Table 3.
Follow-up | Trial measures |
Baseline (wk -2) |
Smoking history, demographics, nicotine dependence using Fagerstrom Test for Nicotine Dependence (FTND)[49], urges and withdrawal (MPSS[51]), confidence in quitting, smoking stereotypy[48], cigarette satisfaction[47], future orientation questionnaire, exhaled carbon monoxide (CO), salivary cotinine, Give out diaries. |
Pre-quit visit (wk -1) | CO, cotinine, MPSS, confidence, smoking stereotypy, cigarette satisfaction, adverse events. Collect diaries with daily smoking, NRT use, MPSS urge questions. Give out diaries. |
Extra pre-quit visit (wk -1a) |
Only applicable if delays quit date by 1 week CO, MPSS, confidence, smoking stereotypy, cigarette satisfaction, adverse events. Collect diaries with daily smoking, NRT use. Give out diaries. |
Extra pre-quit visit (wk -1b) |
Only applicable if delays quit date by 2 weeks CO, MPSS, confidence, smoking stereotypy, cigarette satisfaction, adverse events. Collect diaries with daily smoking, NRT use. Give out diaries. |
Quit day (wk 0) |
CO, cotinine, MPSS, confidence, smoking stereotypy, cigarette satisfaction, adverse events. Collect diaries with daily smoking, NRT use, MPSS urge questions. Give out diaries. |
One week after quit day (wk +1) | CO, cotinine, MPSS, confidence, cigarette satisfaction if lapsed, adverse events Collect diaries with daily smoking, NRT use, MPSS urge questions |
Post-quit visits (wks +2, +3, +4) | Smoking in past week, CO, MPSS, confidence, cigarette satisfaction if lapsed, future orientation questionnaire at week 4, amount NRT used, adverse events |
+8 wk visit | Smoking in past 4 weeks, CO, MPSS, cigarette satisfaction if lapsed, confidence, amount NRT used, adverse events |
6-month telephone call | Smoking status over past 5 months, use of NRT. Those claiming 7-day abstinence will be invited to a validation visit for exhaled CO and to complete the future orientation questionnaire. Serious adverse events (SAEs) |