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Ondansetron, Alcohol Use, and Alcohol-Related Symptoms In HIV+ Persons

NCT01254877 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 357

Last updated 2018-04-17

Study results available
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Summary

The proposed randomized clinical trial will investigate a novel pharmacotherapy for hazardous drinking, HIV-infected men and women, using the serotonin receptor (5-HT3) antagonist ondansetron. The investigators predict that participants who are treated with active doses of ondansetron will reduce their drinking more and show better HIV treatment participation and progress compared to participants who are treated with placebo. This study will provide important new safety and efficacy results on drinking and HIV outcomes following alcohol pharmacotherapy in HIV-infected persons.

Conditions

  • Alcohol Abuse
  • Alcohol Dependence

Interventions

DRUG

ondansetron

ondansetron 0.2 mg bid, oral preparation, 16 weeks

DRUG

placebo ondansetron

Matching placebo will be prepared using a colorless strawberry syrup, simple syrup and flat Schweppes tonic water.

DRUG

Ondansetron

Ondansetron 0.8 mg bid, oral preparation, 16 weeks duration

Sponsors & Collaborators

Principal Investigators

  • Mary E McCaul, Ph.D. · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2017-01-31
Completion
2017-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT01254877 on ClinicalTrials.gov