Table 1.
No. (%) | |||||||
---|---|---|---|---|---|---|---|
Characteristic | Total (n=68) | Gabapentin (n=37) | Placebo (n=31) | p valuea | |||
Age, mean (SD), y | 49.3 | 10.6 | 49.6 | 10.4 | 48.9 | 10.9 | 0.78 |
PTSD (current or past) | 18 | 26.5% | 9 | 24.3% | 9 | 29.0% | 0.66 |
Nicotine use | 31 | 45.6% | 17 | 45.9% | 14 | 45.2% | 0.95 |
Antidepressant use | 18 | 26.5% | 9 | 24.3% | 9 | 29.0% | 0.66 |
Sex (male) | 50 | 73.5% | 28 | 75.7% | 22 | 71.0% | 0.66 |
Married/cohabitating | 29 | 42.6% | 19 | 51.4% | 10 | 32.3% | 0.11 |
Education (≤ 12 y) | 8 | 11.8% | 5 | 13.5% | 3 | 9.7% | 0.62 |
Employed | 49 | 72.1% | 26 | 70.3% | 23 | 74.2% | 0.72 |
Race (white) | 65 | 95.6% | 35 | 94.6% | 30 | 96.8% | 0.66 |
Alcohol use and severity indicators, mean (SD) | |||||||
Drinks per dayb | 11.0 | 4.6 | 10.8 | 4.3 | 11.2 | 5.0 | 0.77 |
Drinks per drinking dayb | 13.0 | 4.8 | 13.2 | 4.9 | 12.8 | 4.8 | 0.72 |
Days abstinent, %b | 14.1% | 21.3% | 14.9% | 22.7% | 13.3% | 19.8% | 0.76 |
Heavy drinking days, %b | 83.0% | 22.3% | 82.8% | 23.6% | 83.2% | 21.0% | 0.94 |
Days abstinent prior to randomization | 4.2 | 2.0 | 4.2 | 2.1 | 4.2 | 1.9 | 0.97 |
Alcohol Dependence Scalec | 18.6 | 7.5 | 19.7 | 7.8 | 17.4 | 7.1 | 0.22 |
OCDSd | 27.4 | 9.4 | 27.9 | 9.1 | 26.7 | 9.9 | 0.62 |
Alcohol Withdrawal Symptom Checkliste | 10.5 | 7.0 | 10.9 | 7.4 | 9.9 | 6.4 | 0.53 |
DSM-5 alcohol withdrawal items positive | 4.5 | 1.3 | 4.7 | 1.1 | 4.4 | 1.5 | 0.36 |
CIWA | 2.8 | 1.8 | 2.8 | 2.0 | 2.8 | 1.6 | 0.95 |
Past alcohol: | |||||||
Treatments | 19 | 27.9% | 13 | 35.1% | 6 | 19.4% | 0.15 |
Detoxifications | 9 | 13.2% | 7 | 18.9% | 2 | 6.5% | 0.13 |
Alcohol blood tests (biomarkers) | |||||||
%dCDT≥1.7 | 50 | 74.6% | 26 | 72.2% | 24 | 77.4% | 0.63 |
GGT > 36 U/L | 52 | 76.5% | 29 | 78.4% | 23 | 74.2% | 0.69 |
Abbreviations: PTSD, Posttraumatic Stress Disorder; DSM-5, Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition); GGT, y-glutamyltransferase; OCDS, Obsessive Compulsive Drinking Scale; %dCDT, percentage of disialo carbohydrate-deficient transferrin.
The χ2 statistic was used for all the categorical variables, and the ANOVA statistic was used for all the continuous variables.
Calculated using the 90 days prior to screening.
Range, 0–47.
Range, 0–56.