Alcohol and HIV: Biobehavioral Interactions and Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 4
- 主要终点
- FMRI images will be performed for changes in the brain between the groups
研究概览
简要总结
This study is being done to learn about the interaction of alcohol consumption and HIV on brain function. The proposed study will have two broad objectives. The first is to incorporate functional neuroimaging (FMRI) approaches, along with additional Magnetic Resonance Spectroscopy (MRS) methods that will enable a delineation in both functional and cerebral metabolic disturbances affecting specific functional brain systems that are associated with the interaction of ethanol (ETOH) consumption on Human Immunodeficiency Virus (HIV)-associated brain dysfunction. Recent data indicate that HIV infected patients with heavy ETOH consumption have FMRI abnormalities and exhibit alterations on other neuroimaging measures compared to moderate drinkers and people who do not drink at all. The second objective is to examine the extent to which reductions in ETOH consumption among heavy drinkers with HIV infection result from a motivational intervention. The findings from this study will provide important information on how heavy ETOH and HIV interact to affect the brain functional responsiveness, and the extent of improvement that might be gained by reducing heavy ETOH use.
详细描述
In this research study, participants will be randomized (much like flipping a coin) by a computer program to either no counseling or FMRI during the baseline visit in the second session for this visit.
Each time point (baseline, 3 months and 9 months) consists of 2 participant sessions. Session 1) at baseline is for the purposes of recruiting and determining if participants meet study criteria; during all visits, study criteria are reviewed to ensure that enrolled participants are still eligible. After determining eligibility, study information is explained by the research assistant and consent is then obtained. Additional psychiatric and substance use assessment and neurological and will be performed. Blood and urine specimens will be obtained and sent to lab for measurement of immunological, virologic, and hepatic status and other biomarkers. The remainder of the blood specimens will be frozen and banked for future analyses. All blood specimens banks for future analyses will be deidentified. A neurocognitive assessment performed by a research assistant. The duration will be approximately 120 minutes. Session 2) will occur within one week of visit one. It will consist of an MRI scan lasting approximately 50 minutes. Functional imaging will be conducted during this MRI time. All participants will undergo all procedures at baseline, and three and nine months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •HIV-infected;
- •English speaking;
- •Physically mobile;
- •Willingness to participate in the Motivational Interviewing (MI) to reduce ETOH consumption.
排除标准
- •Neurological disorders;
- •Evidence of dementia;
- •Past opportunistic brain infection;
- •Major psychiatric illness;
- •Current major psychiatric disturbance;
- •Unstable medical conditions (cancer);
- •MRI contraindications (e.g., pregnancy, claustrophobia, metal implants);
- •Physical impairment precluding motor response or lying still.
结局指标
主要结局
FMRI images will be performed for changes in the brain between the groups
时间窗: Baseline and 6 month follow-up
Cerebral metabolite abnormalities
次要结局
- Kreek-McHugh-Schluger-Kellogg (KMSK) Scale(Baseline, 3-month, 6-month, and 12-month follow-ups.)
- Stroop Task(Baseline, 3-month, 6-month, and 12-month follow-ups.)
- Structured Clinical Interview for Diagnostic and Statistical Manual (DSM)-IV (SCID)(Baseline)
- Lifetime Alcohol and Drug Use History(Baseline)
- Timeline Followback (TLFB)(Baseline, 3-month, 6-month, and 12-month follow-ups.)
- Short Inventory of Problems (SIP)(Baseline, 3-month, 6-month, and 12-month follow-ups.)
- Urine Drug Screen(Baseline, 3-month, 6-month, and 12-month follow-ups.)
- Epworth Sleepiness Scale (ESS)(Baseline, 3-month, 6-month, and 12-month follow-ups.)
- Grooved Pegboard(Baseline, 3-month, 6-month, and 12-month follow-ups.)
- Verbal Fluency(Baseline, 3-month, 6-month, and 12-month follow-ups.)
- Animal Fluency(Baseline, 3-month, 6-month, and 12-month follow-ups.)
- The Wechsler Test of Adult Reading (WTAR)(Baseline, 3-month, 6-month, and 12-month follow-ups.)
- California Computerized Assessment Package (CalCAP)(Baseline, 3-month, 6-month, and 12-month follow-ups.)
- Center for Epidemiological Studies-Depression Scale (CES-D)(Baseline, 3-month, 6-month, and 12-month follow-ups.)
- Beck Anxiety Inventory(Baseline, 3-month, 6-month, and 12-month follow-ups.)
- Early Life Stress Questionnaire (ELSQ)(Baseline)
- The Frontal System Behavioral Scale (FrSBe)(Baseline, 3-month, 6-month, and 12-month follow-ups.)
- Medical Outcomes Study HIV Health Survey (MOS-HIV)(Baseline, 3-month, 6-month, and 12-month follow-ups.)
- Montreal Cognitive Assessment (MoCA)(Baseline, 3-month, 6-month, and 12-month follow-ups.)
- Hopkins Verelan Learning Test Revised (HVLT-R)(Baseline, 3-month, 6-month, and 12-month follow-ups.)
- Brief Visuospatial Memory Test Revised (BVMT-R)(Baseline, 3-month, 6-month, and 12-month follow-ups.)
- Paced Auditory Serial Addition Test (PASAT-1)(Baseline, 3-month, 6-month, and 12-month follow-ups.)
- WAIS-3 Letter Number Sequencing(Baseline, 3-month, 6-month, and 12-month follow-ups.)
- WAIS-3 Symbol Search(Baseline, 3-month, 6-month, and 12-month follow-ups.)
- Boston Naming Test(Baseline, 3-month, 6-month, and 12-month follow-ups.)
- Adaptive Rate Continuous Performance Test (ARCPT)(Baseline, 3-month, 6-month, and 12-month follow-ups.)
- WAIS-3 Digit Symbol(Baseline, 3-month, 6-month, and 12-month follow-ups.)
- Trail Making(Baseline, 3-month, 6-month, and 12-month follow-ups.)