View Clinical Trial (Medical Research Study)
Ondansetron Pharmacotherapy for Hazardous Drinking in HIV+, African-American Women
| City: |
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Baltimore |
| State: |
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Maryland |
| Zip Code: |
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21205 |
| Conditions: |
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Alcohol Abuse - Alcohol Dependence |
| Purpose: |
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The proposed randomized clinical trial will investigate a novel pharmacotherapy for
hazardous drinking, HIV-infected men and women, using the 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.
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| Study Summary: |
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Hazardous drinking is particularly harmful in HIV-infected persons. It impairs the immune
system, accelerates HIV disease progression, slows initiation of ART and decreases
adherence. Thus, the development of effective alcohol treatments for this clinical
population is particularly important. The investigators are proposing to investigate the
effectiveness of ondansetron pharmacotherapy for the treatment of hazardous alcohol use and
alcohol abuse/dependence among HIV-infected patients. Ondansetron, a 5-HT3 antagonist, will
be studied for several reasons: 1) evidence of effectiveness in persons who want to cut-down
or reduce their drinking and who are not abstinent at medication initiation; 2)
moderate-to-strong effects among early onset problem drinkers, a characteristic that is over
represented in our clinic patients; 3) a very mild side-effect profile, making it an ideal
pharmacotherapy candidate in patients who are often receiving multiple other medications
with significant side-effects; and 4) its primary indication is for treatment of nausea, a
common side-effect of ARV medications.
The proposed study is a placebo-controlled, randomized clinical trial of ondansetron for the
treatment of hazardous drinking and alcohol use disorders among HIV-infected patients
recruited in a hospital-based HIV outpatient clinic. Participants will be genotyped for a
functional polymorphism of the serotonin transporter gene. They will be randomized to one
of three treatment groups: placebo, low dose ondansetron (0.2 mg bid) and moderate dose
ondansetron (0.8 mg bid). All subjects will undergo 16 weeks of pharmacotherapy in
combination with medication management, and will be followed for 3 and 6 months after
medication has ended.
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| Criteria: |
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Inclusion Criteria:
- Subjects will be at least 18 years old and HIV-infected
- All subjects will be actively drinking at hazardous levels (1) AUDIT score => 4 for
women or =>8 for men, or 2) => 2 binge drinking episodes/month, or 3) >7 drinks/week
for women or >14 drinks/week for men)
Exclusion Criteria:
- LFTs > 5 X normal
- Magnesium or potassium > 3 X normal
- Qtc => .460 and or a family history of LQT
- Inability to read and comprehend English
- Actively psychotic or other severe mental health symptoms that would prevent
appropriate participation
- Current enrollment in alcoholism treatment program
- Pregnancy; Ondansetron is currently a category B drug. While animal data have not
identified any harmful effects to mother or fetus, there have not been adequate human
controlled trials to recommend routine use in this population
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| NCT ID: |
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NCT01254877 |
| Primary Contact: |
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Principal Investigator
Mary E McCaul, Ph.D.
Johns Hopkins University
Mary E McCaul, Ph.D.
Phone: (410)502-2723
Email: mmccaul1@jhmi.edu
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| Backup Contact: |
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Email: gchande1@jhmi.edu
Geetanjali Chander, M.D.
Phone: (443) 287-2030
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| Location Contact: |
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Baltimore, Maryland 21205
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 23, 2013 |
| Modifications to this listing: |
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