NCT05090267NARecruiting
The Path Study: Cognitive and Inflammation Targeted Gut-brain Interventions in Alcohol; Probiotics, Alcohol, Transcutaneous Vagus Nerve Stimulation, and HIV Study
University of Florida
Start Date
6/1/2022
Completion Date
9/30/2026
Summary
This project uses a hybrid trial design to evaluate two biomedical interventions targeting the gut-brain axis. One intervention is portable Transcutaneous Vagus Nerve Stimulator, tVNS, that is hypothesized to stimulate the autonomic nervous system, resulting in decreased inflammation and improved cognition. The second intervention is a probiotic supplement intended to replace gut bacteria that are associated with dysbiosis in persons with HIV and alcohol consumption.
Eligibility Criteria
Age Range: 35 years to 70 years
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.
Interventions
DIETARY_SUPPLEMENT
Probiotic Supplement
DEVICE
Transcutaneous Vagal Nerve Stimulation (tVNS)
Conditions
CognitionGut Microbiome
Locations
University of Miami
Coral Gables, Florida 33146
United States