title: Randomised clinical trial of snus versus medicinal nicotine among smokers interested in product switching.
abstract: BACKGROUND
  An essential component of evaluating potential modified risk tobacco products is to determine how consumers use the product and resulting effects on biomarkers of toxicant exposure.
  
  
  METHODS
  Cigarette smokers (n=391) recruited in Minnesota and Oregon were randomised to either snus or 4 mg nicotine gum for 12 weeks. Participants were instructed to completely switch from cigarettes to these products. Urine samples were collected to analyse for carcinogenic tobacco-specific nitrosamine metabolites (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol and N'-nitrosonornicotine and their glucuronides) and nicotine metabolites (total cotinine and nicotine equivalents) levels.
  
  
  RESULTS
  Of the 391 participants randomised, 52.9% were male, the mean±SD age was 43.9±12.5 years, baseline number of cigarettes/day was 18.0±6.5 and Fagerstrom Test for Nicotine Dependence score was 5.1±2.0. The mean±SD number of snus pouches used/week at week 6 prior to tapering was 39.1±24.0 and nicotine gum pieces used was 37.6±26.3. Dual use of cigarettes and these products were observed in 52.9% and 58.2% of those assigned to snus and nicotine gum, respectively, at week 12. The end of treatment biochemically verified (carbon monoxide, CO<6 ppm) 7-day avoidance of cigarettes was 21.9% in the snus group and 24.6% in the nicotine gum group. Toxicant exposure in the nicotine gum group was significantly less when compared to snus.
  
  
  CONCLUSIONS
  Snus performed similarly to nicotine gum in cigarette smokers who were interested in completely switching to these products, but was associated with less satisfaction and greater toxicant exposure than nicotine gum.
  
  
  BACKGROUND
  NCT: 00710034.
authors.affiliation: Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota, USA Department of Psychiatry, University of Minnesota, Minneapolis, Minnesota, USA.
authors.forename: Dorothy K
authors.initials: DK
authors.lastname: Hatsukami
authors.affiliation: Oregon Research Institute, Eugene, Oregon, USA.
authors.forename: Herbert
authors.initials: H
authors.lastname: Severson
authors.affiliation: Department of Psychiatry, University of Minnesota, Minneapolis, Minnesota, USA.
authors.forename: Amanda
authors.initials: A
authors.lastname: Anderson
authors.affiliation: Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota, USA.
authors.forename: Rachael Isaksson
authors.initials: RI
authors.lastname: Vogel
authors.affiliation: Department of Psychiatry, University of Minnesota, Minneapolis, Minnesota, USA.
authors.forename: Joni
authors.initials: J
authors.lastname: Jensen
authors.affiliation: Oregon Research Institute, Eugene, Oregon, USA.
authors.forename: Berry
authors.initials: B
authors.lastname: Broadbent
authors.affiliation: Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota, USA.
authors.forename: Sharon E
authors.initials: SE
authors.lastname: Murphy
authors.affiliation: Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota, USA.
authors.forename: Steven
authors.initials: S
authors.lastname: Carmella
authors.affiliation: Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota, USA.
authors.forename: Stephen S
authors.initials: SS
authors.lastname: Hecht
mesh_terms: D000284:Administration, Oral; D000328:Adult; D015415:Biomarkers / Q000652:urine; D002638:Chewing Gum; D003258:Consumer Behavior; D003367:Cotinine / Q000652:urine; D005260:Female; D020719:Glucuronides / Q000652:urine; D006801:Humans; D008297:Male; D008875:Middle Aged; D008910:Minnesota; D009538:Nicotine / Q000008:administration & dosage* / Q000009:adverse effects / Q000652:urine; D018722:Nicotinic Agonists / Q000008:administration & dosage* / Q000009:adverse effects / Q000652:urine; D009602:Nitrosamines / Q000652:urine; D009922:Oregon; D011725:Pyridines / Q000652:urine; D012907:Smoking / Q000009:adverse effects; D016540:Smoking Cessation / Q000379:methods*; D000074606:Smoking Prevention; D013997:Time Factors; D061485:Tobacco Use Cessation Devices / Q000009:adverse effects; D014029:Tobacco Use Disorder / Q000628:therapy*; D014030:Tobacco, Smokeless / Q000009:adverse effects; D016896:Treatment Outcome; D016482:Urinalysis
chemical_list: D015415:Biomarkers; D002638:Chewing Gum; D020719:Glucuronides; D018722:Nicotinic Agonists; D009602:Nitrosamines; D011725:Pyridines; D009538:Nicotine; C099565:4-(methylnitrosamino)-1-(3-pyridyl)-1-butan-1-ol; D003367:Cotinine; C008655:N'-nitrosonornicotine
keywords: Carcinogens; Harm Reduction; Non-cigarette tobacco products