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OPTIMIZE Study

Join The OPTIMIZE Study at Vail Health

An Investigation of Strategies to Understand and Optimize the Effects of Psilocybin on Depression (The OPTIMIZE Study)

Main Investigators: Charles Raison, MD

Vail Health Behavioral Health is conducting this investigational study to explore the potential effects of psilocybin on individuals experiencing depression, particularly when combined with investigational transcutaneous auricular Vagus Nerve Stimulation (taVNS). The taVNS used in this study is a non-invasive, at-home procedure that applies gentle electrical stimulation to the ear.

Psilocybin is a drug with temporary psychedelic effects that is not approved by the US Food and Drug Administration (FDA). 

Please note, this study is for research purposes only and not intended as a treatment. Additional study details are provided below.

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Study Description:

Condition: Depression

Overall Status: Recruiting

 

What's Involved:

Participation lasts up to 17 weeks and includes:

  • Screening Visit (4 hours): Assess eligibility through physical exams, questionnaires, and blood/urine samples. 
  • Two Baseline Visits (3-3.75 hours each): Complete questionnaires and prepare for dosing. An additional blood sample will be collected during the second baseline visit
  • Dosing Session (8-10 hours): Take 25 mg of psilocybin under supervision.
  • After the Dosing Session: Participants will be randomly assigned to one of the following groups for the week following dosing:
    1. Active taVNS at Home - Use a taVNS device at home twice daily for seven day
    2. Sham taVNS at Home - Use a sham (placebo) version of the taVNS device at home twice daily for seven days. It looks and feels like the real device but doesn’t deliver active stimulation.
    3. No taVNS - You won’t use a taVNS device during this period.
  • Five Follow-Up Visits (1.25-3 hours each): Complete questionnaires and discuss and reflect on your experiences. A final blood sample will be collected during the last visit.

You'll also complete questionnaires and voice diaries at home using the Fabla app before and after dosing. Additionally, you'll wear a dedicated Android device with an Electronically Activated Recorder (EAR) app to record sound snippets of your daily activities before and after the dosing session.

Learn More on ClinicalTrials.gov: NCT06512194

 

Who Can Participate:

Participants Must:

  1. Be 18 to 70 years old.

  2. Be experiencing a major depressive episode of at least 60 days duration of moderate or greater severity.

  3. Speak English (able to provide informed consent and complete questionnaires in English).

  4. Be willing to comply with all study procedures and available for the duration of the study.

  5. Be able to swallow capsules.

  6. Be medically healthy.

 

Financial Compensation:

Participants will be compensated for their time and participation. The total compensation may be up to $775, depending on the number of study visits and assessments completed

 

Will volunteering for this study help me?

Receiving psilocybin with psychological support in a clinical trial may improve your well-being. If you are in the group that gets study treatment (taVNS stimulation) after psilocybin dosing, this may work better than receiving psilocybin alone, but this is not currently known, which is why we are doing the study. Psilocybin and/or taVNS stimulation might not work at all or might have unpleasant side effects. Even if the study doesn’t directly benefit you, your participation could help others in the future by advancing our understanding of how psilocybin, combined with taVNS stimulation, may enhance well-being.

 

How to Participate?

If you're interested in joining our research study, please complete the pre-screening form by clicking the “See if You Pre-Qualify” button below. This will help us determine if you meet the initial qualifications for participation.

Should you qualify, a member of our study team will reach out to you for a follow-up interview and further assessment.
 

See if You Pre-Qualify

 

Location: Study visits will occur at the locations listed below.  

Wiegers Clinic - Building B
439 Edwards Access Rd, STE B204
Edwards, CO 81632

 

 Questions?

For additional questions, please contact the study team at BHIC@vailhealth.org

 

See if You Pre-Qualify