Cognitive and gut health interventions for alcohol users with HIV
Cognitive and Inflammation Targeted Gut-brain Interventions in Alcohol; Probiotics, Alcohol, Transcutaneous Vagus Nerve Stimulation, and HIV Study
This study tests two different approaches to help people with HIV who drink alcohol by using a device to stimulate the nervous system and a probiotic to improve gut health and brain function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 35 Years to 70 Years |
| Sex | All |
| Sponsor | University of Florida Academic / other |
| Locations | 1 site (Coral Gables, Florida) |
| Trial ID | NCT05090267 on ClinicalTrials.gov |
What this trial studies
This project evaluates two interventions aimed at improving cognition and gut health in individuals with HIV who consume alcohol. One intervention involves using a portable Transcutaneous Vagus Nerve Stimulator (tVNS) to stimulate the autonomic nervous system, potentially reducing inflammation and enhancing cognitive function. The second intervention is a probiotic supplement designed to restore healthy gut bacteria in participants experiencing dysbiosis. The study employs a hybrid trial design to assess the effectiveness of these interventions.
Who should consider this trial
Good fit: Ideal candidates are English or Spanish speaking adults aged 35-70 with cognitive impairment and a history of alcohol use.
Not a fit: Patients with major psychiatric illnesses or those who have recently undergone intensive treatment for addictive behaviors may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cognitive function and gut health for individuals with HIV who consume alcohol.
How similar studies have performed: While the specific combination of interventions is novel, similar approaches targeting the gut-brain axis have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 35-70 years * English or Spanish speaking * Alcohol users * Cognitive impairment * Current CD4\>350 Exclusion Criteria: * Diagnosed major psychiatric illness * Consumption of over 300 drinks in the past 30 days * Recent opioid use * Lifetime history of medically-assisted alcohol detoxification * Inpatient or intensive treatment for addictive behaviors in the past 12 months * MRI contraindications * Current antibiotic treatment * Current probiotic use * Physical impairment precluding motor response or lying still.
Where this trial is running
Coral Gables, Florida
- University of Miami — Coral Gables, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Eric Porges, PhD — University of Florida
- Study coordinator: Emily Carter
- Email: em.carter@phhp.ufl.edu
- Phone: 352-294-5837
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.