Table 2.
Primary outcome | Secondary outcomes | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Two week abstinence in Weeks 7 and 8 |
Retention | Maximum number of consecutive days of abstinence |
Average dollars per day of use | Days of use per week |
Withdrawal Scale |
|||||||
Observed | PBO | DRO | PBO | DRO | PBO | DRO | PBO | DRO | PBO | DRO | PBO | DRO |
Count(%) or median (IQR) |
12/77 (15.6) |
14/79 (17.7) |
47/77 (61.0) |
61/79 (77.2) |
5 (2-16) |
6 (1-13) |
NA | NA | NA | NA | NA | NA |
Modeled | Wald X2 | P Value | Log-rank X2 | P Value | F Value | P Value | F Value | P Value | Wald X2 | P Value | F Value | P Value |
Baseline value | 0.51 | 0.47 | NA | - | 2.03 | 0.16 | NM | NM | 0.14 | 0.71 | NM | NM |
Treatment | 0.16 | 0.69 | 5.03 | 0.02 | 0.07 | 0.79 | NM | NM | 0.38 | 0.54 | NM | NM |
Time | NA | - | NA | - | NA | - | NM | NM | 78.72 | <.001 | NM | NM |
Time * Treatment | NA | - | NA | - | NA | - | NM | NM | NA | - | 1.91 | 0.02 |
Time * Trx * Baseline | NA | - | NA | - | NA | - | 4.71 | <.001 | NA | - | NA | - |
Abbreviations: PBO, placebo; DRO, dronabinol; Trx, treatment; NA, not applicable; NM, not meaningful.