ARCH II Study (Alcohol Research Center on HIV Study II)

University of Florida14 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Interventions

Motivational InterviewingBEHAVIORAL

A type of counseling aimed at reducing consumption of alcohol.

Questionnaire assessmentOTHER

Several different types of questionnaires will be fill out by the participants.

Neurocognitive assessmentsOTHER

Several different types of neurocognitive assessment will be performed.

Blood specimensOTHER

Blood specimens will be used to measure the immunological, virologic, and hepatic status, as well as other biomarkers.

Eligibility

Sex: ALLMin age: 25 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * HIV-infected; * English speaking; * Physically mobile; * Willingness to participate in the Motivational Interviewing (MI) to reduce ETOH consumption. Exclusion Criteria: * 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.

Outcomes

Primary Outcomes

FMRI images will be performed for changes in the brain between the groups

Cerebral metabolite abnormalities

Time frame: Baseline and 6 month follow-up

Secondary Outcomes

Structured Clinical Interview for Diagnostic and Statistical Manual (DSM)-IV (SCID)

A structured interview given to participants in order to assess current and past alcohol use and dependence

Time frame: Baseline

Lifetime Alcohol and Drug Use History

This interview will be conducted at baseline to gather information about age of onset of alcohol use, period of heaviest drinking, most drinks consumed on a single day, and number of drug classes used lifetime.

Time frame: Baseline

Kreek-McHugh-Schluger-Kellogg (KMSK) Scale

Developed as a research measure of drug use severity in accordance with DSM-IV criteria, the KMSK is reliable and valid, quantifying frequency, duration, and amount of individual drug use.