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Pharmacogenetic Study of Ondansetron in Alcohol Use Disorder

NCT02354703 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 293

Last updated 2022-01-14

Study results available
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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.

Conditions

Interventions

DRUG

Ondansetron

Ondansetron (0.33 mg) bid+ BBCET counseling

DRUG

Placebo

Placebo + BBCET counseling

Sponsors & Collaborators

Principal Investigators

  • David A Gorelick, MD, PhD · University of Maryland, Baltimore

  • Henry R Kranzler, MD · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2020-03-31
Completion
2020-03-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02354703 on ClinicalTrials.gov