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

NCT02563574 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2022-04-04

No results posted yet for this study

Summary

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.

Conditions

  • Alcohol Consumption
  • HIV
  • Motivation

Interventions

BEHAVIORAL

Motivational Interviewing

A type of counseling aimed at reducing consumption of alcohol.

OTHER

Questionnaire assessment

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

OTHER

Neurocognitive assessments

Several different types of neurocognitive assessment will be performed.

OTHER

Blood specimens

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

Sponsors & Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    collaborator NIH
  • Brown University

    collaborator OTHER
  • University of Florida

    lead OTHER

Principal Investigators

  • Ron Cohen, Ph.D · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2021-12-16
Completion
2021-12-16

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02563574 on ClinicalTrials.gov