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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-70
SponsorUniversity of Florida

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

80 Participants
are divided into 2 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