Table 1.
Assessment Schedule
| Assessment & Source | Schedule (weeks)a |
|---|---|
| Adverse events | Each Contact |
| Breath alcohol concentration (BAC) | SCR, BL, 2, 3, 4, 6, 8, 10, 12, 14, 15, 17 |
| Brief Drinking Assessment | SCR, 19 |
| Blood chemistriesb | SCR, 4, 15 |
| Clinical Institute Withdrawal Assessment for Alcohol - Revised (CIWR–AR) (Sullivan et al., 1989) | Each Contact |
| Concomitant medications | Each Contact |
| Demographics | SCR |
| Drinker Inventory of Consequences (DrInC) (Miller, 1995) | BL, 4, 8, 12, 15, 17 |
| Electrocardiogram (ECG) | SCR, 17 |
| Fagerstrom Test for Nicotine Dependence (Heatherton et al., 1991) | BL, 8, 15 |
| Hamilton Anxiety Scale (HAM-A) (Guy, 1976) | BL, 4, 8, 12, 15, 17 |
| Hematology | SCR, 4, 15 |
| Locator form | SCR |
| Medical history | SCR |
| MINI Screen/MINI | SCR |
| Montgomery-Asberg Depression Rating Scale (MADRS) (Montgomery and Asberg, 1979) | SCR, BL, 4, 8, 12, 15, 17 |
| Motivation to Reduce Drinking | SCR |
| Physical exam | SCR |
| Profile of Moods Questionnaire (POMS) | BL, 2, 3, 4, 12, 17 |
| Prior medications (past 30 days) | SCR |
| Quality of Life Short Form 12 (SF-12) (Szabo, 1996) | BL, 15 |
| Services utilization | BL, 8, 17 |
| Suicidality monitoring | Each Contact |
| Time-Line Follow-Back (Sobell and Sobell, 1992)c | SCR, BL, 2, 3, 4, 6, 8, 10, 12, 14, 15, 17 |
| Treatment compliance | 2, 3, 4, 6, 8, 10, 12, 14, 15, 17 |
| Urine drug screen | SCR, BL, 2, 3, 4, 6, 8, 10, 12, 14, 15, 17 |
| Urine pregnancy test | SCR, BL, 4, 8, 12, 17 |
| Vital signs (blood pressure, heart rate, and respiration rate) and weight | SCR, BL, 2, 3, 4, 6, 8, 10, 12, 14, 15, 17 |
SCR=screening; BL=baseline
a
All assessments were conducted in the clinic, except for weeks 5, 7, 9, 11, 13, 16, 19 which were conducted via telephone.
b
Blood chemistries were assessed after ≥2 hours of fasting; repeated after ≥8 hours if blood glucose or triglycerides were elevated.
c
TLFB methodology in conjunction with a modified Form 90 (Miller, 1996) was used to assess daily drinking for the past 90 days at baseline and since the last assignment during treatment.