PMID- 30452732
OWN - NLM
STAT- MEDLINE
DCOM- 20200904
LR  - 20200904
IS  - 1469-994X (Electronic)
IS  - 1462-2203 (Linking)
VI  - 22
IP  - 3
DP  - 2020 Mar 16
TI  - Efficacy and Safety of a Nicotine Mouth Spray for Smoking Cessation: A 
      Randomized, Multicenter, Controlled Study in a Naturalistic Setting.
PG  - 339-345
LID - 10.1093/ntr/nty246 [doi]
AB  - BACKGROUND: Nicotine replacement therapy (NRT) has been demonstrated to be an 
      effective pharmacological treatment for smoking cessation, and most types of NRT 
      have been approved as over-the-counter (OTC) medications. In an effort to create 
      a fast-acting, flexible, and discreet NRT, a nicotine mouth spray (NMS) has been 
      developed. This study was designed to assess the efficacy and safety of NMS in a 
      naturalistic setting in the United States. METHODS: This was a multicenter, 
      randomized, double-blind, placebo-controlled, parallel-group, 26-week study in 
      1198 smokers motivated to quit. The study was designed to resemble an OTC 
      environment, and thus included limited intervention, limited motivational 
      screening, and no behavioral support. The primary efficacy endpoint was carbon 
      monoxide-verified, self-reported continuous abstinence from smoking from week 2 
      until week 6. The safety of NMS was assessed by measuring vital signs, visual 
      mouth inspection, and collection of subject-reported adverse events (AEs). 
      RESULTS: The percentage of subjects with carbon monoxide-verified continuous 
      abstinence from week 2 to week 6 was statistically significantly greater in the 
      NMS group compared with the placebo group (5.0% vs. 2.5%, p = .021). 
      Statistically significant treatment effects for the NMS were maintained 
      throughout the 26-week period. The study medications were generally well 
      tolerated. The severity of AEs was similar for both treatment groups, and most 
      AEs were of mild or moderate severity. CONCLUSIONS: These study results 
      demonstrate that the NMS is an effective and safe smoking cessation option for 
      smokers motivated to quit, even in a naturalistic setting and without behavioral 
      support. IMPLICATIONS: This study demonstrated the safety, efficacy, and 
      acceptability of an NMS in an OTC environment with no behavioral counseling or 
      support. It provides an additional option for smokers motivated to quit. TRIAL 
      REGISTRATION: ClinicalTrials.gov (number NCT02355665).
CI  - (c) The Author(s) 2018. Published by Oxford University Press on behalf of the 
      Society for Research on Nicotine and Tobacco.
FAU - Nides, Mitchell
AU  - Nides M
AD  - Los Angeles Clinical Trials, Burbank, CA.
FAU - Danielsson, Tobias
AU  - Danielsson T
AD  - McNeil AB, Helsingborg, Sweden.
FAU - Saunders, Frederick
AU  - Saunders F
AD  - GSK Consumer Healthcare, Warren, NJ.
FAU - Perfekt, Roland
AU  - Perfekt R
AD  - McNeil AB, Helsingborg, Sweden.
FAU - Kapikian, Roxanne
AU  - Kapikian R
AD  - GSK Consumer Healthcare, Warren, NJ.
FAU - Solla, Janice
AU  - Solla J
AD  - McNeil Consumer Healthcare Division, Johnson & Johnson Consumer Inc., Fort 
      Washington, PA.
FAU - Leischow, Scott J
AU  - Leischow SJ
AD  - Mayo Clinic Arizona, Scottsdale, AZ.
FAU - Myers, Andrew
AU  - Myers A
AD  - McNeil Consumer Healthcare Division, Johnson & Johnson Consumer Inc., Fort 
      Washington, PA.
LA  - eng
SI  - ClinicalTrials.gov/NCT02355665
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Nicotine Tob Res
JT  - Nicotine & tobacco research : official journal of the Society for Research on 
      Nicotine and Tobacco
JID - 9815751
RN  - 0 (Nicotinic Agonists)
RN  - 6M3C89ZY6R (Nicotine)
RN  - 7U1EE4V452 (Carbon Monoxide)
SB  - IM
MH  - Carbon Monoxide/analysis
MH  - Counseling/methods
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Nicotine/*administration & dosage
MH  - Nicotinic Agonists/*administration & dosage
MH  - Smoking/*therapy
MH  - Smoking Cessation/*methods
MH  - Tobacco Use Cessation Devices/*statistics & numerical data
MH  - Treatment Outcome
EDAT- 2018/11/20 06:00
MHDA- 2020/09/05 06:00
CRDT- 2018/11/20 06:00
PHST- 2018/02/09 00:00 [received]
PHST- 2018/11/14 00:00 [accepted]
PHST- 2018/11/20 06:00 [pubmed]
PHST- 2020/09/05 06:00 [medline]
PHST- 2018/11/20 06:00 [entrez]
AID - 5188017 [pii]
AID - 10.1093/ntr/nty246 [doi]
PST - ppublish
SO  - Nicotine Tob Res. 2020 Mar 16;22(3):339-345. doi: 10.1093/ntr/nty246.