Reducing Heavy Drinking to Optimize HIV/AIDS Treatment and Prevention
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- HAART Adherence
研究概览
简要总结
This is a double-blind placebo-controlled study to evaluate the effect of Naltrexone (NTX) and counseling on highly active antiretroviral treatment (HAART) medication adherence in a cohort of HIV-infected patients who report heavy drinking, or meet criteria for alcohol abuse and/or dependence, and inadequate (< 95%) HAART adherence. All patients will receive a behavioral intervention, termed Medical Management/Medication Coaching or MM/MC. MM/MC incorporates the behavioral platform Medical Management (MM) from the National Institute on Alcohol Abuse and Alcoholism (NIAAA)-funded COMBINE Study to reduce heavy alcohol use with Medication Coaching (MC), a manualized treatment designed to improve HAART medication adherence in HIV-infected patients with substance use disorders.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Be HIV-infected.
- •Currently be prescribed HAART medication or be eligible to receive HAART medication.
- •Report less than 95% adherence to their HAART medication.
- •Report heavy drinking 4 or more times in the past 4 weeks, or meet current criteria for alcohol abuse or dependence. Heavy drinking is defined as 4 or more drinks for women and 5 or more drinks for men on one occasion.
- •Be at least 18 years old.
- •Be able to understand English and provide informed consent.
排除标准
- •Be psychotic or severely psychiatrically disabled.
- •Be currently enrolled in formal treatment for alcohol (excluding self-help, e.g. Alcoholics Anonymous)
- •Have medical conditions that would preclude completing or be of harm during the course of the study.
- •Have laboratory or clinical evidence of significant liver dysfunction (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 5 times the upper limit of the normal range) or cirrhosis with a Child-Pugh classification greater than A or B.
- •Have a known contraindication to NTX therapy (e.g. requiring opioid medication for pain).
- •Be pregnant, nursing or unable to use an effective method of birth control (women).
研究组 & 干预措施
Placebo + MM/MC
Placebo plus Medical Management/Medication Coaching
干预措施: Placebo + Medication Management/Medication Coaching (Other)
NTX + MM/MC
Naltrexone + Medical Management/Medication Coaching
干预措施: Naltrexone (Drug)
结局指标
主要结局
HAART Adherence
时间窗: One year
The intent of this outcome is to compare the efficacy of NTX +MM/MC versus placebo +MM/MC on adherence to HAART. It is hypothesized that NTX +MM/MC will lead to improved adherence to HAART when compared to placebo + MM/MC.
次要结局
- Heavy Drinking Days(One year)