured at baseline and at 6 weeks, 12 weeks, and 6 months after the CT scan. Participants have a CT scan of chest to look for signs of lung cancer. Participants watch a short video about lung cancer, CT scans, and smoking cessation. Brief cessation counseling given by LDCT provider. LDCT provider and patient discuss options for pharmacotherapy. Participants referred to the Quitline for counseling. Participants have 5 smoking cessation counseling sessions over the next 12 weeks.
Integrated Care (IC) GroupEXPERIMENTALQuestionnaires completed at baseline and at 6 weeks, 12 weeks, and 6 months after the CT scan. CO level measured at baseline and at 6 weeks, 12 weeks, and 6 months after the CT scan. Participants have a CT scan of chest to look for signs of lung cancer. Participants watch a short video about lung cancer, CT scans, and smoking cessation. Brief cessation counseling given by LDCT provider. Participant referred to Tobacco Treatment Program (TTP). TTP provides 4-8 counseling sessions and pharmacotherapy over a 10-12 week period,

Interventions

NameTypeDescription
QuestionnairesBEHAVIORALQuestionnaires completed at baseline and at 6 weeks, 12 weeks, and 6 months after the CT scan.
Low Dose Computed Tomography ScanPROCEDUREParticipants have a CT scan of chest to look for signs of lung cancer.
Shared Decision Making + VideoOTHERParticipants given shared decision making and discussion about screening with the LDCT provider. Participants watch a short video about lung cancer, CT scans, and smoking cessation.
Cessation CounselingBEHAVIORALBrief cessation counseling given by LDCT provider.
QuitlineBEHAVIORALParticipants referred to the Quitline for counseling. Participants have 5 smoking cessation counseling sessions over the next 12 weeks.
Pharmacotherapy DiscussionBEHAVIORALParticipant informed of the risk, benefits and relative efficacy of cessation medications and to assess their medication preferences, expectations and medical suitability for either option. At the conclusion of this conversation the patient is provided with an initial supply of the medication jointly decided between provider and patient.
Nicotine PatchDRUGNicotine patch dispensed. Dosing at physician's discretion.
Anti-Smoking DrugDRUGVarenicline or Buproprion prescribed by study doctor with directions of when and how much of anti-smoking drug that should be taken each time.
Tobacco Treatment ProgramBEHAVIORALParticipant referred to Tobacco Treatment Program (TTP). TTP provides 4-8 counseling sessions and pharmacotherapy over a 10-12 week period,
Carbon Monoxide (CO) Level TestOTHERParticipant asked to blow air through a CO-measuring device.
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Eligibility Criteria

Age Range50 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Age: 50 or older * Meets guidelines for lung cancer screening, as determined by radiology team * Reports being a daily or non-daily smoker (any self-reported smoking in the past 30days) and is interested in treatment that might change smoking behavior. * Able to follow verbal ...

Countries:United States
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