Ondansetron, Alcohol Use, and Alcohol-Related Symptoms In HIV+ Persons
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.
Drug: placebo ondansetron
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
|Official Title:||Ondansetron Pharmacotherapy for Hazardous Drinking in HIV+, African-American Women|
- number of drinks per drinking day [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]The Time-line Follow-back (Sobell, Sobell, Leo & Cancilla, 1988) is used to obtain the primary dependent measure. Alcohol use is assessed biweekly and quantified over the 16-week medication period
- Total number of days abstinent from alcohol [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]The Time-line Follow-back (Sobell, Sobell, Leo & Cancilla, 1988) is used to obtain this secondary dependent measure. Alcohol use will be assessed biweekly and quantified over the 16-week medication period. Total number of days abstinent will be calculated as the number of abstinent days divided by the number of days elapsed (adjusted for days in confinement (e.g., hospitalization; jail)).
- medication safety [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]Medication side-effects and adverse events will be measured using the SAFTEE.
- Number of subjects who discontinue due to side effects [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]The investigators will count the number of subjects who discontinue medication during the 16-week intervention period due to complaints of side effects.
- Alcohol-related problems [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]The investigators will measure alcohol-related problems using the SIP-2R, a widely used and well validated instrument.
- HIV medication persistence [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]The investigators will obtain patient self reports of HIV medication persistence as well as a visual analog scale of % persistence.
- HIV risk behaviors [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]Risk behaviors will be measured based on self report
- Quality of life [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]Quality of life will be measured based on subject self report.
|Study Start Date:||December 2010|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo - sugar pill
Placebo is an oral preparation made to appear and taste like the active drug preparation.
Drug: placebo ondansetron
Matching placebo will be prepared using a colorless strawberry syrup, simple syrup and flat Schweppes tonic water.
|Experimental: low dose ondansetron (0.2 mg bid)||
ondansetron 0.2 mg bid, oral preparation, 16 weeks
|Experimental: moderate dose ondansetron (0.8 mg bid)||
Ondansetron 0.8 mg bid, oral preparation, 16 weeks duration
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01254877
|Contact: Mary E McCaul, Ph.D.||(410)firstname.lastname@example.org|
|Contact: Geetanjali Chander, M.D.||(443) email@example.com|
|United States, Maryland|
|Johns Hopkins Hospital||Recruiting|
|Baltimore, Maryland, United States, 21205|
|Principal Investigator: Mary E McCaul, Ph.D.|
|Principal Investigator:||Mary E McCaul, Ph.D.||Johns Hopkins University|