Not yet recruitingPhase 1 / Phase 2NCT07499583
Psilocybin Assisted Psychotherapy for Treatment Resistant Depression and Co-occurring Substance Use Disorder
The goal of this clinical trial is to learn if a single dose of psilocybin (5mg Vs 10mg Vs 25mg) alongside psychotherapy is safe and can help treat treatment resistant depression (TRD) with co-occurring substance use disorder (SUD). The participant sample will be enriched for veterans and first responders. (The sponsor's summary, shortened.)
Eligibility and contacts on ClinicalTrials.govThe registry record
- Status
- Not yet recruiting
- Phase
- Phase 1 / Phase 2
- Conditions
- Treatment Resistant Depression; Substance Use Disorders
- Intervention
- Psilocybin
- Sponsor
- Indiana University
- Ages
- 18 Years and over
- Sex
- All
- Healthy volunteers
- No
- Enrolment
- 50 people (planned)
- Start
- 1 February 2027
- Primary completion
- 1 February 2031
- Registry last updated
- 23 October 2026
Sites (2)
- Goodman Hall, Dept of Psychiatry, Indiana University, Indianapolis, Indiana, United States
- The Stark Neuroscience Building (Goodman Hall), Indianapolis, Indiana, United States
How joining a trial works
- Free to take part
- Trials generally cost participants nothing for the study drug and the study visits, and some pay for travel or time. Check what a study covers on its registry page.
- Screened first
- Every study screens volunteers with questionnaires, medical history and often a physical and psychiatric check. Many people who apply are not enrolled.
- Eligibility is strict
- Common exclusions include a personal or family history of psychosis or bipolar disorder, some heart conditions, pregnancy and certain medications, which you may be asked to stop under medical supervision. Never stop a medication on your own to qualify.
- You may get a placebo
- Many trials compare psilocybin with a placebo or a low dose, and you may not be told which you had until the study ends.
- Contact the study team through the registry
- Each registry record lists the study contacts and sites. We do not republish personal emails or phone numbers; use the link on each trial page.
- Not medical advice
- This is a list of registry records, not a recommendation. Talk to your doctor before applying. Disclaimer · Safety and medications
Source: ClinicalTrials.gov API v2, U.S. National Library of Medicine, read 28 October 2026. Filter: overall status RECRUITING or NOT_YET_RECRUITING; an intervention named psilocybin, psilocin, COMP360 or CYB003. Refreshed weekly; a study's own registry page is always the current record.
Record read from ClinicalTrials.gov API v2, U.S. National Library of Medicine on 28 October 2026. All psilocybin trials