Table 2.
Treatment outcome in males and females as a function of naltrexone dosage.
| Outcome measures | Male | Female | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Placebo | 25 mg | 50 mg | 100 mg | Chisq/F | P | Placebo | 25 mg | 50 mg | 100 mg | Chisq / F | P | |||
| Smoking abstinence | ||||||||||||||
| Continuous abstinencea | 20 (43.5%) | 22 (45.8%) | 16 (32.0%) | 28 (50.0%) | 3.75 | 0.29 | 16 (34.0%) | 16 (35.6%) | 18 (39.1%) | 25 (53.2%) | 4.45 | 0.217 | ||
| Continuous abstinence, completersa |
20 (55.6%) | 22 (56.4%) | 16 (51.6%) | 28 (71.8%) | 3.63 | 0.305 | 16 (41.0%) | 16 (44.4%) | 18 (45.0%) | 25 (71.4%) * | 8.53 | 0.036 | ||
| Weight change | ||||||||||||||
| Weight changeb | 2.0 ± 1.71 | 0.9 ± 2.3S | 1.0 ± 1.79 | 1.2 ± 2.16 | 1.97 | 0.121 | 1.6 ± 1.73 | 0.6 ± 1.43** | 0.8 ± 1.84 | 1.6 ± 1.48 | 4 | 0.009 | ||
| Weight change, abstinent subjectsb |
1.8 ± 1.42 | 0.9 ± 2.45 | 1.3 ± 1.87 | 1.39 ± 2.29 | 0.69 | 0.561 | 2.1 ± 1.95 | 0.6 ± 1.35* | 0.8 ± 2.03 | 1.7 ± 1.63 | 2.91 | 0.041 | ||
| Weight change, completersb | 2.1 ± 1.69 | 0.9 ± 2.38 | 1.1 ± 1.77 | 1.2 ± 2.16 | 2.1 | 0.103 | 1.6 ± 1.73 | 0.6 ± 1.43* | 0.9 ± 1.88 | 1.6 ± 1.48 | 3.77 | 0.012 | ||
| Adherence | ||||||||||||||
| Completed studya | 36 (78.3%) | 39 (81.3%) | 31 (62.0%) | 39 (69.6%) | 5.6 | 0.133 | 39 (83.0%) | 36 (80.0%) | 40 (87.0%) | 35 (74.5%) | 2.52 | 0.472 | ||
| % medication takenb | 77.9 ± 28.01 | 75.7 ± 30.25 | 69.2 ± 33.38 | 70.4 ± 34.80 | 0.84 | 0.475 | 82.5 ± 24.28 | 75.9 ±31.62 | 81.9 ± 23.73 | 66.0 ± 35.98* | 3.19 | 0.025 | ||
| Adverse events | ||||||||||||||
| Any moderate to severe side effecta |
24 (54.6%) | 25 (54.4%) | 26 (54.2%) | 32(61.5%) | 0.795 | 0.851 | 33(71.7%) | 24 (55.8%) | 28 (62.2%) | 31 (68.9%) | 2.95 | 0.399 | ||
| Any moderate to severe nauseaa | 4 (9.1%) | 4 (8.7%) | 5 (10.4%) | 9 (17.3%) | 2.37 | 0.499 | 5 (10.9%) | 9 (20.9%) | 10 (22.2%) | 14 (31.1%) * | 5.61 | 0.132 | ||
| Drug plasma levels | ||||||||||||||
| Naltrexone concentration, Week 4 (ng/ml,n=221)c |
0 | 1.2 ± 2.4 | 3.3 ± 4.5 | 5,8 ± 9.1## | 4.98 | 0.01 | 0 | 1,5 ± 2.7 | 5.5 ± 9.1 | 11.7 ± 15.7^ ## | 7,74 | 0.001 | ||
| Naltrexol concentration, week 4 (ng/ml, n=221)c |
0 | 13.3 ± 11.91 | 33.5 ±27,96++ | 59.4 ± 41.24^^ ## | 22.26 | <.0001 | 0 | 15.8 ± 19.49 | 42.1 ± 31.11++ | 78.2 ± 55.25^^ ## | 26.08 | <.0001 | ||
a
Logistic regression analyses are conducted separately for men and women, overall Chi-Square and p values are reported.
b
General Linear Models are used separately for men and women, overall F and p values are reported.
c
General Linear Models are used separately for men and women, overall F and p values are reported for active doses.
Each active dose comparing to placebo: *p <.05, ** p <.01.
100mg dose comparing to 50mg dose: ^ p <.05, ^^ p <.01.
100mg dose comparing to 25mg dose: # p <.05, ## p <.01.
50mg dose comparing to25mg dose: + p <.05, ++ p <.01.