Investigation to Understand and Optimize Psilocybin

Part of paid clinical trials in Edwards, Colorado.

Sponsor
Charles Raison
Study ID
NCT06512194
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Psilocybin — DRUG
    The psilocybin used in this study is synthesized under Good Manufacturing Practice (GMP) guidelines and is provided in a capsule containing 25 mg of synthetic psilocybin.
  • Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) — DEVICE
    Participants will be provided with a taVNS device and trained on its use. The device delivers gentle stimulation to the left ear.
  • Sham taVNS — DEVICE
    Participants will be provided with a taVNS device and trained on its use. The device delivers gentle stimulation to the left ear. In the sham condition, the device will simulate the sensations of active taVNS without delivering therapeutic stimulation.

Study Details

This study will examine the effects of a single dose of psilocybin, administered with psychological support, on symptoms of depression. It will also assess whether different post-dosing interventions, including a non-invasive technique called transcutaneous auricular Vagus Nerve Stimulation (taVNS), influence various psychological and behavioral outcomes. In addition, the study will explore objective measures of real-world social behavior and identify early behavioral responses that may be associated with long-term treatment outcomes.

Key Dates

Start date
May 13, 2025
Status verified
May 2025
Primary completion
May 31, 2029
Completion
May 31, 2029

Study Design

Enrollment
141 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1: Psilocybin + taVNS
    Participants in this arm will receive a single 25 mg dose of psilocybin, followed by twice-daily sessions of taVNS for 7 consecutive days. Each taVNS session will be paired with music and prompts related to the participant's psilocybin experience.
  • Sham Comparator: Group 2: Psilocybin + Sham taVNS
    Participants in this arm will receive a single 25 mg dose of psilocybin, followed by twice-daily sham taVNS sessions for 7 consecutive days. Each sham session will be paired with music and prompts related to the participant's psilocybin experience.
  • Active Comparator: Group 3: Psilocybin + No taVNS
    Participants in this arm will receive a single 25 mg dose of psilocybin, followed by no additional intervention. They will receive the standard psychological support related to their psilocybin experience, but no taVNS or sham device will be used.

Primary Outcome Measure

Montgomery-Åsberg Depression Rating Scale (MADRS) score [ Time Frame: Baseline 2, Week 8 Post-Psilocybin Dosing ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Vail Health Behavioral HealthEdwardsColorado81632
Program Manager
[email protected]
(970) 855-7374

Find similar trials in Edwards, CO

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
Vail Health Behavioral Health· Edwards, CO

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