NCT02354703

Pharmacogenetic Study of Ondansetron in Alcohol Use Disorder

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2 Pharmacogenetic Study of Ondansetron in Alcohol Use Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 293 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The primary study objective is to determine the efficacy of ondansetron (0.33 mg twice daily) administered orally for a period of 16 weeks in reducing risky drinking among currently drinking subjects with alcohol use disorder who have selected genotypes at the serotonin transporter and receptor genes. The secondary objective is to assess the safety and tolerability of ondansetron in subjects with alcohol use disorder who have selected genotypes at the serotonin transporter and receptor genes.

Detailed description

Alcohol use disorder (AUD) is a heterogeneous and chronic relapsing disorder that includes both acute (binge drinking) and chronic (frequent heavy drinking) dimensions. Perhaps because of this heterogeneity, the therapeutic effect size of the approved medicines for the treatment of AUD has been small. In an effort to overcome the heterogeneity of response to a particular medication, recent studies have instituted a personalized approach to therapy. Major breakthroughs in pharmacogenetics have made it possible to identify discrete subgroups of the AUD population according to genetic profiles in order to target the subjects who are most likely to respond to treatment with a particular agent. In addition, genetic variation contributing to the risk of alcohol dependence may be differentially associated with treatment response Thus a successful personalized medicinal approach should ensure that targeted subgroups achieve an optimal treatment response with high predictability. Such an approach holds the potential to identify not only robust responders to treatment but also those who might have minimal or modest adverse effects from the putative therapeutic medication. From a practical clinical standpoint, a personalized medicine approach starts with a genetic screen to identify the "right" subject, who can then be treated with the appropriate medication, with a high probability of a positive treatment outcome and, therefore, a substantial impact on public health.

Conditions

• Alcohol Use Disorder

Interventions

Type	Name	Description
DRUG	Ondansetron	Ondansetron (0.33 mg) bid+ BBCET counseling
DRUG	Placebo	Placebo + BBCET counseling

Timeline

• Start date: 2015-08-01
• Primary completion: 2020-03-31
• Completion: 2020-03-31
• First posted: 2015-02-03
• Last updated: 2022-01-14
• Results posted: 2022-01-14

Locations

3 sites across 1 country: United States