| |
Responders
|
ITT
|
|---|
|
Variable
|
Intervention
|
Control
|
p-value
|
Intervention
|
Control
|
p-value
|
|---|
|
Outcome measure at 3 months
|
|
7 days abstinence
|
31/101 (30.7%)
|
26/98 (26.5%)
|
0.516
|
31/167 (18.6%)
|
26/147 (17.7%)
|
0.841
|
|
30 days abstinence
|
27/101 (26.7%)
|
22/98 (22.4%)
|
0.483
|
27/167 (16.2%)
|
22/147 (15.0%)
|
0.770
|
|
Continuous abstinence
|
25/101 (24.8%)
|
21/98 (21.4%)
|
0.578
|
25/167 (15.0%)
|
21/147 (14.3%)
|
0.864
|
|
Outcome measure at 6 months
|
|
7 days abstinence
|
28/100 (28.0%)
|
21/99 (21.2%)
|
0.324
|
28/167 (16.8%)
|
21/147 (14.3%)
|
0.546
|
|
30 days abstinence
|
27/100 (27.0%)
|
20/99 (20.2%)
|
0.259
|
27/167 (16.2%)
|
20/147 (13.6%)
|
0.525
|
|
Continuous abstinence
|
23/100 (23.0%)
|
20/99 (20.2%)
|
0.632
|
23/167 (13.8%)
|
20/147 (13.6%)
|
0.966
|
|
Outcome measure at 12 months
|
|
7 days abstinence
|
21/88 (23.9%)
|
14/83 (16.9%)
|
0.257
|
21/167 (12.6%)
|
14/147 (9.5%)
|
0.391
|
|
30 days abstinence
|
21/88 (23.9%)
|
14/83 (16.9%)
|
0.257
|
21/167 (12.6%)
|
14/147 (9.5%)
|
0.391
|
|
Continuous abstinence
|
21/88 (23.9%)
|
14/83 (16.9%)
|
0.257
|
21/167 (12.6%)
|
14/147 (9.5%)
|
0.391
|
|
Continuous abstinence at 12 months incorporating data from visits 3 and 6 and 12‡
|
9/68 (13.2%)
|
6/68 (8.8%)
|
0.412
|
9/167 (5.4%)
|
6/147 (4.1%)
|
0.588
|
- ‡this includes only participants who completed assessment of all outcome measures up to the time indicated
