Visits | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | 16 | 17 | 18 | 19 | 20 | 21 | 22 | 23 | 24 | 25 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Study Week | -4 to -2 | -2 | -1 | 0 | 1 | 2 | 4 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 16 | 18 | 24 | 26 | 28 | 34 | 40 | 46 | 52/ET |
Study Day | -28 to -14 | -14 | -7 | 0 | 7 | 14 | 28 | 42 | 49 | 56 | 63 | 70 | 77 | 84 | 91 | 98 | 112 | 126 | 168 | 182 | 196 | 238 | 280 | 322 | 364 |
Visit Window (Days) | ±1 | ±1 | ±1 | ±2 | ±2 | ±2 | ±2 | ±2 | ±2 | ±2 | ±2 | ±2 | ±2 | ±2 | ±4 | ±4 | ±4 | ±4 | ±4 | ±5 | ±5 | ±5 | ±5 | ±5 | |
Informed Consent | X | ||||||||||||||||||||||||
Inclusion/Exclusion Criteria | X | ||||||||||||||||||||||||
Medical History1 | X | X | |||||||||||||||||||||||
Tobacco Use History1 | X | X | |||||||||||||||||||||||
Randomize & Assign SID | X | ||||||||||||||||||||||||
Physical Exam1 | X | X | X | ||||||||||||||||||||||
Vital signs and weight2 | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | |||||||
Exhaled Carbon Monoxide | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | ||||||||
Anti-Nicotine Antibody | X | X | X | X | X | X | X | X | X | X | X | X | X | ||||||||||||
Laboratory tests: Hematology, Chemistry | X | X | X | X | |||||||||||||||||||||
Urine Pregnancy Test | X3 | X3 | X | X | X | X | X | ||||||||||||||||||
Urinalysis | X | X | X | X | |||||||||||||||||||||
QUIT DAY | X | ||||||||||||||||||||||||
Quit Re-Challenge | X | X | X | ||||||||||||||||||||||
Clinic Counseling | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | |||||||||
Telephone Counseling | X | X | X | X | X | X | X | ||||||||||||||||||
NicVAX or Placebo | X | X | X | X | X | X | |||||||||||||||||||
Varenicline | X | X | X | X | X | X | X | X | X | X | X | ||||||||||||||
Nicotine Exposure Report Form4 | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X |
Minnesota Nicotine Withdrawal Questionnaire5 | X | X | X | X | X | X | X | X | |||||||||||||||||
Reactogenicity Assessment6 | X | X | X | X | X | X | |||||||||||||||||||
Fagerström Test for Nicotine Dependence (FTND) | X | X | X | X | |||||||||||||||||||||
Adverse Events7 | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | |
Concomitant Medications8 | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X |