Status:
COMPLETED
30-to-90 Day Challenge: Effects of Alcohol Cessation on Health Outcomes
Lead Sponsor:
University of Florida
Collaborating Sponsors:
University of Miami
Florida International University
Conditions:
Alcohol Drinking
Chronic Inflammation
Eligibility:
All Genders
50-75 years
Phase:
NA
Brief Summary
The objective for this project is to determine whether how certain behavioral and health functions change in persons with heavy drinking when they stop (or reduce) drinking for 30 days, and whether ch...
Detailed Description
This proposed study continues a line of research by Doctors Cohen, Cook, Kahler, and colleagues on heavy alcohol use, HIV-associated brain dysfunction, and long-term HIV outcomes. The study will build...
Eligibility Criteria
Inclusion
- Men and women;
- Age: 50-75 yrs.;
- 140 participants will have confirmed HIV (confirmed via baseline bloodwork) and 40 participants will be HIV negative
- English speaking (will have protocol ready in Spanish in 2017);
- Physically mobile;
- Willing to participate in CM to reduce alcohol consumption, and to wear the alcohol biosensor for at least 30 days. All participants will be current, heavy drinkers (\>=14 drinks/week women, \>=21 drinks/week men), confirmed by baseline timeline follow-back, and by having evidence of at least 3 drinking episodes on the alcohol biosensor prior to baseline). Must blow a "zero" on breathalyzer at time of informed consent
Exclusion
- Neurological disorders (e.g., dementia, stroke, seizures, traumatic brain injury).
- Evidence of dementia (MOCA \< 17).
- Past opportunistic brain infection
- Major psychiatric illness (schizophrenia, intractable affective disorder, current substance dependence diagnosis).
- Current major psychiatric disturbance, including severe major depression.
- Unstable medical conditions (e.g., cancer).
- MRI contraindications (e.g., pregnancy, severe claustrophobia, metal implants).
- Physical impairment precluding motor response or lying still.
- Significant history of alcohol withdrawal as indicated by an Alcohol Withdrawal Symptom Checklist score ≥ 23 (within past year).
- Unable to correctly answer a set of questions that demonstrate understanding of key aspects of the study, including the voluntary nature of the study, the purpose of the study, what participants are being asked to do as part of the study, and what are the risks related to participating in the study.
Key Trial Info
Start Date :
December 11 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2024
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT03353701
Start Date
December 11 2017
End Date
January 1 2024
Last Update
September 3 2024
Active Locations (1)
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1
University of Miami
Miami, Florida, United States, 33136