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

Information source: Johns Hopkins University
ClinicalTrials.gov processed this data on November 27, 2014
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Alcohol Abuse; Alcohol Dependence

Intervention: ondansetron (Drug); placebo ondansetron (Drug); Ondansetron (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Johns Hopkins University

Official(s) and/or principal investigator(s):
Mary E McCaul, Ph.D., Principal Investigator, Affiliation: Johns Hopkins University

Overall contact:
Mary E McCaul, Ph.D., Phone: (410)502-2723, Email: mmccaul1@jhmi.edu

Summary

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.

Clinical Details

Official title: Ondansetron Pharmacotherapy for Hazardous Drinking in HIV+, African-American Women

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Primary outcome:

number of drinks per drinking day

Total number of days abstinent from alcohol

Secondary outcome:

medication safety

Number of subjects who discontinue due to side effects

Alcohol-related problems

HIV medication persistence

HIV risk behaviors

Quality of life

Detailed description: 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 from the Baltimore/Washington area. 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Mary E McCaul, Ph.D., Phone: (410)502-2723, Email: mmccaul1@jhmi.edu

Johns Hopkins Hospital, Baltimore, Maryland 21205, United States; Recruiting
Mary E McCaul, Ph.D., Principal Investigator
Additional Information

Related publications:

Johnson BA, Roache JD, Javors MA, DiClemente CC, Cloninger CR, Prihoda TJ, Bordnick PS, Ait-Daoud N, Hensler J. Ondansetron for reduction of drinking among biologically predisposed alcoholic patients: A randomized controlled trial. JAMA. 2000 Aug 23-30;284(8):963-71.

Starting date: December 2010
Last updated: August 28, 2013

Page last updated: November 27, 2014

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