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 ondansetron (4 microg/kg twice a day) and naltrexone (25 mg twice a day) was effective at reducing drinking and increasing abstinence among early-onset alcoholics (EOAs), who are characterized by a range of antisocial behaviors and high biological and familial disease predisposition. Here, we investigated whether the self-reported differences in drinking would be corroborated by measurements of serum carbohydrate-deficient transferrin (CDT) level, a sensitive, reliable, and well-validated marker of transient alcohol consumption.


METHODS
An 8-week double-blind clinical trial was performed in which 20 EOAs were randomized to receive ondansetron (4 microg/kg twice a day) and naltrexone (25 mg twice a day) or placebo as an adjunct to weekly standardized cognitive behavioral therapy. Serum CDT was assessed at weeks 0 (baseline), 4, and 8.


RESULTS
Log serum CDT was significantly lower in the ondansetron and naltrexone 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; effect size = 0.41], and an interaction between group and visit [F(1,16) = 27.54, 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 drinking data and demonstrated that the medication combination is an effective treatment for EOAs.
Ait-Daoud
N
N
Department of Psychiatry and the Southwest Texas Addiction Research and Technology (START) Center, University of Texas Health Science Center at San Antonio, San Antonio 78229-3900, Texas, USA. tiouririne@uthscsa.edu
Johnson
B A
BA
Javors
M
M
Roache
J D
JD
Zanca
N A
NA
D000328:Adult; D000428:Alcohol Drinking / Q000097:blood*; D000437:Alcoholism / Q000188:drug therapy*; D015415:Biomarkers / Q000097:blood*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D009271:Naltrexone / Q000008:administration & dosage* / Q000627:therapeutic use; D009292:Narcotic Antagonists / Q000008:administration & dosage / Q000627:therapeutic use; D017294:Ondansetron / Q000008:administration & dosage* / Q000627:therapeutic use; D010919:Placebos; D012702:Serotonin Antagonists / Q000008:administration & dosage / Q000627:therapeutic use; D014168:Transferrin / Q000031:analogs & derivatives / Q000032:analysis*
D015415:Biomarkers; D009292:Narcotic Antagonists; D010919:Placebos; D012702:Serotonin Antagonists; D014168:Transferrin; C056759:carbohydrate-deficient transferrin; D017294:Ondansetron; D009271:Naltrexone