Nicotine

also known as Nicotine polacrilex · Nicoderm CQ · Nicotine patch · Habitrol · Nicorette · Nicotrol · Aveva · Commit · +18 more

Developed for: nicotine dependence · schizophrenia · alcohol dependence · cannabis dependence · depressive disorder · schizoaffective disorder · major depressive disorder · Parkinson disease
+22 more
· substance withdrawal syndrome · COVID-19 · alcohol-related disorders · chemotherapy-induced toxicity · cognitive impairment with or without cerebellar ataxia · coronary artery disorder · attention deficit-hyperactivity disorder · chemotherapy-induced neuropathy · cognitive disorder · Down syndrome · hand-foot syndrome · impulse control disorder · pelvis syndrome · pulmonary sarcoidosis · sarcoma · schizophreniform disorder · smooth surface dental caries · tinnitus · ulcer of lower limbs · acquired aneurysmal subarachnoid hemorrhage · ileus · sleep disorder
Investigated by: National Institute on Drug Abuse (NIDA) · National Cancer Institute (NCI) · Yale University · McNeil AB · University of Wisconsin, Madison · Johns Hopkins University
+235 more
· GlaxoSmithKline · Centre for Addiction and Mental Health · National Institutes of Health (NIH) · Vanderbilt University Medical Center · Assistance Publique - Hôpitaux de Paris · Duke University · M.D. Anderson Cancer Center · University of California, San Francisco · National Institute on Alcohol Abuse and Alcoholism (NIAAA) · Ohio State University Comprehensive Cancer Center · University of Vermont · Massachusetts General Hospital · Medical University of South Carolina · US Department of Veterans Affairs · University of Pennsylvania · Brown University · Ottawa Heart Institute Research Corporation · The University of Hong Kong · University of Maryland, Baltimore · Columbia University · Heart and Stroke Foundation of Ontario · Mayo Clinic · Milton S. Hershey Medical Center · National Institute of Mental Health (NIMH) · Pfizer · University of Oklahoma · University of Virginia · Wake Forest University Health Sciences · Canadian Cancer Society (CCS) · Dean Health System · Mclean Hospital · Mercy Health System · National Heart, Lung, and Blood Institute (NHLBI) · National Institute on Aging (NIA) · North Suffolk Mental Health Association · Patient-Centered Outcomes Research Institute · Stony Brook University · UConn Health · University of California, Los Angeles · University of Minnesota · University of Southern California · Virginia Commonwealth University · 22nd Century Limited, LLC · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Evotec Neurosciences GmbH · Food and Drug Administration (FDA) · George Washington University · Hennepin Healthcare Research Institute · Kaiser Permanente · Maryland Cigarette Restitution Fund · Masonic Cancer Center, University of Minnesota · McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. · New York University · Northwestern University · Ontario Ministry of Health and Long Term Care · Philip Morris USA · Queen Mary University of London · Roswell Park Cancer Institute · Rutgers, The State University of New Jersey · Stanford University · The University of Texas Health Science Center, Houston · University College, London · University of California, San Diego · University of Cincinnati · University of Florida · University of Illinois at Chicago · University of Kansas Medical Center · University of Miami · University of North Carolina, Chapel Hill · University of Oulu · University of Tennessee · Vince & Associates Clinical Research, Inc. · Abramson Cancer Center at Penn Medicine · Academy of Finland · all 241 on the full record

Regulatory milestones approvals, filings & regulatory actions · 7 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Label expansions (4)	US (FDA)	NICORETTE	—	1996-02-09 – 2012-05-23	fda.gov ↗
Label expansion	US (FDA)	HABITROL	—	1999-11-12	fda.gov ↗
Label expansion	US (FDA)	NICODERM CQ	—	1996-08-02	fda.gov ↗
Approved	US (FDA)	NICORETTE	—	1984-01-13	fda.gov ↗

Trials 329 · started per year

today

US approved 1984

198319841985198619871988198919901991199219931994199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027202820292030

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 022 trials · 1 met primary
Phase 0	NCT06334016	Oct 2026 → Mar 2028 expected	cannabis dependence	Roswell Park Cancer Institute	Not yet recruiting	No outcome recorded
Phase 0	NCT05665465	Jan 2024 → May 2027 expected	nicotine dependence	Duke University	Recruiting	No outcome recorded
Phase 0	NCT06066996	Nov 2023 → Jun 2028 expected	substance withdrawal syndrome	Johns Hopkins University	Recruiting	No outcome recorded
Phase 0	NCT06027723	Oct 2023 → Aug 2024	nicotine dependence	University of Southern California	Unknown	No outcome recorded
Phase 0	NCT05758298	Oct 2023 → Dec 2024	—	University of Texas Southwestern Medical Center	Withdrawn	No outcome recorded
Phase 0	NCT05484505	Jul 2023 → Dec 2024	—	Nazarbayev University	Unknown	No outcome recorded
Phase 0	NCT05018117	Jun 2022 → Dec 2025	—	University of California, Berkeley	Unknown	No outcome recorded
Phase 0	NCT05301660	Mar 2022 → Feb 2023	schizophrenia	Sir Run Run Shaw Hospital	Unknown	No outcome recorded
Phase 0	NCT05236894	Mar 2022 → Apr 2023	—	Ohio State University Comprehensive Cancer Center	Completed	No outcome recorded
Phase 0	NCT05157672	Dec 2021 → Aug 2023	—	Washington State University	Unknown	No outcome recorded
Phase 0	NCT04740008	Apr 2021 → Aug 2022	—	Masonic Cancer Center, University of Minnesota	Completed	No outcome recorded
Phase 0	NCT04200534	Jul 2020 → Feb 2027 expected	lung cancer	M.D. Anderson Cancer Center	Active not recruiting	No outcome recorded
Phase 0	NCT04488744	Nov 2019 → Apr 2021	—	Yale University	Completed	No outcome recorded
Phase 0	NCT05060965	Oct 2019 → Apr 2023	nicotine dependence	Johns Hopkins University	Withdrawn	No outcome recorded Stop: Enrollment
Phase 0	NCT03580525	Feb 2019 → Nov 2020	nicotine dependence	Yale University	Completed	No outcome recorded
Phase 0	NCT02942212	Dec 2018	—	M.D. Anderson Cancer Center	Withdrawn	No outcome recorded Stop: Enrollment
Phase 0	NCT03059940	Jun 2017 → Jun 2026 overdue	—	M.D. Anderson Cancer Center	Active not recruiting	Met primary
Phase 0	NCT03134339	Jan 2017 → Jan 2018	nicotine dependence	Yale University	Completed	No outcome recorded
Phase 0	NCT01434342	Oct 2011 → Jun 2014	breast cancer, colorectal cancer, lung cancer, nicotine dependence +1	Wake Forest University Health Sciences	Completed	No outcome recorded
Phase 0	NCT01329614	Oct 2009 → Jul 2013	nicotine dependence	Columbia University	Completed	No outcome recorded
Phase 0	NCT00701207	Jul 2008 → Dec 2010	pulmonary sarcoidosis	Elliott Crouser MD	Completed	No outcome recorded
Phase 0	NCT00616746	Jan 2007 → Jun 2010	alcohol-related disorders, nicotine dependence	Yale University	Completed	No outcome recorded

Phase 137 trials · 1 met primary · 1 missed
Phase 1	NCT07585006	May → Dec 2026 expected	cancer, substance dependence	Ohio State University Comprehensive Cancer Center	Recruiting	No outcome recorded
Phase 1	NCT07476144	Jan → Apr 2026 overdue	—	JT International SA	Recruiting	No outcome recorded
Phase 1	NCT07128329	Nov 2025 → Apr 2027 expected	nicotine dependence	Johns Hopkins University	Recruiting	No outcome recorded
Phase 1	NCT06609109	Mar 2025 → Apr 2029 expected	cannabis dependence, nicotine dependence	Johns Hopkins University	Recruiting	No outcome recorded
Phase 1	NCT05136690	Apr → Sep 2022	schizophrenia	Merck Sharp & Dohme LLC	Completed	No outcome recorded
Phase 1	NCT04262817	Nov 2020 → Jan 2022	nicotine dependence	Yale University	Completed	Mixed
Phase 1	NCT04124432	Sep 2020 → Jul 2023	cannabis dependence, nicotine dependence	Johns Hopkins University	Completed	No outcome recorded
Phase 1	NCT03635333	May 2019 → Jul 2023	nicotine dependence	Yale University	Completed	No outcome recorded
Phase 1	NCT03651869	Feb 2019 → Mar 2023	nicotine dependence	University of Southern California	Completed	No outcome recorded
Phase 1	NCT03652740	Oct 2018 → Feb 2024	—	Johns Hopkins University	Completed	No outcome recorded
Phase 1	NCT03442413	Jun 2018 → Nov 2026 expected	nicotine dependence	University of Pennsylvania	Active not recruiting	No outcome recorded
Phase 1	NCT03559725	May → Oct 2018	nicotine dependence	22nd Century Limited, LLC	Completed	No outcome recorded
Phase 1	NCT03281694	May 2018 → Feb 2019	—	University of Maryland, Baltimore	Withdrawn	No outcome recorded
Phase 1	NCT03559751	Apr → Sep 2018	nicotine dependence	22nd Century Limited, LLC	Completed	No outcome recorded
Phase 1	NCT03398876	Dec 2017 → Apr 2018	—	Janssen Pharmaceutical K.K.	Completed	No outcome recorded
Phase 1	NCT02906995	May → Nov 2017	nicotine dependence	Friends Research Institute, Inc.	Completed	No outcome recorded
Phase 1	NCT03168191	May 2017 → Aug 2018	nicotine dependence	Yale University	Completed	No outcome recorded
Phase 1	NCT03408574	Oct 2016 → Dec 2021	—	University of Vermont	Completed	No outcome recorded
Phase 1	NCT02552147	Sep 2015 → Nov 2017	autism spectrum disorder	Yale University	Completed	Missed primary
Phase 1	NCT02346539	Feb 2015 → Nov 2017	depressive disorder	Mclean Hospital	Completed	No outcome recorded
Phase 1	NCT02266784	Oct 2014 → Dec 2017	—	Duke University	Completed	No outcome recorded
Phase 1	NCT02081144	May → Oct 2014	nicotine dependence	Yale University	Completed	No outcome recorded
Phase 1	NCT01847443	May → Jun 2013	—	GlaxoSmithKline	Completed	Met primary
Phase 1	NCT01359709	Jun 2011 → Jan 2016	—	University of California, Los Angeles	Completed	No outcome recorded
Phase 1	NCT01417429	Mar 2010 → Mar 2011	substance withdrawal syndrome	Yale University	Completed	No outcome recorded
Phase 1	NCT01136642	Jan 2010 → Nov 2012	nicotine dependence	National Institute on Drug Abuse (NIDA)	Completed	No outcome recorded
Phase 1	NCT01056926	Mar 2009 → Nov 2011	—	Duke University	Completed	No outcome recorded
Phase 1	NCT00833404	Dec 2008 → Jan 2010	—	University of Texas at Austin	Completed	No outcome recorded
Phase 1	NCT00618631	Jan 2008 → Jan 2015	substance-related disorder	National Institute on Drug Abuse (NIDA)	Completed	No outcome recorded
Phase 1	NCT00682461	Sep 2007 → Jan 2009	—	GlaxoSmithKline	Completed	No outcome recorded
Phase 1	NCT00527020	Aug 2007 → Jul 2008	schizophrenia	GlaxoSmithKline	Completed	No outcome recorded
Phase 1	NCT01034020	Feb 2006 → Nov 2009	nicotine dependence	National Institute on Drug Abuse (NIDA)	Completed	No outcome recorded
Phase 1	NCT00965913	May 2005	—	McNeil AB	Completed	No outcome recorded
Phase 1	NCT00967070	May → Aug 2005	—	McNeil AB	Completed	No outcome recorded
Phase 1	NCT00967174	May → Jun 2005	—	McNeil AB	Completed	No outcome recorded
Phase 1	NCT00091468	Sep 2003 → Jul 2008	cognitive disorder	National Institute on Aging (NIA)	Unknown	No outcome recorded
Phase 1	NCT00258479	Jun 2003 → Dec 2011	nicotine dependence	Catherine Martin, MD	Completed	No outcome recorded

Phase 1/28 trials · 1 missed
Phase 1/2	NCT07772089	Mar → Aug 2026	tinnitus	San Diego State University	Completed	No outcome recorded
Phase 1/2	NCT05513872	Mar 2023 → Aug 2027 expected	nicotine dependence	Rush University Medical Center	Recruiting	No outcome recorded
Phase 1/2	NCT03674970	Mar → Nov 2019	nicotine dependence	Milton S. Hershey Medical Center	Completed	Missed primary
Phase 1/2	NCT02596711	Nov 2015 → Aug 2017	nicotine dependence	M.D. Anderson Cancer Center	Completed	No outcome recorded
Phase 1/2	NCT01778946	Apr 2013 → Feb 2021	Down syndrome, cognitive impairment with or without cerebellar ataxia	Vanderbilt University Medical Center	Completed	No outcome recorded
Phase 1/2	NCT01838460	May → Aug 2012	—	Contract Research Organization el AB	Completed	No outcome recorded
Phase 1/2	NCT00957918	Oct 2009 → Sep 2010	Parkinson disease	Neuraltus Pharmaceuticals, Inc.	Completed	No outcome recorded
Phase 1/2	NCT00316537	Oct 2006 → Jul 2007	ulcer of lower limbs	CoMentis	Terminated	No outcome recorded Stop: Business
Phase 244 trials · 1 met primary · 7 missed
Phase 2	NCT07099638	May 2026 → Jun 2029 expected	—	University of Oklahoma	Not yet recruiting	No outcome recorded
Phase 2	NCT05999383	Jul 2025 → Feb 2028 expected	—	University of California, San Francisco	Recruiting	No outcome recorded
Phase 2	NCT05627596	Jun 2023 → May 2025 overdue	—	Hennepin Healthcare Research Institute	Enrolling by invitation	No outcome recorded
Phase 2	NCT05746273	Apr 2023 → Jul 2026 overdue	depressive disorder	Vanderbilt University Medical Center	Active not recruiting	No outcome recorded
Phase 2	NCT05746546	Apr 2023 → Oct 2026 expected	depressive disorder	Vanderbilt University Medical Center	Active not recruiting	No outcome recorded
Phase 2	NCT04038515	Oct 2022 → Jun 2024	nicotine dependence	Yale University	Completed	No outcome recorded
Phase 2	NCT04946825	Jun 2021 → Aug 2023	nicotine dependence	University of Vermont	Completed	No outcome recorded
Phase 2	NCT04696380	Mar → Aug 2021	nicotine dependence	University of Vermont	Completed	No outcome recorded
Phase 2	NCT04709471	Jan 2021 → Apr 2022	nicotine dependence	University of Vermont	Completed	No outcome recorded
Phase 2	NCT04634071	Jan 2021 → Jan 2026	cancer-related condition	Joseph Valentino, MD	Completed	No outcome recorded
Phase 2	NCT04433767	Dec 2020 → Oct 2022	depressive disorder	Vanderbilt University Medical Center	Completed	No outcome recorded
Phase 2	NCT04468230	Jul 2020 → May 2022	chemotherapy-induced neuropathy, neuropathy, painful	Virginia Commonwealth University	Terminated	No outcome recorded Stop: Enrollment
Phase 2	NCT03865121	Mar → Nov 2019	Parkinson disease	El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez	Completed	Missed primary
Phase 2	NCT03822416	Mar 2019 → May 2020	bipolar I disorder, bipolar II disorder, major depressive disorder, schizophrenia	University of Minnesota	Completed	No outcome recorded
Phase 2	NCT02487953	Jul 2018 → Jan 2020	nicotine dependence	Duke University	Withdrawn	No outcome recorded
Phase 2	NCT03316170	Nov 2017 → Mar 2020	—	Jessica Burris	Completed	Missed primary
Phase 2	NCT02501265	Jun 2017 → Jul 2020	nicotine dependence	Duke University	Completed	Met primary
Phase 2	NCT02720445	Feb 2017 → Aug 2025	cognitive impairment with or without cerebellar ataxia	University of Southern California	Completed	No outcome recorded
Phase 2	NCT02312934	Aug 2015 → May 2018	breast cancer, chemotherapy-induced toxicity	Vanderbilt University Medical Center	Completed	Missed primary
Phase 2	NCT01989507	Apr 2014 → May 2021	nicotine dependence	Brown University	Completed	No outcome recorded
Phase 2	NCT01857531	Jun → Jul 2013	—	Jed E. Rose	Completed	No outcome recorded
Phase 2	NCT01560754	Oct 2012 → Aug 2016	Parkinson disease	James BOYD MD	Unknown	Missed primary
Phase 2	NCT01669122	Jun → Aug 2012	—	GlaxoSmithKline	Completed	No outcome recorded
Phase 2	NCT01476202	Nov 2011 → Jan 2012	—	GlaxoSmithKline	Completed	No outcome recorded
Phase 2	NCT00956943	Aug 2009 → Aug 2011	nicotine dependence	University of Pennsylvania	Completed	No outcome recorded
Phase 2	NCT01292642	Aug 2009 → Jun 2011	cannabis dependence, nicotine dependence	Mclean Hospital	Completed	No outcome recorded
Phase 2	NCT00960778	Mar 2009 → Jun 2012	nicotine dependence	Medical University of South Carolina	Completed	No outcome recorded
Phase 2	NCT00873392	Feb 2009 → Dec 2012	Parkinson disease	Assistance Publique - Hôpitaux de Paris	Completed	No outcome recorded
Phase 2	NCT00738595	Aug 2008 → Mar 2009	—	Evotec Neurosciences GmbH	Completed	No outcome recorded
Phase 2	NCT00622752	Feb → May 2008	—	Evotec Neurosciences GmbH	Completed	No outcome recorded
Phase 2	NCT00715871	Feb → Jul 2008	—	Smoke-Break, Inc.	Completed	No outcome recorded
Phase 2	NCT00553709	Oct 2007 → Aug 2009	—	University Hospital, Geneva	Terminated	No outcome recorded Stop: Enrollment
Phase 2	NCT00751101	Aug 2007 → Mar 2014	breast cancer, chemotherapy-induced toxicity, hand-foot syndrome	University of California, San Francisco	Terminated	No outcome recorded Stop: Enrollment
Phase 2	NCT00350311	Feb 2007 → Apr 2008	obesity disorder, psychotic disorder	The University of New South Wales	Completed	No outcome recorded
Phase 2	NCT01085032	Aug 2006 → Jul 2009	—	University of Memphis	Completed	Missed primary
Phase 2	NCT00295984	Mar → Aug 2006	sarcoma	National Cancer Institute (NCI)	Completed	No outcome recorded
Phase 2	NCT00699556	Jan 2006 → Nov 2016	alcohol-related disorders	Yale University	Completed	No outcome recorded
Phase 2	NCT00297492	Jan 2006 → Feb 2008	—	University of Vermont	Completed	Missed primary
Phase 2	NCT00218283	Jan 2005 → Jun 2007	nicotine dependence	National Institute on Drug Abuse (NIDA)	Completed	No outcome recorded
Phase 2	NCT00115687	Jun 2002 → Apr 2007	nicotine dependence	National Institute on Drug Abuse (NIDA)	Terminated	Missed primary
Phase 2	NCT00218218	Jun 2002 → Feb 2005	nicotine dependence, schizophrenia	National Institute on Drug Abuse (NIDA)	Completed	No outcome recorded
Phase 2	NCT00158171	Apr 2002 → May 2004	nicotine dependence	National Institute on Drug Abuse (NIDA)	Completed	No outcome recorded
Phase 2	NCT00018161	Jan 1997 → Jun 2001	—	US Department of Veterans Affairs	Completed	No outcome recorded
Phase 2	NCT00218140	? → Apr 2005	nicotine dependence	National Institute on Drug Abuse (NIDA)	Completed	No outcome recorded

Phase 2/36 trials · 1 met primary
Phase 2/3	NCT04994444	Sep 2021 → Apr 2024	nicotine dependence	Brown University	Completed	No outcome recorded
Phase 2/3	NCT04501016	Sep 2020 → Aug 2021 overdue	nicotine dependence	Iowa City Veterans Affairs Medical Center	Not yet recruiting	No outcome recorded
Phase 2/3	NCT03521141	May 2018 → Apr 2019	nicotine dependence	Vanderbilt University Medical Center	Completed	No outcome recorded
Phase 2/3	NCT01531049	May 2012 → Dec 2015	—	Tuula Toljamo	Completed	No outcome recorded
Phase 2/3	NCT00459953	Sep 2006 → Jun 2011	nicotine dependence	Stanford University	Completed	Met primary
Phase 2/3	NCT01208935	Aug 1999 → Jun 2004	nicotine dependence	National Institute on Drug Abuse (NIDA)	Completed	No outcome recorded
Phase 329 trials · 4 met primary · 5 missed
Phase 3	NCT06811038	Oct 2026 → Jul 2029 expected	—	Fred Hutchinson Cancer Center	Not yet recruiting	No outcome recorded
Phase 3	NCT06832098	Mar 2025 → Apr 2027 expected	—	University of Auckland, New Zealand	Recruiting	No outcome recorded
Phase 3	NCT05257629	Feb 2023 → Mar 2026 overdue	acute coronary syndrome	Sir Mortimer B. Davis - Jewish General Hospital	Recruiting	No outcome recorded
Phase 3	NCT04608201	Dec 2020 → Nov 2021	COVID-19	Assistance Publique - Hôpitaux de Paris	Completed	No outcome recorded
Phase 3	NCT04598594	Nov 2020 → Apr 2021	COVID-19	Assistance Publique - Hôpitaux de Paris	Completed	Missed primary
Phase 3	NCT04583410	Oct 2020 → Dec 2021	COVID-19	Assistance Publique - Hôpitaux de Paris	Unknown	No outcome recorded
Phase 3	NCT04176172	Feb 2020 → Nov 2026 expected	HIV infectious disease, nicotine dependence	Abramson Cancer Center at Penn Medicine	Active not recruiting	No outcome recorded
Phase 3	NCT02955329	Mar → Nov 2019	cannabis dependence	University of California, San Francisco	Completed	No outcome recorded
Phase 3	NCT03630614	Oct 2018 → Feb 2029 expected	—	Assistance Publique - Hôpitaux de Paris	Active not recruiting	No outcome recorded
Phase 3	NCT02896400	Feb 2017 → Aug 2019	nicotine dependence	Yale University	Completed	Mixed
Phase 3	NCT02355665	Jan → Sep 2015	nicotine dependence	McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.	Completed	Met primary
Phase 3	NCT02148445	May 2014 → Dec 2016	chronic obstructive pulmonary disease, nicotine dependence	University of Kansas Medical Center	Completed	Missed primary
Phase 3	NCT01702532	Sep → Dec 2012	—	GlaxoSmithKline	Completed	Met primary
Phase 3	NCT01184664	Apr → Oct 2011	nicotine dependence	Queen Mary University of London	Completed	Missed primary
Phase 3	NCT01296698	Mar → Apr 2011	nicotine dependence	McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.	Terminated	No outcome recorded
Phase 3	NCT01287377	Nov 2010 → May 2011	—	University of California, San Diego	Completed	No outcome recorded
Phase 3	NCT00985985	May 2009 → Mar 2011	—	GlaxoSmithKline	Completed	Missed primary
Phase 3	NCT00744913	Aug 2008 → Feb 2010	—	The Hospital for Sick Children	Withdrawn	No outcome recorded Stop: Enrollment
Phase 3	NCT00507975	Nov 2007 → Nov 2012	—	Assistance Publique - Hôpitaux de Paris	Completed	Missed primary
Phase 3	NCT00734617	Aug 2007 → May 2009	—	Duke University	Completed	No outcome recorded
Phase 3	NCT00392379	Jan 2007 → Mar 2009	—	Mayo Clinic	Completed	Met primary
Phase 3	NCT00364156	Jun 2004 → Apr 2008	nicotine dependence	University of Pennsylvania	Completed	Mixed
Phase 3	NCT00108537	Oct 2003 → Sep 2005	nicotine dependence	US Department of Veterans Affairs	Completed	No outcome recorded
Phase 3	NCT00067158	Apr 2003 → Jul 2004	nicotine dependence	New York University	Completed	No outcome recorded
Phase 3	NCT00033592	Feb 2002 → Jul 2006	lung cancer	Alliance for Clinical Trials in Oncology	Completed	No outcome recorded
Phase 3	NCT00132236	Feb 2002 → Jun 2004	chronic obstructive pulmonary disease	University Hospital, Gentofte, Copenhagen	Terminated	No outcome recorded
Phase 3	NCT00086385	Sep 2001 → Mar 2009	nicotine dependence	University of California, San Francisco	Completed	Met primary
Phase 3	NCT00366977	Jun 2000 → Jan 2005	nicotine dependence	Kaiser Permanente	Completed	No outcome recorded
Phase 3	NCT00840242	Feb 1999 → May 2000	—	McNeil AB	Completed	No outcome recorded

Phase 484 trials · 8 met primary · 15 missed
Phase 4	NCT07835555	Sep 2027 → Sep 2030 expected	HIV infectious disease, nicotine dependence	Yale University	Not yet recruiting	No outcome recorded
Phase 4	NCT07809854	Apr 2027 → Apr 2030 expected	—	VA Office of Research and Development	Not yet recruiting	No outcome recorded
Phase 4	NCT07503925	Jul 2026 → Dec 2027 expected	cancer	Ohio State University Comprehensive Cancer Center	Not yet recruiting	No outcome recorded
Phase 4	NCT07419425	Jul 2026 → Jan 2030 expected	—	University of Wisconsin, Madison	Recruiting	No outcome recorded
Phase 4	NCT07220356	Dec 2025 → Jun 2026 overdue	nicotine dependence	Johns Hopkins University	Active not recruiting	No outcome recorded
Phase 4	NCT07148232	Nov 2025 → Jun 2027 expected	nicotine dependence	University of California, San Francisco	Recruiting	No outcome recorded
Phase 4	NCT05587361	Nov 2024 → Mar 2027 expected	nicotine dependence	University of Oklahoma	Recruiting	No outcome recorded
Phase 4	NCT06545669	Oct 2024 → Oct 2025	nicotine dependence	Johns Hopkins University	Completed	No outcome recorded
Phase 4	NCT06598397	Oct 2024 → Jun 2028 expected	HIV infectious disease	New York University	Recruiting	No outcome recorded
Phase 4	NCT07095205	Oct 2024 → Sep 2029 expected	major depressive disorder	Stony Brook University	Recruiting	No outcome recorded
Phase 4	NCT06350175	Aug 2024 → Mar 2025	nicotine dependence	West Virginia University	Withdrawn	No outcome recorded
Phase 4	NCT06098144	Apr 2024 → Feb 2027 expected	nicotine dependence	University of Miami	Recruiting	No outcome recorded
Phase 4	NCT06051474	Mar 2024 → Apr 2025	—	University of Wisconsin, Madison	Completed	No outcome recorded
Phase 4	NCT05683821	Jul 2023 → May 2025	—	University of Wisconsin, Madison	Completed	No outcome recorded
Phase 4	NCT05351606	May 2023 → Jan 2025	nicotine dependence	University of California, San Francisco	Completed	No outcome recorded
Phase 4	NCT05515354	Nov 2022 → Apr 2026 overdue	nicotine dependence	Centre for Addiction and Mental Health	Recruiting	No outcome recorded
Phase 4	NCT04974580	Jul 2021 → Dec 2022	nicotine dependence	Ohio State University	Completed	Missed primary
Phase 4	NCT03857139	Dec 2020 → Jan 2022	nicotine dependence, opioid abuse	University of Houston	Withdrawn	No outcome recorded Stop: Business
Phase 4	NCT04606797	Nov 2020 → Feb 2022	nicotine dependence	Centre for Addiction and Mental Health	Completed	No outcome recorded
Phase 4	NCT04604509	Aug 2020 → Dec 2028 expected	—	M.D. Anderson Cancer Center	Recruiting	No outcome recorded
Phase 4	NCT04490057	Jul 2020 → Oct 2024	nicotine dependence	Yale University	Completed	Missed primary
Phase 4	NCT04199117	Mar 2020 → Oct 2024	—	University of Wisconsin, Madison	Completed	No outcome recorded
Phase 4	NCT04020718	Jan → Nov 2020	nicotine dependence	Massachusetts General Hospital	Completed	No outcome recorded
Phase 4	NCT03611881	Apr 2019 → Jan 2024	nicotine dependence	Massachusetts General Hospital	Completed	Met primary
Phase 4	NCT03235505	Aug 2018 → Mar 2021	—	University of Oulu	Completed	Met primary
Phase 4	NCT03538938	Jun 2018 → Aug 2023	nicotine dependence	University of Wisconsin, Madison	Completed	Missed primary
Phase 4	NCT03491059	Feb 2018 → Dec 2024	—	University of Cincinnati	Unknown	No outcome recorded
Phase 4	NCT03000387	Jan 2018 → Feb 2023	nicotine dependence	Centre for Addiction and Mental Health	Completed	No outcome recorded
Phase 4	NCT03174158	Nov 2017 → Jan 2019	—	Massachusetts General Hospital	Completed	Missed primary
Phase 4	NCT04045964	Oct 2017 → Jun 2018	environmental induced asthma	The University of Texas Health Science Center, Houston	Completed	No outcome recorded
Phase 4	NCT03315910	Oct 2017 → Oct 2026 expected	—	Memorial Sloan Kettering Cancer Center	Active not recruiting	No outcome recorded
Phase 4	NCT03879889	Feb 2017 → Jul 2019	nicotine dependence	Chinese University of Hong Kong	Completed	Met primary
Phase 4	NCT02905734	Jan 2017 → Nov 2020	nicotine dependence	Assistance Publique - Hôpitaux de Paris	Completed	No outcome recorded
Phase 4	NCT02816138	Oct 2016 → Aug 2017	major depressive disorder	Vanderbilt University Medical Center	Completed	Mixed
Phase 4	NCT02147132	Mar 2016 → Aug 2017	—	University of Cincinnati	Terminated	No outcome recorded Stop: Enrollment
Phase 4	NCT06259630	Nov 2015 → Jun 2018	nicotine dependence	University of Chicago	Withdrawn	No outcome recorded
Phase 4	NCT02562521	Sep 2015 → Dec 2016	—	Yale University	Completed	No outcome recorded
Phase 4	NCT02511236	Aug 2015 → Oct 2019	—	University of Miami	Completed	Met primary
Phase 4	NCT02244918	May 2015 → Nov 2017	—	University of Kansas Medical Center	Completed	No outcome recorded
Phase 4	NCT03262233	Apr 2015 → Feb 2018	nicotine dependence	University of Wisconsin, Madison	Completed	No outcome recorded
Phase 4	NCT02354872	Jan 2015 → Mar 2019	—	University of Wisconsin, Madison	Completed	Missed primary
Phase 4	NCT02371850	Oct 2014 → Apr 2015	—	University of Maryland, Baltimore	Completed	No outcome recorded
Phase 4	NCT02676375	Jan 2014 → Jun 2016	schizophrenia	Brentwood Biomedical Research Institute	Completed	No outcome recorded
Phase 4	NCT01807871	Mar 2013 → Feb 2016	—	University of Vermont	Completed	Missed primary
Phase 4	NCT01783912	Dec 2012 → Jun 2014	mental disorder, nicotine dependence	University of Wisconsin, Madison	Completed	No outcome recorded
Phase 4	NCT01656733	Aug 2012 → Sep 2017	nicotine dependence	UConn Health	Completed	Missed primary
Phase 4	NCT01362959	Jun 2012 → Aug 2016	delirium, nicotine dependence, substance withdrawal syndrome	Gelderse Vallei Hospital	Completed	Missed primary
Phase 4	NCT01429129	May 2012 → Feb 2015	—	Centre for Addiction and Mental Health	Completed	Met primary
Phase 4	NCT01574703	May 2012 → Jul 2015	—	Pfizer	Completed	No outcome recorded
Phase 4	NCT01289275	Aug 2011 → Jul 2014	—	University of California, San Diego	Completed	Missed primary
Phase 4	NCT01622998	Jan 2011 → Aug 2014	—	Ottawa Heart Institute Research Corporation	Completed	No outcome recorded
Phase 4	NCT01122238	Jun 2010 → May 2014	nicotine dependence	University of Wisconsin, Madison	Completed	Missed primary
Phase 4	NCT01120704	Jun 2010 → May 2014	nicotine dependence	University of Wisconsin, Madison	Completed	Met primary
Phase 4	NCT01623505	Jun 2010 → Jun 2014	psychiatric disorder	Ottawa Heart Institute Research Corporation	Completed	Missed primary
Phase 4	NCT01116986	Jun 2010 → May 2014	nicotine dependence	University of Wisconsin, Madison	Completed	Met primary
Phase 4	NCT00962988	Dec 2009 → Apr 2015	cerebrovascular disorder	Ottawa Heart Institute Research Corporation	Completed	No outcome recorded
Phase 4	NCT01010477	Aug 2009 → Jul 2012	schizophrenia	Rutgers, The State University of New Jersey	Completed	Missed primary
Phase 4	NCT00991081	Jul 2009 → Mar 2011	—	Stanford University	Completed	No outcome recorded
Phase 4	NCT01047527	Jun 2009 → Apr 2014	nicotine dependence	University of Pennsylvania	Completed	Missed primary
Phase 4	NCT00959972	Apr 2009 → Nov 2010	coronary artery disorder	Ottawa Heart Institute Research Corporation	Completed	No outcome recorded
Phase 4	NCT00749463	Feb → Nov 2009	nicotine dependence	McNeil AB	Completed	No outcome recorded
Phase 4	NCT00657020	Sep 2007 → Feb 2008	—	GlaxoSmithKline	Completed	No outcome recorded
Phase 4	NCT00320697	Apr 2006 → Oct 2008	schizoaffective disorder, schizophrenia	North Suffolk Mental Health Association	Completed	No outcome recorded
Phase 4	NCT00365508	Feb 2006 → Aug 2009	cervical cancer, esophageal cancer, gastric cancer, head and neck cancer +7	Fox Chase Cancer Center	Completed	No outcome recorded
Phase 4	NCT01576640	Dec 2005 → Oct 2007	nicotine dependence, schizophrenia	Massachusetts General Hospital	Terminated	No outcome recorded
Phase 4	NCT00440830	Dec 2005 → Dec 2008	—	Columbia University	Completed	Missed primary
Phase 4	NCT00235313	Oct 2005 → Nov 2007	—	Assistance Publique - Hôpitaux de Paris	Completed	No outcome recorded
Phase 4	NCT00770666	Sep 2005 → Dec 2007	—	University of Medicine and Dentistry of New Jersey	Completed	Met primary
Phase 4	NCT00625794	Sep 2005 → May 2007	—	University of California, San Francisco	Completed	No outcome recorded
Phase 4	NCT00174499	Jul → Aug 2005	smooth surface dental caries	McNeil AB	Completed	No outcome recorded
Phase 4	NCT00373126	Apr 2005 → ?	schizoaffective disorder, schizophrenia	North Suffolk Mental Health Association	Completed	No outcome recorded
Phase 4	NCT00332644	Sep 2004 → Aug 2010	nicotine dependence	University of Wisconsin, Madison	Completed	No outcome recorded
Phase 4	NCT01980550	Mar → Dec 2004	nicotine dependence	National Institute on Drug Dependence, China	Completed	No outcome recorded
Phase 4	NCT00440505	Feb 2004 → Jun 2008	pelvis syndrome	Columbia University	Completed	No outcome recorded
Phase 4	NCT00232817	Jul 2003 → Jul 2005	—	Columbia University	Completed	No outcome recorded
Phase 4	NCT00224419	Jun 2003 → Aug 2006	pregnancy disorder	Duke University	Terminated	No outcome recorded
Phase 4	NCT00046813	Aug 2001 → Apr 2005	nicotine dependence	National Institute on Drug Abuse (NIDA)	Terminated	No outcome recorded
Phase 4	NCT00320723	Jul 2001 → Dec 2005	schizoaffective disorder, schizophrenia	North Suffolk Mental Health Association	Completed	No outcome recorded
Phase 4	NCT00861276	Jun 2000 → Jul 2001	—	University of Lausanne	Completed	Missed primary
Phase 4	NCT00004551	Feb 1999 → Jan 2003	alcohol dependence	Mayo Clinic	Completed	No outcome recorded
Phase 4	NCT00000447	Sep 1998 → May 2003	alcohol dependence	The University of Texas Health Science Center, Houston	Completed	No outcome recorded
Phase 4	NCT00000437	Sep 1997 → Sep 2005	alcohol dependence	The Scripps Research Institute	Completed	No outcome recorded
Phase 4	NCT00000444	Sep 1997 → Jan 2004	alcohol dependence	Minneapolis Veterans Affairs Medical Center	Completed	No outcome recorded
Phase 4	NCT00000454	? → Aug 2002	alcohol dependence	Yale University	Completed	No outcome recorded

Phase not applicable99 trials · 6 met primary · 8 missed
—	NCT07693660	Dec 2027 → Dec 2031 expected	nicotine dependence	University of Virginia	Not yet recruiting	No outcome recorded
—	NCT07604246	Aug 2026 → Dec 2027 expected	—	Ohio State University Comprehensive Cancer Center	Recruiting	No outcome recorded
—	NCT07075575	Apr 2026 → Nov 2027 expected	nicotine dependence	University of Hawaii	Not yet recruiting	No outcome recorded
—	NCT06584929	Mar 2026 → Oct 2028 expected	—	Masonic Cancer Center, University of Minnesota	Recruiting	No outcome recorded
—	NCT07250230	Nov 2025 → Dec 2026 expected	nicotine dependence	Henan Provincial People's Hospital	Recruiting	No outcome recorded
—	NCT06922617	Oct 2025 → Sep 2028 expected	nicotine dependence	Medical University of South Carolina	Recruiting	No outcome recorded
—	NCT07111234	Sep 2025 → Dec 2026 expected	lung carcinoma	Ohio State University Comprehensive Cancer Center	Recruiting	No outcome recorded
—	NCT07095140	Sep 2025 → Dec 2027 expected	carcinoma	Ohio State University Comprehensive Cancer Center	Recruiting	No outcome recorded
—	NCT05628389	Mar 2024 → Aug 2027 expected	—	University of Florida	Recruiting	No outcome recorded
—	NCT05660525	Mar 2024 → May 2027 expected	nicotine dependence	University of Virginia	Recruiting	No outcome recorded
—	NCT05412875	Jan 2024	head and neck squamous cell carcinoma, non-small cell lung carcinoma	Ohio State University Comprehensive Cancer Center	Withdrawn	No outcome recorded Stop: Business
—	NCT05538910	Feb 2023 → Dec 2027 expected	major depressive disorder, substance-related disorder	National Institute on Drug Abuse (NIDA)	Recruiting	No outcome recorded
—	NCT04258852	Dec 2022 → Feb 2024	—	Yale University	Withdrawn	No outcome recorded Stop: Enrollment
—	NCT05801419	Aug 2022 → Nov 2023	—	Christian Casanova	Completed	No outcome recorded
—	NCT03856515	Jun 2022 → Jun 2024	—	M.D. Anderson Cancer Center	Completed	No outcome recorded
—	NCT05290025	Apr 2022 → Oct 2023 overdue	substance-related disorder	Haukeland University Hospital	Active not recruiting	Met primary
—	NCT05144542	Mar 2022 → Oct 2026 expected	lung carcinoma	M.D. Anderson Cancer Center	Active not recruiting	No outcome recorded
—	NCT05649241	Aug 2021 → Jun 2022	—	University of Virginia	Completed	No outcome recorded
—	NCT04384562	Dec 2020 → Dec 2021	—	University of Zurich	Completed	No outcome recorded
—	NCT03837379	Jun 2020 → May 2022	depressive disorder	Medical University of South Carolina	Completed	No outcome recorded
—	NCT04231539	Feb 2020 → Jul 2024	nicotine dependence	Roswell Park Cancer Institute	Completed	No outcome recorded
—	NCT04190966	Jan 2020 → Jul 2021	—	University of Birmingham	Unknown	No outcome recorded
—	NCT04001972	Aug 2019 → May 2021	nicotine dependence	The University of Hong Kong	Completed	Missed primary
—	NCT03838484	May 2019 → Feb 2020	impulse control disorder, schizophrenia	Vanderbilt University Medical Center	Terminated	No outcome recorded Stop: Enrollment
—	NCT03873337	Apr 2019 → Jan 2022	nicotine dependence, schizoaffective disorder, schizophrenia	Rutgers, The State University of New Jersey	Completed	No outcome recorded
—	NCT03843047	Mar 2019 → Sep 2021	nicotine dependence	Virginia Polytechnic Institute and State University	Completed	No outcome recorded
—	NCT03799315	Jan 2019 → Mar 2020	nicotine dependence	Hennepin Healthcare Research Institute	Completed	Missed primary
—	NCT03717051	Oct 2018 → Dec 2019	—	The University of Hong Kong	Completed	No outcome recorded
—	NCT03416569	Mar 2018 → Jan 2019	—	University of Maryland, Baltimore	Withdrawn	No outcome recorded Stop: Business
—	NCT03097445	Jun 2017 → Aug 2019	—	Centre for Addiction and Mental Health	Completed	No outcome recorded
—	NCT02994082	Dec 2016 → Sep 2019	nicotine dependence	Mark Vander Weg	Unknown	No outcome recorded
—	NCT02935231	Sep → Nov 2016	—	The University of Hong Kong	Completed	No outcome recorded
—	NCT02905656	Sep 2016 → Jun 2020	—	University of Virginia	Completed	Met primary
—	NCT02602288	Feb 2016 → Oct 2019	nicotine dependence	Temple University	Completed	Missed primary
—	NCT03847155	Sep 2015 → Jan 2021	nicotine dependence	University Hospital Ostrava	Completed	No outcome recorded
—	NCT01928719	Sep 2015 → Jan 2018	nicotine dependence	Milton S. Hershey Medical Center	Completed	Missed primary
—	NCT02643914	Sep 2015 → Jun 2017	nicotine dependence	Stony Brook University	Unknown	No outcome recorded
—	NCT01928758	Sep 2015 → Jan 2018	nicotine dependence	Milton S. Hershey Medical Center	Completed	Met primary
—	NCT02239770	Sep 2015 → Oct 2017	—	Milton S. Hershey Medical Center	Completed	No outcome recorded
—	NCT03383224	Jul 2015 → Jul 2025	coronary artery disorder	Washington University School of Medicine	Unknown	No outcome recorded
—	NCT02491086	Jul 2015 → Jan 2016	—	The University of Hong Kong	Completed	No outcome recorded
—	NCT05740098	Jun 2015 → Dec 2019	—	University of Vermont	Completed	No outcome recorded
—	NCT03209622	Jan 2015 → Nov 2017	acute coronary syndrome	University of Monastir	Completed	No outcome recorded
—	NCT02354638	Dec 2014 → Apr 2018	—	Tata Memorial Hospital	Completed	No outcome recorded
—	NCT02420327	Sep 2014 → Mar 2017	—	University of Maryland, Baltimore	Completed	No outcome recorded
—	NCT03626064	Jun 2014 → Mar 2017	nicotine dependence	Ottawa Hospital Research Institute	Completed	No outcome recorded
—	NCT01484340	Mar 2014 → Jun 2016	HIV infectious disease	Johns Hopkins University	Completed	No outcome recorded
—	NCT02102100	Mar 2014 → Jul 2016	nicotine dependence	Yale University	Completed	No outcome recorded
—	NCT02347605	Sep 2013 → Jan 2015	nicotine dependence	University of Minnesota	Completed	Missed primary
—	NCT02049268	Jul 2013 → Dec 2015	alcohol and nicotine codependence	Mclean Hospital	Completed	No outcome recorded
—	NCT01454362	Jan → Mar 2013	mental disorder, substance withdrawal syndrome	Queen Mary University of London	Completed	Missed primary
—	NCT01896518	Nov 2012 → Dec 2014	—	University of Oklahoma	Completed	No outcome recorded
—	NCT01775787	Oct 2012 → Jun 2015	—	UConn Health	Completed	No outcome recorded
—	NCT01368653	Jun 2012 → Jul 2013	nicotine dependence	Rutgers University	Completed	No outcome recorded
—	NCT01596556	Jun 2012 → Dec 2013	—	Sheba Medical Center	Completed	No outcome recorded
—	NCT01935713	Apr → Dec 2012	—	University of Oklahoma	Completed	No outcome recorded
—	NCT03563287	Jan 2012 → Dec 2014	morbid obesity	University of Eastern Finland	Completed	No outcome recorded
—	NCT01341938	Jul 2011 → Nov 2012	—	Oregon Research Institute	Completed	No outcome recorded
—	NCT01705951	Apr 2011 → Dec 2013	cardiovascular disorder	University of California, Los Angeles	Unknown	No outcome recorded
—	NCT00534404	Mar 2011 → Mar 2014	nicotine dependence	University of Michigan	Completed	No outcome recorded
—	NCT01234896	Oct → Nov 2010	nicotine dependence	McNeil AB	Completed	No outcome recorded
—	NCT01223404	Oct 2010 → Sep 2013	nicotine dependence	University of Maryland, Baltimore	Completed	No outcome recorded
—	NCT01734330	Jul 2010 → Sep 2012	—	Hospital do Coracao	Completed	No outcome recorded
—	NCT01889771	Mar 2010 → Mar 2012	—	University of Colorado, Denver	Completed	No outcome recorded
—	NCT01008748	Sep 2009 → Sep 2016	—	M.D. Anderson Cancer Center	Completed	No outcome recorded
—	NCT01227720	Aug → Dec 2009	nicotine dependence	McNeil AB	Completed	No outcome recorded
—	NCT00775749	Apr 2009 → Apr 2012	—	Ochsner Health System	Withdrawn	No outcome recorded
—	NCT00888979	Apr 2009 → May 2011	nicotine dependence	Hartford Hospital	Completed	No outcome recorded
—	NCT00882375	Mar 2009 → Jun 2010	—	McNeil AB	Completed	No outcome recorded
—	NCT01084603	Mar → May 2009	nicotine dependence	McNeil AB	Completed	No outcome recorded
—	NCT01084707	Jan → Mar 2009	nicotine dependence	McNeil AB	Completed	No outcome recorded
—	NCT01152736	Nov → Dec 2008	nicotine dependence	McNeil AB	Completed	No outcome recorded
—	NCT01234792	May → Jun 2008	nicotine dependence	McNeil AB	Completed	No outcome recorded
—	NCT00632411	Apr 2008 → Jul 2014	—	University of Tennessee	Completed	Met primary
—	NCT01152723	Mar → May 2008	nicotine dependence	McNeil AB	Completed	No outcome recorded
—	NCT00631020	Dec 2007 → Oct 2009	—	University of California, Los Angeles	Completed	No outcome recorded
—	NCT01228617	Sep → Oct 2007	nicotine dependence	Johnson & Johnson Consumer and Personal Products Worldwide	Completed	No outcome recorded
—	NCT00606892	Aug 2007 → Nov 2008	—	Yale University	Completed	No outcome recorded
—	NCT00790829	Aug 2007 → Aug 2011	—	Stony Brook University	Terminated	No outcome recorded
—	NCT00407277	Feb 2007 → Aug 2008	nicotine dependence, schizoaffective disorder, schizophrenia, schizophreniform disorder	Centre for Addiction and Mental Health	Completed	No outcome recorded
—	NCT00429208	Feb → Apr 2007	nicotine dependence	Hadassah Medical Organization	Unknown	No outcome recorded
—	NCT00352781	Jul 2006 → Jan 2009	—	Centre for Addiction and Mental Health	Completed	No outcome recorded
—	NCT03717662	Apr 2006 → Oct 2024	—	The University of Hong Kong	Unknown	No outcome recorded
—	NCT01791803	Jan 2006 → May 2009	—	North Shore Medical Center	Completed	Met primary
—	NCT00297466	Jan 2006 → Apr 2007	nicotine dependence	National Institute on Drug Abuse (NIDA)	Completed	Missed primary
—	NCT00390559	Oct 2005 → Mar 2008	drug dependence	Virginia Commonwealth University	Completed	No outcome recorded
—	NCT00356993	Oct 2005 → Mar 2018	—	Centre for Addiction and Mental Health	Completed	No outcome recorded
—	NCT00289653	Sep 2005 → Dec 2006	nicotine dependence	Centre for Addiction and Mental Health	Completed	No outcome recorded
—	NCT00482690	Aug 2005 → Sep 2007	—	University of Nebraska	Terminated	No outcome recorded
—	NCT00573248	Aug 2005 → Dec 2009	attention deficit-hyperactivity disorder	University of California, Irvine	Completed	Mixed
—	NCT00135746	May 2004 → May 2007	nicotine dependence	National Institute on Drug Abuse (NIDA)	Completed	No outcome recorded
—	NCT00425906	Dec 2003 → ?	anorexia nervosa, cancer of unknown primary site, intestinal obstruction	Mayo Clinic	Withdrawn	No outcome recorded Stop: Enrollment
—	NCT00125905	Oct 2003 → Jul 2006	—	Jordi Gol Institute for Primary Care Research	Unknown	Met primary
—	NCT00954096	Oct 2002 → Nov 2006	—	University of Pennsylvania	Completed	No outcome recorded
—	NCT00139516	Sep 2001 → Aug 2007	chronic obstructive pulmonary disease, diabetes mellitus, heart disorder	University of California, San Francisco	Completed	No outcome recorded
—	NCT00021138	Apr 2001 → Mar 2004	esophageal cancer, head and neck cancer, lung cancer	Personal Improvement Computer Systems	Completed	No outcome recorded
—	NCT00018850	Jun 1998 → Jun 2003	schizophrenia	US Department of Veterans Affairs	Completed	No outcome recorded
—	NCT00018213	Apr 1998 → Mar 2001	—	US Department of Veterans Affairs	Completed	No outcome recorded
—	NCT00002520	Dec 1990 → Feb 2002	breast cancer, colorectal cancer, head and neck cancer, lung cancer +5	Eastern Cooperative Oncology Group	Completed	Missed primary

Comparator or background therapy228 trials
Phase 0	NCT06096714 Comparator	Feb 2024 → Sep 2027 expected	nicotine dependence	Yale University	Recruiting	No outcome recorded
Phase 0	NCT05176418 Comparator	Sep 2022 → Oct 2025	nicotine dependence	Yale University	Completed	No outcome recorded
Phase 0	NCT06602492 Comparator	Jul 2021 → Nov 2023	nicotine dependence	Rochester Institute of Technology	Completed	No outcome recorded
Phase 0	NCT04535362 Comparator	Jun 2021 → Jun 2023	nicotine dependence	Yale University	Completed	No outcome recorded
Phase 0	NCT03404596 Background	Jul 2018 → Dec 2020	—	H. Lee Moffitt Cancer Center and Research Institute	Completed	No outcome recorded
Show all 228 trials opens the full record — a long page

News releases announcing trial results or a regulatory action · 14

Date	Issuer	Release
2023-08-09	Lexaria Bioscience Corp.	Results Lexaria's DehydraTECH-Nicotine Faster than ZYN and on! lexariabioscience.com ↗ Lexaria’s oral nicotine pouch was statistically significantly faster in the median time required to reach comparable maximum nicotine concentrations within the bloodstream (“Tmax”), than both on! and ZYN.
2023-05-16	Perrigo Company	Regulatory PERRIGO ANNOUNCES U.S. FDA APPROVAL FOR NICOTINE COATED MINT LOZENGE perrigo.com ↗ Perrigo Company plc (NYSE: PRGO), a leading provider of Consumer Self-Care Products, today announced that it has received final approval from the U.S. Food and Drug Administration for Nicotine Coated Mint Lozenges, 2 mg and 4 mg over-the-counter (OTC).
2021-10-05	Lexaria Bioscience Corp.	Results Lexaria Oral Nicotine Study NIC-A21-1 Delivers Outstanding Results lexariabioscience.com ↗ DehydraTECH-nicotine also reached statistically significant peak blood plasma levels up to 10-fold higher overall than controls (p=0.004) while still clearing from blood virtually as quickly as the controls.
2016-12-20	Perrigo Company	Regulatory Perrigo Announces FDA Approvals For The Store Brand OTC Equivalents To Nicorette® White Ice Mint® Gum perrigo.com ↗ Perrigo Company plc (NYSE: PRGO; TASE) today announced it has received approvals from the U.S. Food and Drug Administration for Abbreviated New Drug Applications referencing GlaxoSmithKline's Nicorette® White Ice Mint® Gum (nicotine polacrilex gum 2 mg and 4 mg).
2016-04-22	Pfizer	Results CHANTIX®/CHAMPIX® (varenicline) Results from the Largest Global Clinical Trial of Smoking Cessation Medicines Published in The Lancet pfizer.com ↗ The authors concluded that the trial did not show a significant increase in the incidence of the composite primary safety endpoint of serious neuropsychiatric adverse events with CHANTIX/CHAMPIX or bupropion compared to placebo and nicotine patch.
2012-10-10	Perrigo Company	Regulatory Perrigo Receives FDA Approval To Market Mini Nicotine Lozenges perrigo.com ↗ The Perrigo Company (Nasdaq: PRGO;TASE) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Applications (ANDA) to market over-the-counter nicotine polacrilex mini lozenge USP, 2 mg (mint flavor) and 4 mg (mint flavor).
2011-07-21	Perrigo Company	Regulatory Perrigo Receives FDA Approval to Market Coated Cinnamon Nicotine Gum perrigo.com ↗ The Perrigo Company (Nasdaq: PRGO;TASE) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) to market over-the-counter coated nicotine polacrilex gum USP, 2 mg and 4 mg cinnamon flavor.
2009-07-13	Perrigo Company	Regulatory Perrigo Receives FDA Approval to Market Cherry and Cinnamon Flavored Nicotine Lozenges perrigo.com ↗ The Perrigo Company (NASDAQ: PRGO)(TASE: PRGO) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) to market over-the-counter coated nicotine polacrilex lozenge USP, 2 mg and 4 mg in cherry and cinnamon flavors.
2008-04-24	Perrigo Company	Regulatory Perrigo Receives FDA Approval to Market Orange, Coated Nicotine Gum perrigo.com ↗ The Perrigo Company (NASDAQ: PRGO)(TASE: PRGO) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) to market over-the-counter (OTC) Nicotine Polacrilex Gum USP, 2 mg (base) and 4 mg (base) (Orange, Coated).
2007-05-30	Perrigo Company	Regulatory Perrigo Receives FDA Approval to Market Coated Fruit Nicotine Gum perrigo.com ↗ The Perrigo Company (NASDAQ: PRGO)(TASE: PRGO) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) to market over-the-counter coated nicotine polacrilex gum USP, 2 mg (coated fruit) and 4 mg (coated fruit).
2006-06-14	Perrigo Company	Regulatory Perrigo Company Receives FDA Approval to Market Coated Nicotine Gum perrigo.com ↗ The Perrigo Company (NASDAQ: PRGO)(TASE: PRGO) announced today that it has received approval from the U. S. Food and Drug Administration (FDA) to market over-the-counter (OTC) coated nicotine polacrilex gum USP, 2 mg (mint) and 4 mg (mint).
2006-02-02	Perrigo Company	Regulatory Perrigo Company Reports Second Quarter Fiscal 2006 Financial Results perrigo.com ↗ The Company announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to market over-the-counter (OTC) nicotine polacrilex lozenges.
2006-02-02	Perrigo Company	Regulatory Perrigo Company Receives FDA Approval to Market Nicotine Lozenges perrigo.com ↗ The Perrigo Company (NASDAQ: PRGO)(TASE: PRGO) announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to market over-the-counter (OTC) nicotine polarcrilex lozenges, 2 mg and 4 mg.
2004-10-05	Perrigo Company	Regulatory Perrigo Company Receives FDA Approval to Market Nicotine Gum and Ibuprofen Oral Suspension perrigo.com ↗ The Perrigo Company (NASDAQ: PRGO) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) to market over-the-counter (OTC) nicotine polacrilex gum and prescription ibuprofen oral suspension.

All press releases naming this drug 19 releases

Date	Issuer	Release
2024-06-26	HALEON	Haleon to divest nicotine replacement therapy business outside of the US to Dr. Reddy's haleon.com ↗
2023-08-09	Lexaria Bioscience Corp.	Lexaria's DehydraTECH-Nicotine Faster than ZYN and on! lexariabioscience.com ↗
2023-05-16	Perrigo Company	PERRIGO ANNOUNCES U.S. FDA APPROVAL FOR NICOTINE COATED MINT LOZENGE perrigo.com ↗
2021-10-05	Lexaria Bioscience Corp.	Lexaria Oral Nicotine Study NIC-A21-1 Delivers Outstanding Results lexariabioscience.com ↗
2019-02-22	Achieve Life Sciences	Achieve Announces Final Data from Cytisinicline Phase I/II Multi-Dose, Pharmacokinetic and Pharmacodynamics (PK/PD) Clinical Study to be Presented at Society for Research on Nicotine & Tobacco Annual Meeting achievelifesciences.com ↗
2016-12-20	Perrigo Company	Perrigo Announces FDA Approvals For The Store Brand OTC Equivalents To Nicorette® White Ice Mint® Gum perrigo.com ↗
2016-04-22	Pfizer	CHANTIX®/CHAMPIX® (varenicline) Results from the Largest Global Clinical Trial of Smoking Cessation Medicines Published in The Lancet pfizer.com ↗
2013-01-22	Perrigo Company	Perrigo Launches Store Brand Version Of Nicorette® Mini Nicotine Lozenges perrigo.com ↗
2012-10-10	Perrigo Company	Perrigo Receives FDA Approval To Market Mini Nicotine Lozenges perrigo.com ↗
2011-07-21	Perrigo Company	Perrigo Receives FDA Approval to Market Coated Cinnamon Nicotine Gum perrigo.com ↗
2010-07-01	GlaxoSmithKline	GSK and EDB commit $35 million (USD) in funding to support research in green and sustainable manufacturing in Singapore gsk.com ↗
2009-11-16	GlaxoSmithKline	GSK and Nabi announce agreement for NicVAX®, a vaccine for nicotine addiction gsk.com ↗
2009-07-13	Perrigo Company	Perrigo Receives FDA Approval to Market Cherry and Cinnamon Flavored Nicotine Lozenges perrigo.com ↗
2008-04-24	Perrigo Company	Perrigo Receives FDA Approval to Market Orange, Coated Nicotine Gum perrigo.com ↗
2007-05-30	Perrigo Company	Perrigo Receives FDA Approval to Market Coated Fruit Nicotine Gum perrigo.com ↗
2006-06-14	Perrigo Company	Perrigo Company Receives FDA Approval to Market Coated Nicotine Gum perrigo.com ↗
2006-02-02	Perrigo Company	Perrigo Company Reports Second Quarter Fiscal 2006 Financial Results perrigo.com ↗
2006-02-02	Perrigo Company	Perrigo Company Receives FDA Approval to Market Nicotine Lozenges perrigo.com ↗
2004-10-05	Perrigo Company	Perrigo Company Receives FDA Approval to Market Nicotine Gum and Ibuprofen Oral Suspension perrigo.com ↗

Evidence & citations 29 cited values

Every value below carries the sentence it was read from. 560 sources stand behind the page.

Field	Value	Cited text
Known as	Nicotine	“Two equally loaded capsules containing: Melatonin (2.0 mg) Nicotine (1.0 mg) Bupropion (37.5 mg) Repaglinide (0.25 mg) Losartan (12.5 mg) Omeprazole (10 mg) Chlorzoxazone...” NCT03563287 ↗ 537 “In a single-arm, open-label study adult smokers (mean cigarettes per day, 25.4 ± 13.4; range, 14-43; n = 12) willing to quit were treated with escalating doses of transdermal...” PMID 23963055 ↗ Oct 2013 “The "standard therapy" treatment arm, or control group, will receive either nicotine patch taper starting at 21 milligrams (mg) daily, nicotine lozenge as needed, and/or...” NCT02676375 ↗ “All participants will receive 8 weeks of combination nicotine replacement therapy (patches plus their choice of gum or lozenges), serial emails with links to Smokefree.gov quit...” PMID 31934869 ↗ Jan 2020 “Subjects randomly assigned to the immediate cessation condition set a quit date soon after enrollment and were offered 2 weeks of nicotine patch therapy to help in their...” PMID 22218402 ↗ Jan 2012 “Options will include nicotine gum (2 and 4 mg), nicotine lozenge (2 and 4 mg), nicotine patch (7, 14, and 21 mg), bupropion (150 mg twice daily) and varenicline (1 mg twice daily).” NCT04501016 ↗ “During the pre-quit and post-quit period, the app will also send messages that encourage the use of the nicotine patch and lozenges according to recommended practices.” NCT04887558 ↗ “Several publications have shown that the use of the nicotine patch during the second and third trimesters is not associated with maternal or fetal compromise.” NCT00744913 ↗ “Pregnant women who smoked ≥5 cigarettes daily received behavioral counseling and random assignment to a 6-week treatment with nicotine or placebo inhaler” PMID 31380506 ↗ Mar 2019 “Integrated smoking cessation pharmacotherapy including choice of combination nicotine replacement therapy, varenicline or electronic cigarettes” NCT04190966 ↗ “Participants in Group B will also receive a two-week "starter kit" sample of nicotine replacement therapy (NRT; 14mg patch and 4mg lozenge).” NCT03837379 ↗ Show 527 more sources
Known as	Aveva	“after the application of the Aveva nicotine patch” NCT02371850 ↗
Known as	Commit	“Self-help materials + Commit® nicotine lozenges (4 mg)” NCT01341938 ↗
Known as	generic Nicotine	“generic Nicotine” NCT01084707 ↗
Known as	Habitrol	“Transdermal nicotine skin patches (i.e. Habitrol) will be used along with supportive counseling in the treatment as usual groups.” NCT02266784 ↗ 2 “Habitrol Nicotine patch - 7,14,21 mg patches Qd” NCT02265874 ↗ “Nicotine Replacement Therapy (Habitrol)” NCT02534454 ↗
Known as	NC001	“Objective: Determine if NC001, an oral formulation of nicotine that reduces levodopa-induced dyskinesias (LIDs) in MPTP-Parkinson monkeys, could reduce falls, freezing of gait...” PMID 31133957 ↗ May 2019
Known as	Nicoderm	“The Nicoderm® patch plus Nicorette® Lozenge will be provided to participants in the combination NRT group.” NCT04286295 ↗
Known as	Nicoderm CQ	“Subjects in both arms were instructed to use one 21-mg (Nicoderm CQ®) nicotine patch daily for 8 weeks followed by one 14-mg patch daily for 2 weeks, then followed by one 7-mg...” NCT00064844 ↗ 8 “NicodermCQ (Nicotine Patches): Administered according to package insert directions” NCT02859142 ↗ “All participants will receive Nicoderm CQ®, 24-hour transdermal nicotine patches” NCT01944423 ↗ “NicoDerm CQ nicotine transdermal patch” NCT00631020 ↗ “Nicoderm CQ transdermal nicotine” NCT00956943 ↗ “Nicoderm CQ nicotine patch” NCT02371850 ↗ NCT04994444 ↗ NCT03999411 ↗ NCT04286295 ↗
Known as	NicoDerm Patch	“Drug: NicoDerm Patch” NCT01622998 ↗
Known as	Nicorette	“Nicotine gum (2 mg uncoated mint Nicorette®) was given for ad libitum use, with encouragement to use at least six pieces per day, up to a maximum of 20 pieces per day.” NCT00064844 ↗ 2 “one box of Nicorette nicotine gums, 2 mg or 4 mg (depending on the number of cigarettes smoked)” NCT06098144 ↗ NCT04286295 ↗
Known as	Nicorette (nicotine)	“Nicorette (nicotine)” NCT02307045 ↗
Known as	Nicorette Nicotine Gum	“Drug: Nicorette® Nicotine Gum” NCT01084603 ↗
Known as	Nicorette, Extreme Chill	“Nicorette, Extreme Chill” NCT01465074 ↗
Known as	Nicotine Bitartrate	“Nicotine Bitartrate Reduces Falls and Freezing of Gait in Parkinson Disease: A Reanalysis.” PMID 31133957 ↗ May 2019
Known as	nicotine dihydrate bitartrate	“Active drug is nicotine dihydrate bitartrate, provided as an oral capsule at escalating doses, 1 mg to 6 mg, once every 6 hours” NCT00957918 ↗
Known as	Nicotine Film	“Drug: Nicotine Film” NCT02239770 ↗
Known as	nicotine gum	“This study aims to help Native Hawaiian adults quit smoking by testing two common methods: nicotine gum and group-based counseling.” NCT07075575 ↗
Known as	Nicotine lozenge	“Drug: Nicotine lozenge” NCT05351606 ↗
Known as	Nicotine patch	“Drug: Nicotine patch” NCT02191033 ↗ 7 “Drug: Nicotine Patch” NCT01048944 ↗ “Drug: Nicotine patch” NCT02487953 ↗ “Drug: Nicotine Patch” NCT01857531 ↗ “Drug: Nicotine Patch” NCT02927847 ↗ “Drug: Nicotine Patch” NCT03029819 ↗ “Drug: Nicotine patch” NCT01056926 ↗ “Drug: Nicotine patch” NCT05351606 ↗
Known as	Nicotine polacrilex	ClinicalTrials.gov intervention name — accepted as the source's own label NCT00086385 ↗ 14 NCT02781090 ↗ NCT01465074 ↗ NCT02869451 ↗ NCT02602288 ↗ NCT01451814 ↗ NCT01935713 ↗ NCT07075575 ↗ NCT01896518 ↗ NCT00482690 ↗ NCT01925781 ↗ Show 4 more sources
Known as	Nicotine Polacrilex Gum	“Nicotine Polacrilex Gum (2 mg)” NCT07075575 ↗
Known as	Nicotrol	ClinicalTrials.gov intervention name — accepted as the source's own label NCT00061074 ↗ 1 NCT01136642 ↗
Known as	Nicotrol NS	“Thus, this pilot trial seeks to evaluate the efficacy of nicotine nasal spray (Nicotrol NS®) in symptomatology of PD.” NCT03865121 ↗
Known as	NiQuitinTM Nicotine Lozenge	“Drug: NiQuitinTM Nicotine Lozenge” NCT01084603 ↗
Known as	NMS	“a nicotine mouth spray (NMS) has been developed.” PMID 30452732 ↗ Mar 2020
Known as	NNS	“OBJECTIVE: To assess the impact of instructional guidance in the regular use of use nicotine nasal spray (NNS) on the true use of NNS during the first three weeks of smoking...” NCT00861276 ↗
Known as	Oral Nicotine	“Drug: Oral Nicotine” NCT01084603 ↗
Action	Activate	“significant activation of nicotinic receptors in the brain and spinal cord” NCT00232817 ↗
Route	Inhaled	“use a nicotine inhaler” NCT00021138 ↗