Table 1. Baseline Characteristics of Patients.
| Placebo (n=101) | Varenicline (n=97) | ||||||
|---|---|---|---|---|---|---|---|
|
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| n | Mean or % | SD | n | Mean or % | SD | p-valuea | |
|
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| Demographics | |||||||
| Age | 101 | 45.0 | 12.3 | 97 | 46.0 | 11.0 | 0.571 |
| Male | 69 | 68.3% | 71 | 73.2% | 0.451 | ||
| Employed | 77 | 76.2% | 69 | 71.1% | 0.415 | ||
| Married | 38 | 37.6% | 44 | 45.4% | 0.269 | ||
| Education (≥ high school) | 72 | 71.3% | 60 | 61.9% | 0.159 | ||
| Race/Ethnicity | 0.300 | ||||||
| White | 71 | 70.3% | 60 | 61.9% | 0.210 | ||
| Black | 27 | 26.7% | 30 | 30.9% | 0.515 | ||
| Hispanic | 2 | 2.0% | 2 | 2.1% | 1.000 | ||
| Other | 1 | 1.0% | 5 | 5.2% | 0.113 | ||
| Self-Reported Alcohol Consumptionb | |||||||
| Drinks per day | 101 | 12.5 | 8.9 | 97 | 14.2 | 9.3 | 0.147 |
| Drinks per drinking day | 101 | 13.6 | 9.0 | 97 | 15.3 | 9.6 | 0.118 |
| Percent days abstinent | 101 | 7.9 | 13.6 | 97 | 7.7 | 12.5 | 0.995 |
| Percent heavy drinking days | 101 | 87.2 | 16.4 | 97 | 88.1 | 15.8 | 0.680 |
| Percent very heavy drinking days (8+/10+) | 101 | 57.8 | 35.6 | 97 | 66.2 | 35.0 | 0.132 |
| Other Substance-Related Indicators | |||||||
| Penn Alcohol Craving Scale (PACS) score | 101 | 16.7 | 6.8 | 97 | 17.7 | 6.2 | 0.276 |
| Alcohol-related consequences (ImBIBe) score | 101 | 16.3 | 9.7 | 96 | 17.8 | 9.8 | 0.220 |
| Age of onset of regular drinking | 101 | 19.3 | 5.5 | 97 | 18.7 | 6.1 | 0.418 |
| Alcohol-related treatment goal (abstinence vs. other) | 28 | 27.7% | 27 | 27.8% | 0.986 | ||
| Parental history of alcohol-related problems | 50 | 49.5% | 52 | 53.6% | 0.564 | ||
| Current smoker (any vs. none) | 41 | 41.0%c | 37 | 38.1% | 0.727 | ||
| Cigarettes per day (past-week) among smokers | 41 | 11.3 | 6.7 | 37 | 11.5 | 7.22 | 0.960 |
| Fagerström Test for Nicotine Dependence (FTND) score | 41 | 3.1 | 2.6 | 36 | 3.0 | 2.4 | 0.852 |
| Marijuana used | 12 | 12.0% | 14 | 14.4% | 0.614 | ||
| GGT | 101 | 70.8 | 103.2 | 97 | 72.9 | 123.49 | 0.666 |
| Psychiatric Characteristics | |||||||
| SF-12 Mental Aggregate score | 100 | 50.2 | 9.2 | 97 | 48.1 | 10.4 | 0.195 |
| SF-12 Physical Aggregate score | 100 | 52.2 | 6.0 | 97 | 50.7 | 8.8 | 0.445 |
| Clinical Institute Withdrawal Assessment of Alcohol (CIWA) score | 101 | 1.3 | 1.7 | 97 | 1.3 | 1.5 | 0.561 |
a
Group mean differences were tested for significance via t-tests of independent samples for normally-distributed variables or Wilcoxon rank-sum tests for skewed variables. Group prevalence rate differences were tested for significance via chi-square or Fisher's exact tests.
b
Reflects mean values during the 28-day period (Days 1-28) before screening.
c
The denominator for the placebo group includes 100 patients.
d
Marijuana use based on positive urine drug screen.
Note: Scale, number of questions (range), and interpretive values are as follows:
- PACS: 5 questions (0-30)
- ImBIBe: 15 questions (0-60)
- FTND: 6 questions (0-10) (Heatherton et al., 1991)
- SF-12: 7 questions (T-score 0-100), 50 normal functioning
- CIWA: 10 questions (0-67), ≥10 indicative of alcohol withdrawal