PMID- 33735416
OWN - NLM
STAT- MEDLINE
DCOM- 20211122
LR  - 20220218
IS  - 1970-9366 (Electronic)
IS  - 1828-0447 (Print)
IS  - 1828-0447 (Linking)
VI  - 16
IP  - 7
DP  - 2021 Oct
TI  - A double blind randomized controlled trial investigating efficacy and safety of 
      varenicline for smoking cessation in patients with type 2 diabetes: study 
      protocol.
PG  - 1823-1839
LID - 10.1007/s11739-021-02684-1 [doi]
AB  - Reducing exposure to cigarette smoke is an imperative for public health and for 
      diabetic patients. Patients with diabetes who continue to smoke face challenges 
      at quitting and the delivery of effective smoking cessation interventions is a 
      major unmet need. The high-affinity alpha4beta2 nicotinic acetylcholine receptor partial 
      agonist varenicline in combination with counseling is effective for smoking 
      cessation, but evidence in patients with diabetes is limited. A clinical trial of 
      varenicline targeted specifically at smokers with T2DM is warranted. This 
      randomized, double blind, placebo-controlled trial will be the first study to 
      test efficacy and safety of varenicline in smokers with type 2 diabetes mellitus 
      (T2DM) over the course of 52 weeks. We hypothesize that varenicline treatment 
      (1 mg BID, administered for 12 weeks) would increase quit rates, maintain smoking 
      abstinence up to 1 year after treatment, and be well-tolerated in T2DM smokers 
      intending to quit. Efficacy end points will include carbon monoxide-confirmed 
      continuous abstinence rate (CAR) and 7-day point prevalence of abstinence. The 
      results of this RCT will help inform medical/health authorities and physicians 
      worldwide whether an optimally varenicline-treated cohort of T2DM patients who 
      smoke will experience significant success rates, without significant side 
      effects.Trial registration NCT01387425 ( 
      https://clinicaltrials.gov/ct2/show/NCT01387425 ).
CI  - (c) 2021. The Author(s).
FAU - Russo, C
AU  - Russo C
AD  - Ambulatorio Di Diabetologia, UOC Medicina Interna E D'Urgenza, Policlinico 
      Universitario, AOU "Policlinico-V. Emanuele", Catania, Italy.
FAU - Caponnetto, P
AU  - Caponnetto P
AD  - Centro Per La Prevenzione E Cura del Tabagismo (CPCT), Azienda 
      Ospedaliero-Universitaria "Policlinico-V.Emanuele" Dell'Universita Di Catania, 
      Via S. Sofia 78, 95123, Catania, Italy.
FAU - Cibella, F
AU  - Cibella F
AD  - Institute for Biomedical Research and Innovation, National Research Council of 
      Italy, Palermo, Italy.
FAU - Maglia, M
AU  - Maglia M
AD  - Centro Per La Prevenzione E Cura del Tabagismo (CPCT), Azienda 
      Ospedaliero-Universitaria "Policlinico-V.Emanuele" Dell'Universita Di Catania, 
      Via S. Sofia 78, 95123, Catania, Italy.
FAU - Alamo, A
AU  - Alamo A
AD  - Centro Diabetologico - UOC Andrologia Ed Endocrinologia, Policlinico 
      Universitario, AOU "Policlinico-V. Emanuele", Catania, Italy.
FAU - Campagna, D
AU  - Campagna D
AD  - Ambulatorio Di Diabetologia, UOC Medicina Interna E D'Urgenza, Policlinico 
      Universitario, AOU "Policlinico-V. Emanuele", Catania, Italy.
AD  - UOC MCAU, University Teaching Hospital "Policlinico-Vittorio Emanuele", 
      University of Catania, Catania, Italy.
FAU - Frittitta, L
AU  - Frittitta L
AD  - Centro Per Il Diabete E L'Obesita - UOC Endocrinologia, Ospedale Garibaldi 
      Nesima, ARNAS Garibaldi, Catania, Italy.
AD  - Center of Excellence for the Acceleration of HArm Reduction (CoEHAR), 
      Dipartimento Di Medicina Clinica E Sperimentale, Universita Di Catania, Catania, 
      Italy.
FAU - Di Mauro, M
AU  - Di Mauro M
AD  - Center of Excellence for the Acceleration of HArm Reduction (CoEHAR), 
      Dipartimento Di Medicina Clinica E Sperimentale, Universita Di Catania, Catania, 
      Italy.
AD  - Ambulatorio Di Diabetologia, Ospedale V. Emanuele, AOU "Policlinico-V. Emanuele", 
      Catania, Italy.
FAU - Leotta, C
AU  - Leotta C
AD  - Ambulatorio Di Diabetologia - UOC Geriatria, Ospedale Cannizzaro, Catania, Italy.
FAU - Mondati, E
AU  - Mondati E
AD  - Center of Excellence for the Acceleration of HArm Reduction (CoEHAR), 
      Dipartimento Di Medicina Clinica E Sperimentale, Universita Di Catania, Catania, 
      Italy.
AD  - UOS Sorveglianza Delle Complicanze Delle Malattie Metaboliche, Ospedale S. Marta, 
      AOU "Policlinico-V. Emanuele", Catania, Italy.
FAU - Krysinski, A
AU  - Krysinski A
AD  - Mossakowski Clinical Research Centre, Polish Academy of Sciences, Warsaw, Poland.
AD  - Department of Internal Diseases, Endocrinology and Diabetology, Central Clinical 
      Hospital MSWiA, Warsaw, Poland.
FAU - Franek, E
AU  - Franek E
AD  - Mossakowski Clinical Research Centre, Polish Academy of Sciences, Warsaw, Poland.
AD  - Department of Internal Diseases, Endocrinology and Diabetology, Central Clinical 
      Hospital MSWiA, Warsaw, Poland.
FAU - Polosa, R
AU  - Polosa R
AUID- ORCID: 0000-0002-8450-5721
AD  - Ambulatorio Di Diabetologia, UOC Medicina Interna E D'Urgenza, Policlinico 
      Universitario, AOU "Policlinico-V. Emanuele", Catania, Italy. polosa@unict.it.
AD  - Centro Per La Prevenzione E Cura del Tabagismo (CPCT), Azienda 
      Ospedaliero-Universitaria "Policlinico-V.Emanuele" Dell'Universita Di Catania, 
      Via S. Sofia 78, 95123, Catania, Italy. polosa@unict.it.
AD  - Center of Excellence for the Acceleration of HArm Reduction (CoEHAR), 
      Dipartimento Di Medicina Clinica E Sperimentale, Universita Di Catania, Catania, 
      Italy. polosa@unict.it.
LA  - eng
SI  - ClinicalTrials.gov/NCT01387425
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20210318
PL  - Italy
TA  - Intern Emerg Med
JT  - Internal and emergency medicine
JID - 101263418
RN  - 0 (Smoking Cessation Agents)
RN  - W6HS99O8ZO (Varenicline)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Diabetes Mellitus, Type 2
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - *Smoking Cessation
MH  - Smoking Cessation Agents/*therapeutic use
MH  - Tobacco Use Disorder/*drug therapy
MH  - Treatment Outcome
MH  - Varenicline/*therapeutic use
MH  - Young Adult
PMC - PMC8502165
OTO - NOTNLM
OT  - Diabetes mellitus
OT  - Randomized controlled trial
OT  - Smoking cessation
OT  - Varenicline
COIS- RP is full-time employee of the University of Catania, Italy and Medical Director 
      of the Institute for Internal Medicine and Clinical Immunology at the same 
      University. In relation to his work in the area of tobacco control and 
      respiratory diseases, RP has received has received lecture fees and research 
      funding from Pfizer, GlaxoSmithKline, CV Therapeutics, NeuroSearch A/S, Sandoz, 
      MSD, Boehringer Ingelheim, Novartis, Duska Therapeutics, and Forest Laboratories. 
      He has also served as a consultant for Pfizer, Global Health Alliance for 
      treatment of tobacco dependence, CV Therapeutics, Boehringer Ingelheim, Novartis, 
      Duska Therapeutics, ECITA (Electronic Cigarette Industry Trade Association, in 
      the UK), Arbi Group Srl., and Health Diplomats. RP has served on the Medical and 
      Scientific Advisory Board (MSAB) of Cordex Pharma, Inc., CV Therapeutics, Duska 
      Therapeutics Inc, Pfizer, and PharmaCielo. Lecture fees from a number of European 
      EC industry and trade associations (including FIVAPE in France and FIESEL in 
      Italy) were directly donated to vaper advocacy no-profit organizations. RP is 
      also founder of: 1) the Center for Tobacco prevention and treatment (CPCT) at the 
      University of Catania; and 2) the Center of Excellence for the acceleration of 
      Harm Reduction (CoEHAR) at the same University, which has received support from 
      Foundation for a Smoke Free World to conduct 8 independent investigator-initiated 
      research projects on harm reduction. RP is also currently involved in the 
      following pro bono activities: scientific advisor for LIAF, Lega Italiana Anti 
      Fumo (Italian acronym for Italian Anti-Smoking League), the Consumer Advocates 
      for Smoke-free Alternatives (CASAA) and the International Network of Nicotine 
      Consumers Organizations (INNCO); Chair of the European Technical Committee for 
      standardization on "Requirements and test methods for emissions of electronic 
      cigarettes" (CEN/TC 437; WG4). PC is paid by the University of Catania as an 
      external part time researcher and adjunct professor of clinical, addiction and 
      general psychology. He has been affiliated to the CoEHAR since December 2019 in a 
      pro bono role. He is co-author of a protocol paper supported by an 
      Investigator-Initiated Study award program established by Philip Morris 
      International in 2017. All other authors have no relevant conflict of interest to 
      declare in relation to this study.
EDAT- 2021/03/19 06:00
MHDA- 2021/11/23 06:00
PMCR- 2021/03/18
CRDT- 2021/03/18 17:49
PHST- 2021/01/30 00:00 [received]
PHST- 2021/02/22 00:00 [accepted]
PHST- 2021/03/19 06:00 [pubmed]
PHST- 2021/11/23 06:00 [medline]
PHST- 2021/03/18 17:49 [entrez]
PHST- 2021/03/18 00:00 [pmc-release]
AID - 10.1007/s11739-021-02684-1 [pii]
AID - 2684 [pii]
AID - 10.1007/s11739-021-02684-1 [doi]
PST - ppublish
SO  - Intern Emerg Med. 2021 Oct;16(7):1823-1839. doi: 10.1007/s11739-021-02684-1. Epub 
      2021 Mar 18.