Screening
Jenny or Dr. Paulus conduct comprehensive eligibility assessment including medical history, diagnostic evaluations, and informed consent discussion.
Clinical Research Services in Ponte Vedra Beach, FL
Advancing Mental Health Treatment
Director:Jenny Piraino, MS (Neuroscience)
Research Focus:Psychedelic & neuromodulation therapies
Experience:13+ years neuroscience & clinical research
Our Mission
From Discovery to Clinical Application
Bridging Research & Patient Care
Traditional mental health care often relies on long-established treatments that may not work for every patient. At the same time, emerging therapies such as psychedelic-assisted treatments, neuromodulation, and precision psychiatry are still being evaluated and are not yet widely accessible.
West Eastern Health integrates clinical research within a real-world care setting. Our team investigates emerging therapies under structured protocols designed to evaluate safety, feasibility, and effectiveness. Patients may have the opportunity to participate in research studies that provide access to investigational treatments while contributing to ongoing scientific understanding.
What Are Clinical Research Services?
Evidence-Based Treatment Innovation
Clinical research services include the design, implementation, and evaluation of studies that investigate new or evolving approaches to mental health care. At West Eastern Health, research efforts focus on psychedelic-assisted therapies, neuromodulation, and integrative approaches for complex or treatment-resistant conditions. Study types may include observational research, early-phase clinical trials, and translational research that connects neuroscience findings with clinical application.
Our approach combines Jenny Piraino’s experience in clinical trial operations with Dr. Paulus’s background in Phase I/II trial design and translational oncology. All studies follow regulatory requirements and institutional review board oversight, with participant safety as the primary priority.
Research Participation Timeline
Screening Visit
1-2 hours (eligibility assessment)
Study Duration
Varies by protocol (often several weeks to months)
First Assessment
Baseline measures collected at enrollment
Follow-Up
Protocol-specific intervals (weekly to monthly)
Benefits of Clinical Research
Access & Contribution
- 01
Early Access
Opportunity to access investigational treatments not yet widely available
- 02
Expert Monitoring
Close oversight by experienced research clinicians throughout the study
- 03
Advance Science
Contribute to research that may improve future treatment options
- 04
Study-Related Care
Many studies include study-related treatment and assessments at no cost
- 05
Comprehensive Assessment
Detailed evaluations and structured follow-up during participation
Types of Clinical Research Studies
Understanding Study Designs
| Study Type | Purpose | Duration | Participant Role | Monitoring | Risk Level | Best For |
|---|---|---|---|---|---|---|
| Phase I Trial | Safety & dosing | Varies | Early-stage participation | Intensive | Higher | New interventions |
| Phase II Trial | Effectiveness and side effects | Varies | Treatment evaluation | Frequent | Moderate | Emerging therapies |
| Observational Study | Data collection | Varies | No intervention required | Minimal | Low | Long-term outcomes |
Who Can Participate in Clinical Research?
Screening & Enrollment
Clinical research participants must meet specific eligibility criteria that vary by study protocol. Generally, candidates have a diagnosed condition relevant to the research question, have not responded adequately to standard treatments, and are willing to comply with study procedures including assessments, intervention protocols, and follow-up visits.
General Eligibility for Research Participation
- Adults (age requirements vary by study)
- Diagnosed condition relevant to the study
- Ability to follow study procedures
- Ability to provide informed consent
- Stable treatment status when required by protocol
Who May Not Be Eligible for Clinical Trials
- Certain medical or psychiatric conditions depending on protocol
- Pregnancy or breastfeeding in some studies
- Medical conditions that increase risk
- Inability to attend required visits
All eligibility decisions are determined through a structured screening process. Jenny and Dr. Paulus review each case to ensure participant safety and scientific validity. Even if you don't qualify for a current study, we may contact you when new protocols open.
What to Expect During a Clinical Trial
Baseline Assessment
Research staff collect baseline measures—symptom scales, biomarkers, imaging, or other protocol-specific data—to track treatment response.
Intervention Phase
You receive the study intervention (medication, neuromodulation, psychotherapy, etc.) according to protocol timeline with close monitoring.
Follow-Up Visits
Regular assessments track symptoms, side effects, and outcomes. Jenny's team ensures protocol compliance and participant safety throughout.
Study Completion
Final assessments are collected. You'll discuss next steps—whether continuing treatment, transitioning to standard care, or enrolling in extension studies.
Risks & Safety in Clinical Research
Understanding Study Risks
Clinical research involves some level of uncertainty, particularly with newer or investigational treatments. Potential side effects vary depending on the study and intervention. Psychedelic therapies may involve temporary perceptual changes, anxiety, or nausea. Neuromodulation approaches can sometimes cause headache, scalp discomfort, or mood changes. Investigational medications may carry risks that are not yet fully understood, including possible long-term effects.
All studies are conducted under FDA regulations and institutional review board oversight to protect participant safety. Participants are monitored closely throughout the study, and any adverse events are evaluated and managed promptly. You may withdraw from a study at any time without penalty or impact on your standard medical care. Serious safety concerns are reported immediately and may lead to protocol adjustments if needed.
Jenny Piraino’s team applies structured safety monitoring protocols developed through extensive clinical research experience. Dr. Paulus contributes a translational medicine perspective to help anticipate and minimize potential risks. Every participant completes a detailed informed consent process outlining known risks, potential benefits, and study requirements, along with clear instructions on when to seek medical support.
While participation carries some risk, clinical research also provides access to emerging treatments under careful supervision. Our team ensures you have clear, accurate information to make an informed decision aligned with your health needs and goals.
Cost of Clinical Research Participation
Typically No-Cost to Participants
Most clinical research studies are funded by sponsors such as pharmaceutical companies, institutions, or grants.
What's Usually Covered
- Study Intervention: Investigational medication, neuromodulation treatments, or psychotherapy sessions required by protocol
- Research Assessments: Symptom scales, cognitive testing, biomarker collection, and imaging studies specified in protocol
- Study Visits: Clinic appointments for intervention delivery, monitoring, and data collection
- Related Medical Care: Treatment for study-related side effects or complications
What's Not Covered
- Standard Clinical Care: Routine psychiatric care not directly related to the research protocol
- Medications: Prescriptions outside the study intervention (though some protocols allow continuation of stable medications)
- Unrelated Conditions: Medical care for conditions not addressed by the research study
Specific cost coverage varies by protocol. During screening, Jenny's team provides detailed information about what is and isn't covered, along with any participant compensation offered. Insurance is typically not billed for research procedures, though pre-existing standard care may continue through your regular coverage.
Interested in joining a trial or partnering on research? Contact West Eastern Health at (904) 593-8480. We're located at 4210 Valley Ridge Blvd, Suite 101, Ponte Vedra Beach, FL 32081—serving Jacksonville, Jacksonville Beach, St. Johns, St. Augustine, Nocatee, and surrounding communities.
Why Partner with West Eastern Health
Ponte Vedra Beach Research Excellence
Experienced Investigators
Combined expertise in neuroscience and clinical trial execution
Integrated Clinical Care
Research conducted within an active care setting
Regulatory Compliance
Studies conducted under appropriate oversight and protocols
Translational Focus
Connecting scientific research with real-world clinical application
Explore More
Related Treatments
Discover complementary therapies designed to work alongside your treatment plan for optimal results.
Advanced & specialty care
Clinically guided ketamine-assisted treatment for depression, PTSD, and anxiety
Neurotherapy
Non-invasive neurofeedback, brain mapping, and TMS for optimal brain health
Clinical Research Services FAQ
Your Questions Answered
01 What research trials are currently available at West Eastern Health?
Our active studies focus on psychedelic-assisted therapies, neuromodulation for treatment-resistant conditions, and integrative approaches to mental health. Specific protocols vary over time. Contact Jenny Piraino's team at (904) 593-8480 to learn about current enrollment opportunities and eligibility criteria for ongoing trials.
02 Can I participate in a clinical trial if I'm already receiving treatment?
It depends on the study protocol. Some trials require participants to discontinue certain medications before enrollment, while others allow continuation of stable treatments. Many protocols include a washout period or require medication stability for a specified time. Jenny's team reviews your current treatment during screening to determine eligibility.
03 How do clinical trials work and what is my commitment?
Clinical trials follow a structured protocol specifying the intervention, assessment schedule, and follow-up duration. You'll attend regular study visits (weekly to monthly depending on protocol), complete symptom assessments, and receive the investigational treatment. Most trials last 8-24 weeks. You can withdraw at any time without penalty or impact on your regular clinical care.
04 What conditions are being studied in your research program?
West Eastern Health investigates treatment-resistant depression, PTSD and trauma-related conditions, chronic pain, neurological disorders including traumatic brain injury, and cancer-related mental health challenges. Our research emphasizes psychedelic therapies, neuromodulation techniques like TMS and neurofeedback, and translational approaches connecting neuroscience to clinical practice.
05 How do I partner with West Eastern Health on research projects?
We collaborate with pharmaceutical companies, academic institutions, and research organizations on investigator-initiated studies and industry-sponsored trials. Dr. Paulus brings 15+ years of translational research and Phase I/II trial design from Mayo Clinic. Contact Jenny Piraino at (904) 593-8480 to discuss partnership opportunities including site feasibility, protocol development, and collaborative research initiatives.
06 Will my insurance cover clinical trial participation?
Study-related care is typically funded by the research sponsor and not billed to insurance. Standard clinical care unrelated to the research protocol may continue through your insurance. During screening, our team clarifies exactly what is covered by the study versus what would be billed through your regular healthcare coverage.
07 Is clinical research safe?
All research at West Eastern Health is conducted under FDA regulations and institutional review board oversight. While no intervention is entirely without risk, our protocols include rigorous safety monitoring. You'll receive detailed informed consent explaining known and potential risks. Jenny's 13+ years of neuroscience research experience ensures comprehensive safety protocols and adverse event management.
08 What happens after the research study ends?
Post-study options depend on the protocol and your response. Some trials offer extension phases allowing continued access to the intervention. Others transition participants to standard clinical care or commercially available versions of the treatment (if approved). Jenny's team discusses all post-trial options during final study visits to ensure continuity of care.
Location4210 Valley Ridge Blvd, Suite 101
Ponte Vedra Beach, FL, 32081
Ponte Vedra Beach, FL, 32081
Phone(904) 593-8480
Schedule Your Clinical Research Services Consultation
References
- PubMed (PMID: 34233864) - Psilocybin for treatment-resistant depression shows sustained improvement at 12-month follow-up in Phase II trial.
- PubMed (PMID: 33782904) - Ketamine demonstrates rapid antidepressant effects with single infusion in major depressive disorder meta-analysis.
- PubMed (PMID: 32726529) - TMS combined with psychotherapy produces superior outcomes for PTSD compared to either intervention alone.
- PubMed (PMID: 31006551) - Psychedelic-assisted psychotherapy for PTSD shows large effect sizes with durable symptom reduction in Phase III trials.
- PubMed (PMID: 35523636) - Cancer patients receiving integrated mental health care demonstrate improved quality of life and treatment adherence in observational study.
- PubMed (PMID: 33257748) - Neurofeedback training improves attention and executive function in adults with ADHD across multiple randomized controlled trials.