title: Effects of nicotine withdrawal on cognition in a clinical trial setting.
abstract: BACKGROUND
  Smoking withdrawal has been widely established to produce a range of impairments to the quality of several major domains of cognitive function including attention, working memory and episodic memory.
  
  
  OBJECTIVE
  This study was conducted to determine the degree to which smoking withdrawal will produce impairments in cognitive function in phase I clinical trials.
  
  
  METHODS
  Healthy male volunteers who were housed in a clinical trial facility for 16 days underwent periods of ad libitum smoking and smoking withdrawal.
  
  
  RESULTS
  Smoking withdrawal disrupted aspects of attention and episodic verbal recall and recognition.
  
  
  CONCLUSIONS
  This study confirms previous work showing cognitive declines in smoking withdrawal and illustrates that such effects occur in ongoing safety and tolerability studies of new medicines and thus require careful consideration for the assessment of cognitive function in such trials as well as the accurate attribution of adverse events to the safety profiles of the medicines.
authors.affiliation: Bracket, 19 Gatehampton Road, Goring-on-Thames, Oxon RG8 0EN, UK. keith.wesnes@bracketglobal.com
authors.forename: Keith A
authors.initials: KA
authors.lastname: Wesnes
authors.forename: Chris J
authors.initials: CJ
authors.lastname: Edgar
authors.forename: Iva
authors.initials: I
authors.lastname: Kezic
authors.forename: Hiba Mahde
authors.initials: HM
authors.lastname: Salih
authors.forename: Peter
authors.initials: P
authors.lastname: de Boer
mesh_terms: D000328:Adult; D003071:Cognition / Q000187:drug effects / Q000502:physiology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009538:Nicotine / Q000009:adverse effects*; D011930:Reaction Time / Q000187:drug effects / Q000502:physiology; D012907:Smoking / Q000453:epidemiology / Q000523:psychology; D016540:Smoking Cessation / Q000523:psychology*; D013375:Substance Withdrawal Syndrome / Q000175:diagnosis / Q000453:epidemiology / Q000523:psychology*; D055815:Young Adult
chemical_list: D009538:Nicotine