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NCT07499583 · ClinicalTrials.gov registry record · Phase 1
Psilocybin Assisted Psychotherapy for Treatment Resistant Depression and Co-occurring Substance Use Disorder
A Phase 1 study, sponsored by Indiana University.
- Not yet
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
NCT07499583 is a Phase 1 study that has not yet begun recruiting, run by Indiana University. The registered enrollment target is 50 participants.
The verdict
NCT07499583, a Phase 1 study, has not yet begun recruiting, sponsored by Indiana University.
- NOT YET RECRUITING
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
Study Summary
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) in veterans and first responders. We seek to answer: * Whether 5mgs, 10mgs and 25mgs of psilocybin are safe in individuals with co-occurring TRD and SUD * Whether psilocybin assisted psychotherapy will reduce substance use severity and depression symptoms * What neurobiological processes are associated with the effects of psilocybin assisted psychotherapy. The researchers will compare the effects of a single dose of psilocybin (either 5mgs or 10mgs or 25mg) alongside psychotherapy on substance use severity and depression symptoms over six weeks in veterans and first responders with TRD and co-occurring SUD. In this 14-week study, participants will: * Visit the clinic for two intake sessions * Complete seven psychotherapy sessions. This will include three sessions before psilocybin administration, an 8 to 10 hour dosing session, and three sessions following psilocybin administration * Complete short, repeated daily assessments for six weeks, in total, before and after psilocybin administration * Complete two brain scans before and after psilocybin administration
Interventions
- DRUG Psilocybin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2026-08-01 |
| Est. Completion | 2031-02-28 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07499583
The ClinicalTrials.gov registry entry for NCT07499583 describes a study currently listed as not yet recruiting, categorized as Phase 1. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Psilocybin is the first listed.
NCT07499583 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07499583 about?
NCT07499583 is a clinical study titled "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) in veterans and first responders. We seek to answer: * Whether 5mgs...
What is the current status of trial NCT07499583?
This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2026-08-01. Estimated completion is 2031-02-28.
What interventions are being tested in trial NCT07499583?
The interventions under investigation include: Psilocybin (DRUG).
Who is sponsoring clinical trial NCT07499583?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
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