Nicorette

(Nicotine)

ApprovedSmall molecule

Nicotine is used to help people quit smoking by reducing cravings and withdrawal symptoms when they stop using tobacco products. It's available in forms like patches, gum, lozenges, and inhalers that deliver nicotine without the harmful chemicals in cigarette smoke.[2] Nicorette is currently approved and in use across 38 indications[4].[1]

Nicorette is one of 600 small molecule programs targeting Smoking Cessation. It is currently in Approved.

Indications

302

Total Trials

Active Trials

599

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Smoking CessationActive, not recruiting

Tobacco CessationCompleted

Attention Deficit Hyperactivity DisorderApproved

Subarachnoid HemorrhageActive, not recruiting

Substance AbuseActive, not recruiting

Wound HealingActive, not recruiting

Lung CarcinomaActive, not recruiting

Drug DependenceApproved

TuberculosisApproved

Pulmonary SarcoidosisApproved

Smoking CessationApproved

Active, not recruiting

Tobacco CessationPhase 2

Completed

Attention Deficit Hyperactivity DisorderApproved

Approved

Subarachnoid HemorrhagePreclinical

Active, not recruiting

Substance AbusePreclinical

Active, not recruiting

Wound HealingPreclinical

Active, not recruiting

Lung CarcinomaPreclinical

Active, not recruiting

Drug DependenceApproved

Approved

TuberculosisApproved

Approved

Pulmonary SarcoidosisApproved

Approved

Showing 10 of 37 indications

Competition

Competitive Landscape

206 competitors in Lung Cancer

#DrugCompanyPhaseTrials

Keytruda

Merck & Co.

Phase 3

33 2

Opdivo

Bristol-Myers Squibb

Phase 3

20 3

Tagrisso

AstraZeneca

Phase 3

19 4

Nicorette

Pfizer

Approved

2 5

Beyfortus

BeiGene

Phase 3

10 6

Yervoy

Bristol-Myers Squibb

Phase 3

10 7

Abraxane

Bristol-Myers Squibb

Phase 3

7 8

Imjudo

AstraZeneca

Phase 3

6 9

Tecentriq

Roche

Phase 3

6 10

DATROWAY

Daiichi Sankyo

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

N/AActive, not recruiting

Treatment

NCT05014282

Q4 2026

N/ARecruiting

Thoracic Surgery

NCT07250230

Q1 2027

Phase 1Recruiting

Study completion

NCT06096714

Phase 1Active, not recruiting

Lung Cancer

NCT04200534

Phase 1Recruiting

Smoking

NCT05665465

Q3 2027

Phase 2/3Recruiting

Smoking Cessation

NCT05413122

Clinical

Trials by Indication[1]

Smoking Cessation47 trials

Behavioral Activation Intervention, Reward Processing, and Youth Smoking Cessation

Completed·UUniversity of Maryland, College Park·Phase 3·NCT01351766·39 enrolled

Combination Nicotine Patch / Lorcaserin for Smoking Cessation

Completed·—·Phase 2·NCT02906644·97 enrolled

Metabolism-informed Care for Smoking Cessation

Completed·VVanderbilt University Medical Center·N/A·NCT03227679·82 enrolled

Show 44 more trials

Supplemental Nicotine Administration for Smoking Cessation in Posttraumatic Stress Disorder (PTSD)

Completed·—·N/A·NCT01055886·69 enrolled

Nicotine Patch Pretreatment for Smoking Cessation in PTSD

Completed·UUS Department of Veterans Affairs·Phase 1·NCT00625131·87 enrolled

Smoking Cessation Treatment for Head and Neck Cancer Patients

Terminated·YYale University·Phase 1·NCT00931021·7 enrolled

Exenatide for Smoking Cessation and Prevention of Weight Gain

Completed·TThe University of Texas Health Science Center, Houston·Phase 2·NCT05610800·140 enrolled

The Use of Nicotine Patches Together With E-cigarettes (With and Without Nicotine) for Smoking Cessation

Completed·UUniversity of Auckland, New Zealand·Phase 3·NCT02521662·1,124 enrolled

Impact of Smoking Cessation on Sleep - 5

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 4·NCT00132821·59 enrolled

Combinations of Pharmacologic Smoking Cessation Treatments

Completed·UUS Department of Veterans Affairs·Phase 1·NCT00018187

Assessment of a Teachable Moment for Smoking Cessation

Completed·UUniversity of Pennsylvania··NCT00596440·234 enrolled

Neuroimaging Reward, Behavioral Treatment, and Smoking Cessation

Completed·MMaggie M Sweitzer, PhD·Phase 1/2·NCT02927847·35 enrolled

Opioids and Smoking Cessation

Withdrawn·UUniversity of Houston·Phase 4·NCT03857139

Extended Treatment for Smoking Cessation

Completed·SStanford University·Phase 4·NCT01330043·223 enrolled

iQuit Mindfully: Text Messaging for Smoking Cessation

Completed·GGeorgia State University·N/A·NCT03029819·72 enrolled

Community-based Smoking Cessation Treatment for Adults With High Stress Sensitivity.

Recruiting·—·Phase 3·NCT06053567·360 enrolled

Heart Rate Variability Biofeedback for Smoking Cessation

Completed·RRutgers, The State University of New Jersey·Phase 2·NCT03972137·10 enrolled

UW-CTRI Triple Medication Smoking Cessation Study

Completed·UUniversity of Wisconsin, Madison·Phase 4·NCT02681510·36 enrolled

Text Messaging for Smoking Cessation in College Health Clinics

Completed·YYale University·N/A·NCT02191033·40 enrolled

Smoking Cessation Intervention

Terminated·UUniversity of Florida·Phase 4·NCT03072511·23 enrolled

Association of Functional COMT Val108/Met Polymorphism With Smoking Cessation in Nicotine Replacement Therapy

Completed·NNational Institute on Drug Dependence, China·Phase 4·NCT01980550·250 enrolled

Enhancing a High School Based Smoking Cessation Program

Completed·YYale University·N/A·NCT01145001·154 enrolled

Varenicline or Nicotine Patch in Promoting Smoking Cessation Among Current Smokers

Completed·RRoswell Park Cancer Institute·N/A·NCT01771627·300 enrolled

Concurrent Bupropion / Varenicline for Smoking Cessation

Completed·—·Phase 3·NCT01303861·702 enrolled

Adjustment of DOses of NIcotine in Smoking Cessation (ADONIS)

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 4·NCT00235313·300 enrolled

An Evidence Based Smoking Cessation Program for Persons Living With HIV/AIDS (Project Legacy)

Withdrawn·MM.D. Anderson Cancer Center·N/A·NCT02029612

Study on the Model of Smoking Cessation Intervention and Service Ability Improvement

Unknown status·—··NCT01935505·2,000 enrolled

Do Treatments for Smoking Cessation Affect Alcohol Drinking? Study 1: Nicotine Replacement Therapy

Completed·YYale University·Phase 2·NCT00699556·22 enrolled

Smoking Cessation and Sexual Health in Men

Completed·UUniversity of Texas at Austin·Phase 1·NCT00833404·80 enrolled

Varenicline Versus Transdermal Nicotine Patch for Smoking Cessation in Patients With Coronary Heart Disease

Completed·OOttawa Heart Institute Research Corporation·Phase 4·NCT00959972·50 enrolled

Interactive Voice Response Technology to Mobilize Contingency Management for Smoking Cessation

Completed·UUConn Health·Phase 2·NCT01484717·90 enrolled

Evaluating a Telephone-Based Smoking Cessation Program Among People in the Military (The AFIII Study)

Completed·UUniversity of Tennessee·N/A·NCT00632411·1,298 enrolled

Pager-Assisted Smoking Cessation Treatment

Completed·UUniversity of California, San Francisco·N/A·NCT01207310·224 enrolled

Smoking Cessation Medications: Efficacy, Mechanisms and Algorithms

Completed·UUniversity of Wisconsin, Madison·Phase 4·NCT00332644·1,504 enrolled

Persistence Targeted Smoking Cessation in Serious Mental Illness (SMI)

Completed·RRutgers, The State University of New Jersey·N/A·NCT03873337·34 enrolled

Meclizine as a Potential Smoking Cessation Treatment

Completed·—·Phase 2·NCT01443858·146 enrolled

Innovative Interventions for Smoking Cessation

Completed·UUniversity of Minnesota·Phase 2·NCT01050569·235 enrolled

Behavioral Activation Intervention for Smoking Cessation in Smokers With Depressive Symptoms

Completed·UUniversity of Maryland, College Park·Phase 2·NCT01199380·184 enrolled

Evaluating Smoking Cessation Interventions for PWH in South Africa

Recruiting·JJohns Hopkins University·Phase 2/3·NCT05413122·660 enrolled

Coping Skills Treatment for Smoking Cessation

Completed·—·N/A·NCT01061528·116 enrolled

Efficacy and Safety Study of Nicotine Mint Lozenge (2mg and 4mg) in Smoking Cessation

Completed· GSK logo

GSK·Phase 3·NCT00985985·723 enrolled

Electronic Nicotine Delivery Systems as a Smoking Cessation Treatment

Withdrawn·—·Phase 2·NCT02487953

Varenicline and Combined NRT for Smoking Cessation

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 4·NCT02271919·631 enrolled

Feasibility Trial of a Tailored Smoking Cessation App for People With Serious Mental Illness

Completed·—·Phase 1·NCT03069482·63 enrolled

Internet-Administered Smoking Cessation Treatment for Overweight and Obese Smokers

Completed·YYale University·N/A·NCT01259466·54 enrolled

Using Machine Learning to Develop Just-in-Time Adaptive Interventions for Smoking Cessation

Completed·TThe University of Texas Health Science Center, Houston·N/A·NCT04839198·60 enrolled

Effectiveness of Various Smoking Cessation Therapies in Reducing Smoking in Adolescents - 1

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 2·NCT00158171·128 enrolled

Treatment11 trials

Nicotine Delivery Systems: Research & Treatment

Terminated·UUS Department of Veterans Affairs·N/A·NCT00108342·25 enrolled

Behavioral Intervention for Low Income Depressed Smokers in Drug Treatment

Completed·UUniversity of Maryland, College Park·Phase 1/2·NCT01372254·96 enrolled

Smoking Treatment and Exercise Program for Underserved Populations (STEP UP)

Completed·—·N/A·NCT02873754·11 enrolled

Show 8 more trials

Efficacy and Neural Correlates of Personalized Treatment With Transdermal Nicotine Replacement

Terminated·CCentre for Addiction and Mental Health·Phase 2/3·NCT02439944·18 enrolled

Identifying Treatments to Motivate Smokers to Quit

Completed·UUniversity of Wisconsin, Madison·Phase 4·NCT01122238·517 enrolled

Treatment to Quit Smoking

Completed·UUS Department of Veterans Affairs·Phase 2·NCT00018161

Motivation and Nicotine Patch Treatment for Under-served Smokers

Completed·TThe Miriam Hospital·N/A·NCT01684995

Physician-Initiated Stop-Smoking Program for Patients Receiving Treatment for Early-Stage Cancer

Completed·EEastern Cooperative Oncology Group·N/A·NCT00002520·434 enrolled

Varenicline or Nicotine Patch and Nicotine Gum in Helping Smokers in a Methadone Treatment Program Stop Smoking

Completed·—·N/A·NCT00790569·315 enrolled

Tobacco Treatment Comparison for Cancer Care

Completed·UUniversity of Wisconsin, Madison·Phase 4·NCT06218823·52 enrolled

Automated Video-Assisted Smoking Treatment for People Living With HIV

Active, not recruiting·HH. Lee Moffitt Cancer Center and Research Institute·N/A·NCT05014282·638 enrolled

Smoking11 trials

Completed·MMclean Hospital·N/A·NCT01588561·15 enrolled

Effects of Smoking Environments on Craving and Smoking (CameraCue2.0)

Completed·—·N/A·NCT02551692·125 enrolled

A Quit Smoking Study Using Smartphones

Completed·UUniversity of Wisconsin, Madison·N/A·NCT02164383·30 enrolled

Show 8 more trials

Counseling and Nicotine Replacement Therapy in Helping Adult Smokers Quit Smoking

Completed·FFox Chase Cancer Center·Phase 4·NCT00365508·642 enrolled

Smoking Termination Enhancement Project (STEP)

Completed·UUnknown Sponsor·Phase 3·NCT01065506·150 enrolled

Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings

Completed·WWake Forest University Health Sciences·N/A·NCT05030272·343 enrolled

Women Engaging in Quitting Smoking Together

Completed·RRhode Island Hospital·N/A·NCT02453659·100 enrolled

Neurobehavioral Mechanisms Linking Childhood Adversity to Increased Risk for Smoking

Recruiting·—·Phase 1·NCT05665465·150 enrolled

Computer-Assisted Scheduling of Nicotine Inhaler Use in Participants Who Plan to Stop Smoking

Completed·PPersonal Improvement Computer Systems·N/A·NCT00021138

Offering Nicotine Patches to All Households in a Municipality With High Smoking Rates

Completed·CCentre for Addiction and Mental Health··NCT04534231·123 enrolled

Post Acute Coronary Event Smoking Study

Completed·TThe Miriam Hospital·N/A·NCT01964898·65 enrolled

Smokers10 trials

Very Low-Nicotine Cigarettes in Smokers With SUD

Completed·—·Phase 2·NCT01989507·250 enrolled

Naltrexone and Patch for Smokers

Completed·UUS Department of Veterans Affairs·N/A·NCT00018213

Evaluation of Moclobemide, a Reversible MAO-A Inhibitor, as an Adjunct to Nicotine Replacement Therapy in Female Smokers

Completed·JJed E. Rose·Phase 2·NCT01926626·76 enrolled

Show 7 more trials

Nicotine, Non-Smokers With and Without ADHD, and Genetics Study

Completed·—·Phase 1·NCT01819259·136 enrolled

Development of a mHealth Intervention for Ambivalent Smokers

Completed·KKaiser Permanente·Phase 1·NCT04560868·57 enrolled

Electronic Cigarettes in Daily Dependent Smokers

Completed·CCentre for Addiction and Mental Health·Phase 4·NCT02108626·43 enrolled

A Pharmacokinetic Evaluation of Two Nicotine Patches in Smokers

Completed· GSK logo

GSK·Phase 1·NCT01702519·40 enrolled

Nicotine Reinforcement and Aversion in Young Adult Light Smokers

Completed·YYale University·Phase 1·NCT01495819·34 enrolled

Telephone Counseling and the Distribution of Nicotine Patches to Smokers

Completed·UUniversity of California, San Diego·Phase 3·NCT00851357·4,200 enrolled

Individualizing Pharmacotherapy for African American Smokers

Completed·UUniversity of Kansas Medical Center·Phase 3·NCT03897439·392 enrolled

Oral7 trials

Single-dose Pharmacokinetics of Oral Nicotine Replacement Products

Completed·JJohnson & Johnson Consumer and Personal Products Worldwide·N/A·NCT01228617·40 enrolled

Behavioral Economics of Human Drug Self-Administration

Completed·NNational Center for Research Resources (NCRR)··NCT00005765

Multiple-dose Nicotine Pharmacokinetics With Three Oral Nicotine Replacement Products

Completed·MMcNeil AB·Phase 1·NCT01321931·50 enrolled

Show 4 more trials

Multiple-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product.

Completed·MMcNeil AB·N/A·NCT01084707·40 enrolled

Single-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product

Completed·MMcNeil AB·N/A·NCT01084603·45 enrolled

Pharmacokinetics With a New Oral Nicotine Replacement Product and Nicorette® Gum

Completed·MMcNeil AB·N/A·NCT01152736·19 enrolled

Oral Tolerability Of Two Nicotine Dosage Forms

Completed· GSK logo

GSK·Phase 1·NCT00682461·200 enrolled

68 more indications

Effectiveness6 trials

Nicotine Replacement Therapy (NRT) and Bupropion Mechanisms of Effectiveness in Smokers

Completed·SSouthern Illinois University Carbondale·Phase 4·NCT01048944·197 enrolled

Effectiveness of Different THR Products in Adult Population

Unknown status·FFoundation for a Smoke Free World INC·Phase 3·NCT05825924·258 enrolled

A Cost-effectiveness Study of Nicotine Patches Distributed Through a Quitline

Completed·UUniversity of Colorado, Denver·N/A·NCT01889771·1,495 enrolled

Show 3 more trials

A Comparative Effectiveness & Long Term Health Study in Wisconsin Smokers

Completed·UUniversity of Wisconsin, Madison·Phase 4·NCT01553084·1,086 enrolled

Comparing the Effectiveness of Combined NRT With Single NRT in Primary Care Clinics in Hong Kong

Completed·HHospital Authority, Hong Kong·N/A·NCT03836560·560 enrolled

Long-term Effectiveness of Mailed Nicotine Replacement Therapy: A 5-year Follow-up

Completed·CCentre for Addiction and Mental Health·N/A·NCT03097445·1,000 enrolled

Schizophrenia5 trials

5HT3 Antagonism and Auditory Gating in Schizophrenia

Completed·UUS Department of Veterans Affairs·N/A·NCT00018850

Nicotine Effects on Endophenotypes of Schizophrenia

Completed·UUniversity Hospital, Bonn·N/A·NCT01315002·121 enrolled

Effects of Transdermal Nicotine on Smoking, Craving and Withdrawal in People With Schizophrenia

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 2·NCT00218218·48 enrolled

Show 2 more trials

Effect of Nicotine Transdermal Patch on Cognitive Function and Glycolipid Metabolism in Non-smoking Schizophrenia

Unknown status·SSir Run Run Shaw Hospital·Phase 1·NCT05301660·80 enrolled

E-cigarettes to Promote Smoking Reduction Among Individuals With Schizophrenia

Completed·TThe University of Texas Health Science Center, Houston·N/A·NCT02918630·7 enrolled

Craving4 trials

Provoked Craving Relief Study by NRT

Completed· GSK logo

GSK·Phase 2·NCT01476202·120 enrolled

Nicotine Mouth Film for Craving Relief.

Completed· GSK logo

GSK·Phase 3·NCT01702532·320 enrolled

Control Systems Approach to Predicting Individualized Dynamics of Nicotine Cravings

Unknown status·SStony Brook University·N/A·NCT02643914·23 enrolled

Show 1 more trial

Provoked Craving Assessment

Completed· GSK logo

GSK·Phase 2·NCT01506908·323 enrolled

Nicotine Dependence4 trials

Group Therapy for Nicotine Dependence: Mindfulness and Smoking

Completed·MM.D. Anderson Cancer Center·N/A·NCT00297479·650 enrolled

Nicotine Dependence, Withdrawal and Replacement Therapy Assessed by PET Imaging

Completed·JJohns Hopkins University·Phase 4·NCT01664741·127 enrolled

An Effectiveness Trial of Maintenance Therapy for Nicotine Dependence

Completed·UUniversity of Pennsylvania·Phase 4·NCT01047527·525 enrolled

Show 1 more trial

Treating Nicotine Dependence in Schizophrenic Individuals: Effectiveness of Bupropion - 1

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 2·NCT00124683·59 enrolled

Attention4 trials

Smartphone-Delivered Attentional Bias Modification Training in Helping Patients Quit Smoking

Completed·MM.D. Anderson Cancer Center·N/A·NCT02224391·311 enrolled

Effects of Prazosin on the Attention-Enhancing Effects of Nicotine

Withdrawn·UUniversity of Maryland, Baltimore·N/A·NCT03416569

The Use of AVL-3288 to Potentiate the Attention-Enhancing Effects of Low-Dose Nicotine

Withdrawn·UUniversity of Maryland, Baltimore·Phase 1·NCT03281694

Show 1 more trial

Effects of Nicotine on Elements of Attentions in Smokers and Nonsmokers

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 1·NCT01034020·100 enrolled

Tobacco Cessation3 trials

Mobile Health Technology for Personalized Tobacco Cessation Support Among Cancer Survivors in Laos

Completed·UUniversity of Oklahoma·Phase 2·NCT05253573·80 enrolled

Improving the Population-Wide Effectiveness of U.S. Tobacco Cessation Quitlines

Completed·UUniversity of Wisconsin, Madison·Phase 4·NCT01087905·987 enrolled

Mobile Contingency Management for Marijuana and Tobacco Cessation

Completed·—·N/A·NCT02869451·7 enrolled

Biomarkers3 trials

Analysis of Aldehyde Biomarkers of Exposure and Host Response

Terminated·UUniversity of Nebraska·N/A·NCT00482690·35 enrolled

Validation of Biomarkers of Exposure and Host Response

Completed·UUniversity of Nebraska·N/A·NCT00468234·60 enrolled

Evoked Responses as Pharmacodynamic Biomarkers in Healthy and Schizophrenic Participants (MK-4334-007)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT05136690·38 enrolled

Parkinson's Disease3 trials

Nicotine Treatment of Impulsivity in Parkinson's Disease

Unknown status·UUniversity of Vermont·Phase 4·NCT01216904·20 enrolled

Efficacy of Transdermal Nicotine, on Motor Symptoms in Advanced Parkinson's Disease

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 2·NCT00873392·40 enrolled

Disease-modifying Potential of Transdermal NICotine in Early Parkinson's Disease

Unknown status·JJames BOYD MD·Phase 2·NCT01560754·160 enrolled

MPA2 trials

An Exploratory Study Comparing Two Nicotine Inhalers

Completed·MMcNeil AB·Phase 1·NCT01478230·36 enrolled

Comparison of Pharmacokinetic Profiles of Two Nicotine Gum Formulations

Completed· GSK logo

GSK·Phase 1·NCT01847443·84 enrolled

Lozenge2 trials

Early Effects of a New Oral Nicotine Replacement Product and NiQuitin™ Lozenge

Completed·MMcNeil AB·Phase 2·NCT01075659·200 enrolled

Pilot Pharmacokinetic Study of Investigational Sublingual Nicotine Tablet Versus COMMIT Nicotine Lozenge

Completed·PPharmaceutical Productions Inc.·Phase 1·NCT01887847·6 enrolled

Vaping2 trials

Vaping THC From Electronic Cigarettes

Completed·UUniversity of California, San Francisco·Phase 3·NCT02955329·8 enrolled

Research and Innovation to Stop E-cigarette/Vaping in Young Adults

Completed·OOhio State University·Phase 4·NCT04974580·508 enrolled

Cognition2 trials

Effects of Exercise and Nicotine on Cognition in Smokers

Completed·WWestern University, Canada·Phase 3·NCT03091699·34 enrolled

Cognition and Smoking Relapse (HCS)

Completed·UUniversity of Pennsylvania··NCT03169101·274 enrolled

Depressed2 trials

Depressed Mood Improvement Through Nicotine Dosing (Depressed MIND Study)

Completed·VVanderbilt University Medical Center·Phase 4·NCT02816138·15 enrolled

Depressed Mood Improvement Through Nicotine Dosing 2

Completed·VVanderbilt University Medical Center·Phase 2·NCT04433767·29 enrolled

Pilot Study2 trials

Pilot Study of Nicotine Nasal Spray and Varenicline on Smoking in Methadone-Maintained Patients

Terminated·UUniversity of Cincinnati·Phase 4·NCT02147132·7 enrolled

Mobile Media-Rich Interactive Guideline System (MMRIGS) Pilot Study

Terminated·MM.D. Anderson Cancer Center·N/A·NCT02302859·8 enrolled

Tobacco2 trials

Smoking Tobacco and Drinking Study

Completed·UUniversity of California, San Francisco·Phase 4·NCT03163303·179 enrolled

Combination of Nicotine Replacement Therapy (NRT) and Varenicline to Increase Cessation of Tobacco (CONVICT Study)

Completed·QQueen Mary University of London·Phase 3·NCT01184664·117 enrolled

Lung Cancer2 trials

Centralized Lung Cancer EARly Detection Among Smokers (CLEAR Study)

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT04200534·358 enrolled

Assessing the Integration of Tobacco Cessation Treatment Into Lung Cancer Screening (LCS)

Completed·MMassachusetts General Hospital·Phase 4·NCT03611881·642 enrolled

Cognitive impairment2 trials

Nicotinic Treatment of Post-Chemotherapy Subjective Cognitive Impairment: A Pilot Study

Completed·VVanderbilt University Medical Center·Phase 2·NCT02312934·22 enrolled

Nicotine Treatment of Mild Cognitive Impairment (MCI)

Unknown status·NNational Institute on Aging (NIA)·Phase 1·NCT00091468·75 enrolled

Smoking Reduction2 trials

Smoking Reduction or Cessation With Nicotine Replacement Therapy

Completed·MMcNeil AB·Phase 3·NCT00840242·314 enrolled

Smoking Reduction Intervention for Smoking Parents of Paediatric Patients in Hong Kong

Completed·—·Phase 4·NCT03879889·210 enrolled

Nicotine Withdrawal1 trial

Nicotine Withdrawal Symptoms and Smoking Relapse

Completed·NNational Institute on Drug Abuse (NIDA)·N/A·NCT01511614·112 enrolled

Tobacco Use1 trial

The Effects of Menthol as Delivered by an Electronic Cigarette on the Desirability of Nicotine in Tobacco Users

Completed·YYale University·N/A·NCT02102100·57 enrolled

Psychiatric Disorder1 trial

Varenicline for Smoking Cessation in Hospitalized Patients With Psychiatric Disorders

Withdrawn·HHospital Universitari Vall d'Hebron Research Institute·Phase 4·NCT03809897

Tobacco Use Cessation1 trial

Adapting and Evaluating a Tobacco Use Cessation Program for People Living With HIV in Uganda and Zambia

Recruiting·UUniversity of Southern California·Phase 1·NCT05487807·800 enrolled

Progesterone1 trial

Effects of Progesterone on IV Nicotine-Induced Changes in Hormones and Subjective Ratings of Stimulant Drug Effect

Withdrawn·MMclean Hospital·N/A·NCT01589081

ESS1 trial

The Avenues Study: Dual Use Cessation

Recruiting·UUniversity of Wisconsin, Madison·Phase 4·NCT06474299·500 enrolled

Acute1 trial

Pharmacokinetics and Acute Effects of Multiple Dose of Nicotine: Electronic Cigarette and Cigarette

Completed·PParc de Salut Mar·Phase 1·NCT02511704·12 enrolled

Third Molar Surgery1 trial

Nicotine as an Adjuvant Analgesic for Third Molar Surgery

Completed·—·Phase 4·NCT00385216·20 enrolled

Anxiety1 trial

Smoking Termination / Anxiety Reduction Treatment (ST/ART)

Completed·UUniversity of Houston·Phase 1·NCT01789125·74 enrolled

Acute Coronary Syndrome1 trial

The Safety of Transdermal Nicotine Immediately Following an Acute Coronary Syndrome

Suspended·SSir Mortimer B. Davis - Jewish General Hospital·N/A·NCT00990197·30 enrolled

Function1 trial

IV Nicotine Induced Changes in Hormone Function, Mood States and Behavior

Withdrawn·MMclean Hospital·N/A·NCT01589055

Vascular Function1 trial

Effect of Smoking Reduction on Endothelial Glucocalyx and Vascular Function

Unknown status·UUniversity of Athens·Phase 4·NCT02307045·600 enrolled

Opioid1 trial

Effects of Nicotine on Brain Opioid Receptors

Terminated·UUniversity of Pennsylvania··NCT01040338·15 enrolled

Recurrence1 trial

Comparison of Nicotine Inhaler and/or Bupropion in Helping People to Stop Smoking and Prevent the Recurrence of Smoking

Completed·AAlliance for Clinical Trials in Oncology·Phase 3·NCT00033592·1,708 enrolled

Non-Small Cell Lung Cancer1 trial

S0002 - A Program to Quit Smoking With or Without Bupropion in Treating Patients With Stage I or II Non-Small Cell Lung Cancer Who Have Undergone Surgery

Terminated·SSWOG Cancer Research Network·Phase 3·NCT00032084·10 enrolled

Magnetic Resonance Imaging1 trial

Functional Magnetic Resonance Imaging (fMRI) Investigation of Nicotine Withdrawal Symptoms

Completed· GSK logo

GSK·Phase 4·NCT00657020·23 enrolled

Cancer1 trial

Nicotine in Treating "Hunger Pain" in Patients With Malignant Bowel Obstruction Caused By Cancer

Withdrawn·MMayo Clinic·N/A·NCT00425906

Cervical Cancer1 trial

Enhancing Long-Term Smoking Abstinence Among Cervical Cancer Survivors (Project ACCESS)

Active, not recruiting·HH. Lee Moffitt Cancer Center and Research Institute·N/A·NCT05645146·360 enrolled

Intensive Care Unit1 trial

Nicotine Replacement Therapy in the Intensive Care Unit

Completed·—·Phase 4·NCT01362959·47 enrolled

Analgesic1 trial

Nicotine Patch as an Analgesic Adjuvant After Surgery

Completed·—·Phase 4·NCT00440830·68 enrolled

Randomized Controlled Trial1 trial

A Pilot Randomized Controlled Trial of Financial Incentives, Text Messaging, and Usual Care for Homeless Smokers

Completed·MMassachusetts General Hospital·N/A·NCT02565381·83 enrolled

Postoperative Pain Relief1 trial

Preemptive Use of the Nicotine Patch for Postoperative Pain Relief After Open Abdominal Surgery

Terminated·SStony Brook University·N/A·NCT00790829·30 enrolled

Peripheral Neuropathy1 trial

Study of Nicotine for Pain Associated With Chemotherapy-Induced Peripheral Neuropathy

Terminated·VVirginia Commonwealth University·Phase 2·NCT04468230·4 enrolled

Irritation1 trial

Cumulative Skin Irritation Potential of a New 25 mg Nicotine Patch

Completed·MMcNeil AB·Phase 1·NCT00967174·42 enrolled

Wound Healing1 trial

Effect of Smoking, Abstention and Nicotine Replacement Therapy on Wound Healing

Completed·—·N/A·NCT00825851·78 enrolled

Efficacy and Safety1 trial

Study to Determine the Efficacy and Safety of a Novel Nicotine Replacement Therapy

Completed·MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.·Phase 3·NCT02355665·1,198 enrolled

Tobacco Dependence1 trial

Safety, Tolerability and Efficacy of the Nicotine Patch and Gum for the Treatment of Adolescent Tobacco Dependence

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 2/3·NCT01208935·157 enrolled

Bariatric Surgery1 trial

Nicotine Administration and Post-operative Opioid Use With Bariatric Surgery

Completed·TToby Weingarten·Phase 4·NCT01194089·95 enrolled

Critically Ill Patients1 trial

Prevention of Nicotine Abstinence in Critically Ill Patients After Major Surgery

Completed·UUniversity Hospital Ostrava·N/A·NCT03847155·52 enrolled

Relapse1 trial

Strengthening Instrumental Extinction to Prevent Smoking Relapse (VLNCCue)

Completed·FFrancis McClernon, Ph.D.·N/A·NCT02538042·87 enrolled

Imaging1 trial

PET Imaging Using the Tracer [18F]VAT to Assess the Antidepressant Effect of Nicotine.

Recruiting·SStony Brook University·Phase 4·NCT07095205·14 enrolled

Thoracic Surgery1 trial

Effect of Perioperative High-dose Transdermal Nicotine Patch on Pain Sensitivity Among Male Abstinent Tobacco Smokers Undergoing Thoracic Surgery: A Randomized Controlled Pilot Study

Recruiting·HHenan Provincial People's Hospital·N/A·NCT07250230·80 enrolled

Oxidative Stress1 trial

Nicotine Patch, Blood Flow and Oxidative Stress Study

Completed·UUniversity of Pennsylvania·N/A·NCT00954096·55 enrolled

Skin1 trial

Skin Sensitization Potential of a New Nicotine Patch

Completed·MMcNeil AB·Phase 1·NCT00967070·257 enrolled

Physical Activity1 trial

Increasing Physical Activity as Part of a Smoking Cessation Program

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·N/A·NCT00403312·400 enrolled

Trial1 trial

QuitAid Pilot Feasibility Trial

Completed·UUniversity of Virginia·N/A·NCT05649241·24 enrolled

Chronic Obstructive Pulmonary Disease1 trial

Nurse Smoking Cessation of Patients With Chronic Obstructive Pulmonary Disease (COPD) With Nicotine Replacement Therapy (NRT) and Behavioral Support

Terminated·UUniversity Hospital, Gentofte, Copenhagen·Phase 3·NCT00132236·300 enrolled

Hand-foot syndrome1 trial

Nicotine Patches in Reducing Hand-Foot Syndrome in Patients Who Are Receiving Capecitabine For Metastatic Breast Cancer

Terminated·UUniversity of California, San Francisco·Phase 2·NCT00751101·24 enrolled

Virtual Reality1 trial

Nicotine Virtual Reality Conditioned Place Preference

Withdrawn·UUniversity of Chicago·Phase 4·NCT06259630

Addiction1 trial

Do Flavors Increase the Addiction Potential of Nicotine?

Completed·UUniversity of Vermont·Phase 2·NCT04696380·19 enrolled

Schizoaffective Disorder1 trial

Nicotine Patch for Nicotine Dependence in Individuals With Schizophrenia or Schizoaffective Disorder - 1

Terminated·NNational Institute on Drug Abuse (NIDA)·Phase 4·NCT00046813·100 enrolled

Smoking Behavior1 trial

Effects of Menthol in E-cigarettes on Smoking Behaviors

Completed·YYale University·Phase 1·NCT04521647·10 enrolled

Adult1 trial

Nicotine and Behavior in Adult ADHD

Completed·UUniversity of California, Irvine·N/A·NCT00573248·78 enrolled

Mental Illness1 trial

Treating Smokers With Mental Illness

Completed·UUniversity of Minnesota·Phase 2·NCT03822416·38 enrolled

AIN1 trial

Brain Nicotine Receptor Density & Response to Nicotine Patch

Completed·—··NCT01526005·50 enrolled

Vomiting1 trial

Transdermal Nicotine in Female Patients at High Risk for Post Operative Nausea and/or Vomiting (PONV)

Withdrawn·OOchsner Health System·N/A·NCT00775749

Sarcoidosis1 trial

Study of Nicotine Patches in Patients With Sarcoidosis

Completed·—·Phase 1·NCT00701207·64 enrolled

Autism1 trial

Nicotinic Cholinergic Modulation as a Novel Treatment Strategy for Aggression Associated With Autism

Completed·YYale University·Phase 1·NCT02552147·8 enrolled

Adolescent1 trial

Nicotine Replacement and Counseling In Adolescents

Completed·UUniversity of California, San Francisco·Phase 4·NCT00625794·40 enrolled

Unspecified13 trials

E-cigarette Nicotine Study

Completed·UUniversity of Vermont·Phase 2·NCT04709471·77 enrolled

Bioequivalence Between Nicotine Replacement Products and Nicorette® Gum

Completed·MMcNeil AB·N/A·NCT01113424·88 enrolled

Effects of E-cigarette Flavors on Youth TCORS 2.0

Completed·YYale University·Phase 1·NCT03634839·42 enrolled

Show 10 more trials

Nicotine Patch - Multidose Bioequivalence Study

Completed·PPierre Fabre Medicament·Phase 1·NCT01658215·43 enrolled

Nicotine Patch Safety Study

Completed·PPierre Fabre Medicament·Phase 2·NCT01655082·160 enrolled

Personalized Dosing of Nicotine Replacement (NRT to Effect)

Completed·CCentre for Addiction and Mental Health·Phase 4·NCT03000387·211 enrolled

Nicotine Replacement Therapy in Nicotine-dependent Arrestees

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 4·NCT02905734·800 enrolled

Clinical Study of Smoke-Break Liquid Cigarettes

Completed·SSmoke-Break, Inc.·Phase 2·NCT00715871·52 enrolled

Nicotinic Modulation of the Default Network

Completed·UUniversity of Maryland, Baltimore·N/A·NCT01223404·21 enrolled

Targeting Mailed Nicotine Patch Distribution Interventions to Rural Regions of Canada

Completed·CCentre for Addiction and Mental Health·Phase 4·NCT04606797·498 enrolled

Addictive Threshold of Nicotine

Recruiting·YYale University·Phase 1·NCT06096714·36 enrolled

Nicotine and Pavlovian Bias

Unknown status·UUniversity of Southern California·Phase 1·NCT06027723·40 enrolled

4 mg Nicotine Polacrilex Gum and Swedish Portion Snus

Completed·CContract Research Organization el AB·Phase 1/2·NCT01182129·15 enrolled

Regulatory

FDA Approval Timeline[5]

Mar 22, 1996

NICOTROL

NDA NDA020385

Jul 3, 1996

NICOTROL

NDA NDA020536

Aug 2, 1996

NICODERM CQ

NDA NDA020165

May 2, 1997

NICOTROL

NDA NDA020714

Dec 23, 1998

PROSTEP

NDA NDA019983

Nov 12, 1999

HABITROL

NDA NDA020076

Sources

References

[1]
ClinicalTrials.gov — 302 trial records for Nicotine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Nicorette drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Nicotine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Nicotine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA020076). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Pfizer company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Neuronal Acetylcholine Receptor; Alpha4/beta2 Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Pfizer