Combining ondansetron and naltrexone treats biological alcoholics: Corroboration of self-reported drinking by serum carbohydrate deficient transferrin, a biomarker

Background: Recently, we showed by using self-report that combining ondanse tron (4 mu /kg twice a day) and naltrexone (25 mg twice a day) was effectiv e at reducing drinking and increasing abstinence among early-onset alcoholi cs (EOAs), who are characterized by a range of antisocial behaviors and hig h biological and familial disease predisposition. Here, we investigated whe ther the self-reported differences in drinking would be corroborated by mea surements of serum carbohydrate-deficient transferrin (CDT) level, a sensit ive, reliable, and well-validated marker of transient alcohol consumption. Method: An 8-week double-blind clinical trial was performed in which 20 EOA s were randomized to receive ondansetron (4 mug/kg twice a day) and naltrex one (25 mg twice a day) or placebo as an adjunct to weekly standardized cog nitive behavioral therapy. Serum CDT was assessed at weeks 0 (baseline), 4, and 8. Results: Log serum CDT was significantly lower in the ondansetron and naltr exone group (group mean, 1.44 +/-: 0.076) compared with the placebo group ( group mean, 1.82 +/- 0.113), as evidenced by a main effect of group [F(1,15 ) = 7.2,p = 0.017; effect size = 0.32], visit [F(1,16) = 11.2, p = 0.004; e ffect size = 0.41], and an interaction between group and visit [F(1,16) = 2 7.54,p < 0.001; effect size = 0.63]; Conclusions: The combination of ondansetron plus naltrexone was superior to placebo at reducing serum CDT. This corroborated our self-reported drinkin g data and demonstrated that the medication combination is an effective tre atment for EOAs.