Smoking [Design Issues]

posted by Helmut Homepage – Vienna, Austria, 2014-12-17 18:48 (4212 d 01:16 ago) – Posting: # 14097
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Dear Ohlbe,

❝ Helmut, couldn't a sudden smoking cessation also influence the gastrointestinal motility, or sumfink like this ?


Absolutely (GI transit time may increase). Either include only non-smokers (confirmed by cotinine tests) or allow (moderate) smokers to smoke. :smoke:
In the latter case a dedicated area is a must (check that smokers don’t exceed the daily allowance stated in the protocol). If the clinical site doesn’t have a smoking area, include only non-smokers. Sending smokers to the street and exposing them to demanding climatic conditions (winter in Moscow or Saskatoon easily –40 ℃; summer-monsoon in India) is not an alternative.

But again: In a crossover whatever one has chosen shouldn’t matter. I would not suggest that smokers refrain from smoking during hospitalization. Their craving symptoms might even annoy other volunteers and the clinical staff.

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