Table 1.
Demographics of White Participants Who Provided Genetic Samples by Treatment Conditiona
| Medical Management (No CBI) |
CBI + Medical Management |
|||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Total Sample |
Placebo |
Naltrexone Hydrochloride |
Placebo |
Naltrexone Hydrochloride |
||||||
|
Characteristic |
Asn40 (n=469) |
Asp40 (n=135) |
Asn40 (n=126) |
Asp40 (n=35) |
Asn40 (n=115) |
Asp40 (n=31) |
Asn40 (n=109) |
Asp40 (n=33) |
Asn40 (n=119) |
Asp40 (n=36) |
| Demographics | ||||||||||
| Age, y, mean (SD) | 45.6 (10.49) | 44.8 (10.51) | 45.2 (10.09) | 46.1 (12.08) | 45.7 (11.17) | 42.5 (10.01) | 45.8 (10.05) | 45.6 (9.53) | 45.7 (10.73) | 44.8 (10.28) |
| Sex, No. (%) M | 332 (70.8) | 91 (67.4) | 91 (72.2) | 23 (65.7) | 77 (67.0) | 21 (67.7) | 81 (74.3) | 24 (72.7) | 83 (69.7) | 23 (63.9) |
| Married, No. (%) | 214 (45.6) | 52 (38.5) | 50 (39.7) | 10 (28.6) | 51 (44.3) | 11 (35.5) | 61 (56.0) | 15 (45.5) | 52 (43.7) | 16 (44.4) |
| Employed, No. (%) | 344 (73.3) | 110 (81.5) | 91 (72.2) | 31 (88.6) | 88 (76.5) | 20 (64.5) | 82 (75.2) | 26 (78.8) | 83 (69.7) | 33 (91.7) |
| Education≤high school, No. (%) | 124 (26.4) | 35 (25.9) | 36 (28.6) | 11 (31.4) | 30 (26.1) | 8 (25.8) | 25 (22.9) | 11 (33.3) | 33 (27.7) | 5 (13.9) |
| Current smoker, No. (%) | 206 (43.9) | 58 (43.0) | 51 (40.5) | 13 (37.1) | 54 (47.0) | 13 (41.9) | 39 (35.8) | 16 (48.5) | 62 (52.1) | 16 (44.4) |
| Alcohol use severity indicators, mean (SD) | ||||||||||
| % of days abstinentb | 23.9 (24.58) | 21.9 (23.91) | 24.5 (25.37) | 19.9 (23.99) | 23.9 (24.38) | 26.9 (27.73) | 19.8 (22.44) | 21.6 (23.38) | 27.1 (25.55) | 19.6 (20.99) |
| Drinks per drinking dayb | 12.6 (7.54) | 11.8 (7.14) | 12.4 (6.69) | 12.3 (8.37) | 12.6 (8.37) | 13.4 (9.14) | 12.4 (7.36) | 11.5 (5.19) | 12.8 (7.81) | 10.2 (5.10) |
| Overall drinks per dayb | 9.3 (6.18) | 9.2 (6.78) | 9.2 (6.17) | 9.5 (7.38) | 9.2 (6.14) | 10.5 (9.48) | 9.7 (5.97) | 8.6 (4.15) | 9.0 (6.47) | 8.3 (5.27) |
| Heavy drinking daysb | 20.0 (8.36) | 20.6 (8.10) | 20.1 (8.40) | 20.4 (7.98) | 19.9 (8.49) | 19.8 (9.10) | 21.1 (7.89) | 21.2 (7.90) | 19.1 (8.58) | 20.9 (7.79) |
| DSM-IV symptoms | 5.5 (1.26) | 5.5 (1.23) | 5.6 (1.29) | 5.4 (1.14) | 5.5 (1.27) | 5.6 (1.36) | 5.6 (1.21) | 5.6 (1.19) | 5.5 (1.27) | 5.3 (1.26) |
| Alcohol dependence scorec | 16.6 (7.26) | 16.9 (7.93) | 17.2 (7.30) | 16.6 (7.45) | 16.2 (7.43) | 18.1 (10.36) | 16.5 (6.99) | 17.7 (7.18) | 16.6 (7.36) | 15.3 (6.58) |
| OCDS score | 26.0 (7.11) | 26.5 (7.24) | 26.7 (7.50) | 24.6 (6.53) | 25.2 (7.33) | 25.8 (7.91) | 26.8 (5.96) | 28.2 (7.95) | 25.4 (7.37) | 27.2 (6.38) |
| Drinking consequences scored | 47.8 (19.91) | 46.5 (20.52) | 49.6 (20.06) | 46.8 (21.31) | 46.2 (20.05) | 45.2 (21.52) | 48.1 (19.78) | 47.0 (20.61) | 47.2 (19.81) | 47.1 (19.58) |
| GGT, IU/L, | 68.8 (112.4) | 61.8 (82.49) | 81.0 (168.7) | 59.3 (63.46) | 62.4 (74.90) | 63.3 (80.15) | 60.3 (53.88) | 64.6 (99.93) | 69.7 (107.4) | 60.5 (86.51) |
| % CDT | 3.5 (2.06) | 3.2 (1.84) | 3.7 (2.55) | 3.3 (2.27) | 3.3 (1.84) | 3.1 (1.59) | 3.5 (1.95) | 3.5 (2.12) | 3.5 (1.77) | 2.9 (1.14) |
| No. (%) | ||||||||||
| GGT>63 IU/L | 137 (29.2) | 33 (24.4) | 36 (28.6) | 9 (25.7) | 32 (27.8) | 8 (25.8) | 34 (31.2) | 10 (30.3) | 35 (29.4) | 6 (16.7) |
| CDT>2.5% | 227 (48.4) | 58 (43.0) | 63 (50.0) | 16 (45.7) | 50 (43.5) | 12 (38.7) | 57 (52.3) | 17 (51.5) | 57 (47.9) | 13 (36.1) |
Abbreviations: CBI, combined behavioral intervention; CDT, carbohydrate-deficient transferrin; GGT, γ-glutamyltransferase; OCDS, obsessive compulsive drinking scale.
SI conversion factor: To convert GGT to microkatals per liter, multiply by 0.01667.
Differences across treatment and genotypes were not significant. For the total sample and within each treatment combination, Asn40 (Asn40/Asn40 homozygote) individuals were compared with Asp40 carriers (Asn40Asp or Asp40Asp). For those receiving CBI plus medical management and naltrexone, “employed” had P=.004. All other P values were greater than .05.
In the 30 days before randomization.
Assessed using the Alcohol Dependence Scale.57
Assessed using the Drinker Inventory of Consequences scale.58