Ondansetron Pharmacotherapy for Hazardous Drinking in HIV+, African-American Women
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 357
- 试验地点
- 1
- 主要终点
- Number of Alcoholic Containing Drinks Per Drinking Day
研究概览
简要总结
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.
详细描述
Hazardous drinking is particularly harmful in HIV-infected persons. It impairs the immune system, accelerates HIV disease progression, slows initiation of antiretroviral therapy (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 antiretroviral (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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Liver Function Tests (LFTs) > 5 X normal
- •Magnesium or potassium > 3 X normal
- •Qtc => .460 and or a family history of long QT syndrome (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
研究组 & 干预措施
Placebo Ondansetron - sugar pill
Placebo is an oral preparation made to appear and taste like the active drug preparation.
干预措施: placebo ondansetron (Drug)
low dose ondansetron (0.2 mg bid)
干预措施: Ondansetron (Drug)
moderate dose ondansetron (0.8 mg bid)
干预措施: Ondansetron (Drug)
结局指标
主要结局
Number of Alcoholic Containing Drinks Per Drinking Day
时间窗: 16 weeks
The Time-line Follow-back (TLFB; Sobell, Sobell, Leo \& Cancilla, 1988) is conducted as an interview administered by trained and certified research staff. The interview obtains participant self-reports of daily drinking, including number and type of alcoholic beverages. These data are used to quantify an individual's drinking pattern including the number of drinks per drinking day and drinking frequency. The TLFB was completed biweekly and quantified over the 16-week medication period
Number of Days/Week Abstinent From Alcohol
时间窗: 16 weeks
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. Number of days/week abstinent from alcohol is calculated as the number of abstinent days divided by the number of study medication days (adjusted for days in confinement (e.g., hospitalization; jail)) and multiplied by 7.
次要结局
- Alcohol-related Problems(16 weeks)
- HIV Medication Adherence(16 weeks)
- Medication Safety(16 weeks)
- Number of Subjects Who Discontinue Due to Side Effects(16 weeks)