The Path Study: Cognitive and Inflammation Targeted Gut-brain Interventions in Alcohol; Probiotics, Alcohol, Transcutaneous Vagus Nerve Stimulation, and HIV Study
Launched by UNIVERSITY OF FLORIDA · Oct 11, 2021
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
The Path Study is a clinical trial designed to explore two different treatments aimed at improving brain function and gut health in people who drink alcohol and have cognitive difficulties. One treatment involves a small device called a Transcutaneous Vagus Nerve Stimulator (tVNS) that gently stimulates a nerve in the neck, which may help reduce inflammation in the body and improve thinking skills. The other treatment is a probiotic supplement, which is meant to restore healthy bacteria in the gut that might be disrupted by alcohol use and HIV.
To participate in this study, you need to be between 35 and 70 years old, speak either English or Spanish, and currently use alcohol. It's important that you have some level of cognitive impairment and a certain level of immune health (with a CD4 count greater than 350). However, if you have a serious mental health condition, have consumed a lot of alcohol recently, or have certain medical issues, you may not be eligible. Participants can expect to receive either one or both of the treatments and will help researchers understand how these interventions can improve health. This study is currently looking for volunteers, so if you meet the criteria and are interested, it could be a great opportunity to contribute to important research.
Gender
ALL
Eligibility criteria
- 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.
About University Of Florida
The University of Florida, a leading research institution, is dedicated to advancing healthcare through innovative clinical trials. With a focus on enhancing patient outcomes and exploring new therapeutic avenues, the university leverages its extensive resources, interdisciplinary expertise, and state-of-the-art facilities to conduct rigorous research across a variety of medical fields. Committed to ethical standards and patient safety, the University of Florida fosters collaboration among researchers, healthcare professionals, and community stakeholders to translate scientific discoveries into impactful clinical applications.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Coral Gables, Florida, United States
Patients applied
Trial Officials
Eric Porges, PhD
Principal Investigator
University of Florida
Robert L Cook, MD
Study Director
University of Florida
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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