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Pharmacotherapy for HIV+ Stimulant Dependent Individuals

NCT00599573 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2010-04-14

No results posted yet for this study

Summary

The hypotheses of this study are:

1. Ondansetron will show a decrease in cocaine use from baseline in individuals with HIV who are cocaine using.
2. Ondansetron will show a decrease in cravings from baseline in individuals with HIV who are cocaine using.

After informed consent and screening, HIV infected individuals who are cocaine dependent and qualify for the study will be offered ondansetron 4mg BID for six weeks in an open label format 4mg BID has been found to have efficacy compared to placebo. At screening and then at each visit, they will be asked to provide urine and a drug of abuse screen will be conducted to assess for cocaine. They will be asked to detail their recent cocaine use in the last month and then will be given a visual analog scale to assess their craving for cocaine. They will be asked to return weekly for 6 weeks to receive a week's supply of ondansetron and to give a urine sample that will test for cocaine. They will fill out a time line follow back for the past week and asked to assess their craving for cocaine on a visual analog scale.

Conditions

  • HIV Infections
  • Cocaine Dependence

Interventions

DRUG

ondansetron

Ondansetron 4mg BID for six weeks

Sponsors & Collaborators

  • University of Virginia

    lead OTHER

Principal Investigators

  • Gabrielle Marzani-Nissen, MD · University of Virginia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2010-07-31
Completion
2010-12-31

Countries

  • United States

Study Locations

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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 NCT00599573 on ClinicalTrials.gov