Table 3.
NX versus PL |
NX versus NX + Ser |
||||||
---|---|---|---|---|---|---|---|
Placebo (n = 34) |
NX (n = 34) |
NX + SER (n = 33) |
p-value | OR/HR/ES (LL/UL) | p-value | OR/HR/ES (LL/UL) | |
ITT sample | |||||||
Primary outcomes | |||||||
Total abstinence (n, %) | 4(12) | 12(35) | 10 (30) | 0.027 | 4.37 (1.19/16.11)a | 0.634 | 1.30 (0.45/3.77)a |
Relapse to a heavy | 28 (82) | 22 (65) | 22 (67) | 0.093 | 1.64 (0.92/2.90)b | 0.874 | 0.95 (0.53/1.73)b |
drinking day (n, %) | |||||||
Secondary outcomes | |||||||
Percent days abstinent (Mean, SD) |
85.7 (2.96) | 94.8 (3.09) | 96.3 (3.08) | 0.024 | 0.53(0.03/1.02)c | 0.710 | 0.09 (−0.40/0.58)c |
Percent days heavy drinking (Mean, SD) |
11.2 (2.92) | 3.7 (3.02) | 3.0 (3.04) | 0.059 | 0.44 (−0.05/0.93)c | 0.859 | 0.04 (−0.45/0.53)c |
Drinks per drinking day (Mean, SD) |
3.9 (0.82) | 3.6 (0.85) | 1.9 (0.85) | 0.728 | 0.08 (−0.40/0.56)c | 0.131 | 0.35 (−0.14/0.85)c |
GGT change from baseline (Mean, SD) |
19.2 (13.46) | 23.2 (13.39) | 43.2(13.61) | 0.964 | 0.05 (−0.44/0.55)c | 0.427 | 0.26 (−0.23/0.76)c |
DrInC (n, % reporting any problems) |
22 (76) | 14(45) | 14 (47) | 0.020 | 0.264 (0.09/0.81)a | 0.948 | 0.97 (0.35/2.68)a |
Alcohol Urge Questionnaire (Mean, SD) |
12.8 (0.96) | 12.3 (0.97) | 13.5(1.03) | 0.671 | 0.11 (−0.42/0.64)c | 0.353 | 0.23 (−0.30/0.77)c |
CES-Depression (Mean, SD) | 10.1 (0.93) | 10.9 (0.94) | 9.8 (0.97) | 0.520 | 0.16 (−0.37/0.69)c | 0.383 | 0.22 (−0.32/0.76)c |
(n = 22) | (n = 24) | (n = 22) | |||||
Native subsample | |||||||
Primary outcomes | |||||||
Total abstinence (n, %) | 4(18) | 8(33) | 8(36) | 0.224 | 2.42 (0.58/10.11)a | 0.880 | 0.91 (0.26/3.20)a |
Relapse to a heavy drinking day (n, %) |
17(77) | 16(67) | 14 (64) | 0.224 | 1.56 (0.76/3.20)b | 0.972 | 0.99 (0.48/2.04)b |
Secondary outcomes | |||||||
Percent days abstinent | 88.8 (3.03) | 96.6 (2.90) | 96.9 (3.02) | 0.060 | 0.56 (−0.05/1.16)c | 0.930 | 0.03 (−0.57/0.62)c |
Percent days heavy drinking | 8.5 (2.91) | 2.8 (2.76) | 0.6 (2.90) | 0.142 | 0.43 (−0.17/1.03)c | 0.578 | 0.16 (−0.43/0.75)c |
Drinks per drinking day | 4.2 (0.93) | 4.0 (0.89) | 1.9 (0.92) | 0.830 | 0.06 (−0.53/0.65)c | 0.095 | 0.50 (−0.10/1.10)c |
GGT change from baseline | 21.8(18.81) | 17.2 (16.98) | 61.0(18.52) | 0.975 | 0.06 (−0.55/0.66)c | 0.141 | 0.54 (−0.08/1.16)c |
DrInC (n, % reporting any problems) | 13(72) | 8(38) | 8(42) | 0.026 | 0.20 (0.05/0.83)a | 0.715 | 0.785 (0.21/2.88)a |
Alcohol Urge Questionnaire | 11.2 (1.25) | 12.6(1.16) | 13.4(1.33) | 0.405 | 0.27 (−0.39/0.93)c | 0.637 | 0.15 (−0.50/0.81)c |
CES-Depression | 10.2 (1.21) | 11.8 (1.12) | 10.2 (1.21) | 0.295 | 0.34 (−0.32/0.99)c | 0.310 | 0.33 (−0.32/0.98)c |
OR, odds ratio; HR, hazard ratio; ES, effect size estimates are reported as Cohen’s d-values; LL/UL, lower limit/upper limit.
OR.
HR.
ES.