Table 2.
Outcome | Predictors | ||||
---|---|---|---|---|---|
Baseline (effect of baseline for the adjusted model) |
PBO | VEN-XR | Time (effect of time for the longitudinal outcomes) |
Time by Treatment Interaction (effect of time by treatment) |
|
(effect of treatment) | |||||
50% reduction of
HAMD at end of study (unadjusted and adjusted by baseline) |
X12=0.04, p-value=0.84 |
36/52 69.2% |
32/51 62.7% |
N/Aa | N/Aa |
Unadjusted by baseline: X12=0.48, p-value=0.49 Adjusted by baseline: X12=0.44, p-value=0.51 | |||||
< 8 on the HAMD at end
of study (unadjusted and adjusted by baseline) |
X12=4.95, p-value=0.03 |
30/52 57.7% |
26/51 51.0% |
N/Aa | N/Aa |
Unadjusted by baseline: X12=0.47, p-value=0.49 Adjusted by baseline: X12=0.95, p-value=0.33 | |||||
At least two consecutive
abstinent weeks (unadjusted and adjusted by baseline THC urine level creatinine corrected) |
X12=7.65, p-value<0.01 |
19/52 36.5% |
6/51 11.8% |
N/Aa | N/Aa |
Unadjusted by baseline: X12=7.87, p-value<0.01 Adjusted by baseline: X12=7.46, p-value<0.01 | |||||
HAMD over time
(adjusted by baseline HAMD) |
F1,456=19.25, p-value<0.01 |
Week 12 mean=5.65 |
Week 12 mean=6.61 |
F6,456=43.45, p-value<0.01 |
N/Ab |
F1,456=0.76, p-value=0.38 | |||||
THC urine levels
creatinine corrected over time |
N/A | Week 12 mean=439 |
Week 12 mean=1403 |
F6,372=2.94, p-value<0.01d |
F6,372=3.25, p-value<0.01 (See Figure 2) |
F1,372=9.06, p-value<0.01d | |||||
Self reported use in
grams over time |
N/A | Week 12 mean=4.51 |
Week 12 mean=7.18 |
F6,340=5.84, p-value<0.01 |
N/Ac |
F1,340=0.99, p-value=0.32 | |||||
Treatment (effect of treatment) |
HAMD (effect of HAMD score) |
HAMD by Treatment Interaction (effect of HAMD by treatment) |
|||
THC urine levels
creatinine corrected (repeated over time) |
F1,365=19.52, p-value<0.01d |
F1,365=17.47, p-value<0.01d |
F1,365=16.11, p-value<0.01 (See Figure 3) |
||
PBO: | F1,179=30.49, p-value<0. 01e |
N/A | |||
VEN-XR: | F1,186=0.02, p-value=0.89e |
N/A |
Time and Time by Treatment interaction were not predictors in non-longitudinal models.
Time by Treatment interaction was not significant (F6,450 = 0.99, p-value =0.43) and was left out of the final model.
Time by Treatment interaction was not significant (F6,334 = 1.54, p-value =0.17) and was left out of the final model.
Part of the model, but not interpretable. The results must be interpreted through the interaction term.
Separate analyses for the PBO an VEN-XR groups to investigate a effect of HAMD on THC urine level creatinine corrected. In the VEN-XR group there was not a significant relationship between HAMD score and THC urine levels; For the PBO group, THC urine levels were significantly associated with HAMD score.