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.
Age 35-70 years
English or Spanish speaking
Alcohol users
Cognitive impairment
Diagnosed major psychiatric illness
Consumption of over 300 drinks in the past 30 days
Recent opioid use
Lifetime history of medically-assisted alcohol detoxification
Factorial
Probiotic Supplement
Dietary supplementParticipants will take a probiotic supplement or placebo for 90 days.
Transcutaneous Vagal Nerve Stimulation (tVNS)
DeviceParticipants 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.
Improved cognition from day 1 to day 90
Various indices of cognition will be measured using standard neuropsychological tests and neuroimaging at multiple time points and examined for change within subjects.
Reduction of dysbiosis from day 1 to day 90
The gut microbiome will be analyzed through stool samples to measure for changes in biodiversity including an increase in beneficial bacteria.
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University of Florida
Lead sponsor
University of Miami
Collaborator
University of Louisville
Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
Exegi Pharma, LLC
Collaborator
Soterix Medical
Collaborator
