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
University of Florida
80 participants
Jun 1, 2022
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- Age 35-70 years
- English or Spanish speaking
- Alcohol users
- Cognitive impairment
- Current CD4\>350
Exclusion Criteria9
- 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
Participants will take a probiotic supplement or placebo for 90 days.
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05090267