TABLE 1.
Demographic characteristics and treatment variables of the overall sample and by treatment condition.
| Overall | no CBT | CBT | ||||||
|---|---|---|---|---|---|---|---|---|
| N=31 | n=13 | n=18 | Test statistic | p value | ||||
|
| ||||||||
| Age, N, M (SD) | 46.29 | 13.06 | 45.08 | 12.72 | 47.17 | 13.60 | 0.19 | 0.67 |
| Sex, n (%) | 1.05 | 0.59 | ||||||
| Male | 6 | 19.4% | 2 | 15.4% | 4 | 22.2% | ||
| Female | 24 | 77.4% | 11 | 84.6% | 13 | 72.2% | ||
| Other | 1 | 3.2% | 0 | 0.0% | 1 | 5.6% | ||
| Race, n (%) | 2.62 | 0.45 | ||||||
| White | 25 | 80.6% | 11 | 84.6% | 14 | 77.8% | ||
| Asian | 1 | 3.2% | 1 | 7.7% | 0 | 0.0% | ||
| Black | 4 | 12.9% | 1 | 7.7% | 3 | 16.7% | ||
| Multiracial | 1 | 3.2% | 0 | 0.0% | 1 | 5.6% | ||
| Ethnicity, n (%) | 0.54 | 0.46 | ||||||
| Hispanic or Latinx | 4 | 12.9% | 1 | 7.7% | 3 | 16.7% | ||
| Not Hispanic or Latinx | 27 | 87.1% | 12 | 92.3% | 15 | 83.3% | ||
| Sexual Orientation, n (%) | 4.31 | 0.23 | ||||||
| Heterosexual | 26 | 83.9% | 13 | 100.0% | 13 | 72.2% | ||
| Gay or Lesbian | 3 | 9.7% | 0 | 0.0% | 3 | 16.7% | ||
| Bisexual | 1 | 3.2% | 0 | 0.0% | 1 | 5.6% | ||
| Other | 1 | 3.2% | 0 | 0.0% | 1 | 5.6% | ||
| Education, n (%) | 0.29 | 0.96 | ||||||
| High School | 2 | 6.5% | 1 | 7.7% | 1 | 5.6% | ||
| Some college | 16 | 51.6% | 6 | 46.2% | 10 | 55.6% | ||
| College | 2 | 6.5% | 1 | 7.7% | 1 | 5.6% | ||
| More than college | 11 | 35.5% | 5 | 38.5% | 6 | 33.3% | ||
|
Treatment Variables*** Stage 1 Initial Treatment, n (%) |
0.06 | >0.99 | ||||||
| Received placebo | 14 | 45.2% | 6 | 46.2% | 8 | 44.4% | ||
| Received NB | 13 | 41.9% | 7 | 53.8% | 6 | 33.3% | ||
| Received BWL+placebo | 2 | 6.5% | 0 | 0.0% | 2 | 11.1% | ||
| Received BWL+NB | 2 | 6.5% | 0 | 0.0% | 2 | 11.1% | ||
|
Stage 2 Continuing Medication |
0.35 | 0.68 | ||||||
| Continued placebo | 14 | 45.2% | 6 | 46.2% | 8 | 44.4% | ||
| Continued NB | 9 | 29.0% | 5 | 38.4% | 4 | 22.2% | ||
| None (due to adverse event) | 8 | 25.8% | 2 | 15.4% | 6 | 33.3% | ||
Note: Test statistic = chi-square for categorical variables and ANOVAs for dimensional variables.
M = mean. SD = standard deviation. N = number; P values are for two-tailed tests.
CBT = cognitive behavioral therapy
The acute (Stage 1) treatment was a 2X2 balanced factorial design, and when considered separately, the N=31 participants in this trial testing CBT had received one of the following four initial acute (Stage 1) treatment conditions: placebo, naltrexone/bupropion (NB), behavioral weight loss (BWL) plus placebo, or behavioral weight loss plus naltrexone/bupropion (BWL+NB). The treatment variables summarized in this Table show the distributions of the four “Stage 1 Initial Treatment” conditions and show the “Stage 2 Continuing Medication” conditions (i.e., continued placebo, continued naltrexone/bupropion, or no medication because discontinued due to adverse event), which did not differ, separately for CBT and no-CBT.