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.
Eligibility criteria
Qualifiers
Age 35-70 years
English or Spanish speaking
Alcohol users
Cognitive impairment
Disqualifiers
Diagnosed major psychiatric illness
Consumption of over 300 drinks in the past 30 days
Recent opioid use
Lifetime history of medically-assisted alcohol detoxification
Trial design
Treatments tested in this trial
- Probiotic Supplement
- Transcutaneous Vagal Nerve Stimulation (tVNS)
Treatment groups
Sponsors and collaborators
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