Table 1.
Subject characteristics and secondary outcome variables in the ITT (intention-to-treat) sample.
| Group | Data were expressed as mean ± SD or no. (%) | Placebo vs. naltrexone baseline | Placebo vs. naltrexone Diff. treatment - baseline | ||||
|---|---|---|---|---|---|---|---|
| Placebo | Naltrexone | cohens d (95% CI) | |||||
| Demographics | |||||||
| Participants (males/females) | 24 (20/4) | 22 (20/2) | χ²(1) = 0.581; p = 0.446 | ||||
| Age (yrs, mean ± SD) [min–max] | 29, 8 ± 5,5 (25–50) | 29, 4 + 6,2 (25–54) | t(44) = 0.243; p = 0.809 | ||||
| Regular smokers (%) | 14 (58.3) | 16 (72.7) | χ²(1) = 1.048; p = 0.306 | ||||
| OPRM1-G carriers (%) | 9 (37.5) | 8 (36.4) | χ²(1) = 0.006; p = 0.936 | ||||
| Family history of alcoholism (%) | 4 (16.7) | 3 (13.6) | χ²(1) = 0.082; p = 0.775 | ||||
| Education | χ²(4) = 3.712; p = 0.446 | ||||||
| No vocational training (%) | 3 (12.5) | 0 | |||||
| Vocational training ongoing (%) | 2 (8.3) | 2 (9.1) | |||||
| Completed vocational training (%) | 7 (29.2) | 5 (22.7) | |||||
| Ongoing university education (%) | 8 (33.3) | 9 (40.9) | |||||
| University degree (%) | 4 (16.7) | 6 (27.3) | |||||
| Baseline clinical symptom ratings | |||||||
| Alcohol dependence scale | 5.87 ± 2.94 | 7.45 ± 4.17 | t(43) = −1.478; p = 0.147 | ||||
| AUDIT | 13.29 ± 3.928 | 14.36 ± 3.723 | t(44) = −0.948; p = 0.348 | ||||
| Secondary outcome measures | Baseline | During treatment | Baseline | During treatment | |||
| OCDS-score | 8.8 ± 3.9 | 7.3 ± 4.1* | 9.1 ± 4.3 | 8.8 ± 4.3 | t(44) = −0.291; p = 0.772 | t(38) = −0.310; p = 0.759 | d = −0.099 (−0.726–0.529) |
| % drinking days | 69.7 ± 15.1 | 63.5 ± 20.2 | 73.7 ± 15.5 | 67.0 ± 20.8* | t(44) = −0.894; p = 0.376 | t(44) = 0.101; p = 0.920 | d = 0.030 (−0.549–0.608) |
| % binge days | 47.5 ± 16.2 | 41.3 ± 18.7 | 47.1 ± 16.6 | 39.6 ± 18.0* | t(44) = 0.088; p = 0.93 | t(44) = 0.281; p = 0.78 | d = 0.083 (−0.496–0.661) |
| Grams alcohol/drinking day | 109.7 ± 40.8 | 105.3 ± 40.8 | 107.7 ± 43.4 | 101.7 ± 49.5 | t(44) = 0.168; p = 0.867 | t(43) = 0.176; p = 0.861 | d = 0.053 (−0.534–0.638) |
| % CDT | 1.67 ± 1.76 | 2.03 ± 2.29 | 2.30 ± 3.60 | 2.14 ± 3.49 | t(44) = −0.757; p = 0.453 | t(44) = 1.838; p = 0.073 | d = 0.543 (−0.050–1.129) |
| GGT (µmol/s*l) | 0.60 ± 0.35 | 0.59 ± 0.33 | 0.75 ± 0.55 | 0.71 ± 0.73 | t(44) = −1.130; p = 0.265 | t(44) = 0.488; p = 0.628 | d = 0.144 (−0.436–0.722) |
| ALAT (µmol/s*l) | 0.55 ± 0.31 | 0.5 ± 0.28 | 0.55 ± 0.18 | 0.53 ± 0.17 | t(44) = −0.042; p = 0.967 | t(44) = −0.397; p = 0.693 | d = −0.117 (−0.696–0.262) |
| ASAT (µmol/s*l) | 0.48 ± 0.13 | 0.46 ± 0.15 | 0.48 ± 0.12 | 0.46 ± 1.13 | t(44) = 0.144; p = 0.886 | t(44) = −0.219; p = 0.828 | d = −0.065 (−0.643–0.515) |
| Peak BrAC (mg%) | 114 ± 22 | 111 ± 27 | 119 ± 25 | 107 ± 33 | t(44) = −0.88; p = 0.384 | t(44)=1.287; p = 0.205 | d = 0.380 (−0.206–0.962) |
| Mean BrAC (mg%) | 91 ± 21 | 87 ± 24 | 96 ± 21 | 85 ± 29 | t(44) = −0.86; p = 0.395 | t(43) = 1.020; p = 0.313 | d = 0.305 (−0.286–0.892) |
| Cumulative work for saline | 98.13 ± 113.84 | 145.71 ± 182.94 | 60.91 ± 63.28 | 96.14 ± 115.03 | t(44) = 1.344; p = 0.177 | t(44) = 0.361; p = 0.720 | d = 0.106 (−0.473–0.685) |
All particiapants were of caucasian ethnicity.
ALAT alanine aminotransferase, ASAT aspartate aminotransferase, AUDIT alcohol use disorders identification test, BrAC breath alcohol concentration, CDT carbohydrate-deficient Transferrin, OCDS obsessive compulsive drinking scale, OPRM-1 opioid receptor Mu 1.
*Significantly different from baseline at p < 0.05.