RECRUITINGINTERVENTIONAL

The Path Study: Cognitive and Inflammation Targeted Gut-brain Interventions in Alcohol; Probiotics, Alcohol, Transcutaneous Vagus Nerve Stimulation, and HIV Study

Cognitive and Inflammation Targeted Gut-brain Interventions in Alcohol; Probiotics, Alcohol, Transcutaneous Vagus Nerve Stimulation, and HIV Study

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Age 35-70 years - English or Spanish speaking - Alcohol users - Cognitive impairment - Current CD4\>350 Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DIETARY_SUPPLEMENT

Probiotic Supplement

Participants will take a probiotic supplement or placebo for 90 days.

DEVICE

Transcutaneous Vagal Nerve Stimulation (tVNS)

Participants will use a non-invasive stimulator 1 hour daily for 30 days. This stimulator is placed around the ear similar to headphones and produces a very mile electric current. This wellness device is safe to use and painless. Some describe the sensation to be a slight tingle up to a small itch.

Locations (1)

University of Miami

Coral Gables, Florida, United States