Table 4.
Study schedule of combustion-free nicotine alternatives (C-F NA) supply and use checks (only for arm B).
| Procedure | Screening | Enrollment (V0) | Baseline (V1) | Week | |||||||||||
|
|
|
|
|
4 | 8 | 12 (V2) | 20 | 24 (V3) | 32 | 40 | 48 | 52 (V4) | 60 | 68 | 76 (V5) |
| C-F NA use |
|
|
✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Provide C-F NA device |
|
|
✓ |
|
|
|
|
|
|
|
|
|
|
|
|
| Hand out 2 weeks supply of consumablesb |
|
|
✓ |
|
|
|
|
|
|
|
|
|
|
|
|
| Hand out 4 weeks supply of consumablesa |
|
|
|
✓ | ✓ |
|
✓ |
|
|
|
✓ |
|
|
|
|
| Hand out 2×4 weeks supply of consumablesb |
|
|
|
|
|
✓ |
|
✓ | ✓ | ✓ |
|
✓ | ✓ | ✓ | ✓ |
| Product use checks (collect used and unused consumablesb) |
|
|
|
✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
aParticipants wishing to use a heated tobacco product will receive one kit and supply of tobacco sticks of their choice; they will receive the number of tobacco sticks per day corresponding to the number of cigarettes smoked per day at baseline. Participants wishing to use a vaping product will receive one vaping kit and supply of e-liquids of their choice.