| Protocol weeks | ||||||||
---|---|---|---|---|---|---|---|---|---|
>−3 | −2 | −1 | 0 | 1-5 | 6 | 8 | 10 | 14-30 | |
End points | |||||||||
Prescreen | ScreenVisit 1 | ScreenVisit 2 | BaselineWK −6 | WK −5 toWK −1 | WK 0Quit Week | WK 2Follow-up | WK 4Follow-up | WK 8, 10, 16, 24Follow-up | |
Measures for screening | |||||||||
Smoking history | Â | X | Â | Â | Â | Â | Â | Â | Â |
Motivation to quit | X | Â | Â | Â | Â | Â | Â | Â | Â |
ASI-16 | X | Â | Â | Â | Â | Â | Â | Â | Â |
Exercise frequency | X | Â | Â | Â | Â | Â | Â | Â | Â |
C-SSRS | Â | X | Â | Â | Â | Â | Â | Â | Â |
SCID-NP | Â | X | Â | Â | Â | Â | Â | Â | Â |
Drug screen | Â | X | Â | Â | Â | Â | Â | Â | Â |
Medical history | Â | Â | X | Â | Â | Â | Â | Â | Â |
Physical exam | Â | Â | X | Â | Â | Â | Â | Â | Â |
Laboratory testing | Â | Â | X | Â | Â | Â | Â | Â | Â |
Maximal exercise testing | Â | Â | X | Â | Â | Â | Â | Â | X |
Measures of post-cessation smoking outcomes | |||||||||
Point prevalence abstinence | Â | Â | Â | X | X | X | X | X | X |
Timeline follow-back | Â | Â | Â | X | Â | X | X | X | X |
Carbon monoxide | Â | X | Â | X | X | X | X | X | X |
Saliva cotinine | Â | Â | Â | Â | Â | Â | Â | Â | X |
Measures of putative mediators | |||||||||
MWS | Â | Â | Â | X | X | X | X | X | X |
ASI-III | Â | Â | Â | X | X | X | X | X | X |
IDAS | Â | Â | Â | X | X | X | X | X | X |
Measures of treatment integrity/acceptance | |||||||||
Credibility/Expectancy | Â | Â | Â | Â | X | Â | Â | Â | Â |
Therapist adherence | Â | Â | Â | Â | X | X | X | X | X |
Patient adherence | Â | Â | Â | Â | X | X | X | X | X |
Fitness | Â | Â | X | Â | Â | Â | Â | Â | X |
Adverse events | Â | Â | Â | Â | X | X | X | X | X |
Concurrent treatment | X | X | Â | X | Â | X | X | X | X |