Pharmacogenetic Study of Ondansetron in Alcohol Use Disorder

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02354703
Study type	Interventional
Source	University of Maryland, Baltimore
Contact
Status	Completed
Phase	Phase 2
Start date	August 2015
Completion date	March 31, 2020

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.