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Psilocybin Assisted Psychotherapy for Treatment Resistant Depression and Co-occurring Substance Use Disorder

NCT07499583 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-03-30

No results posted yet for this 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

Conditions

Interventions

DRUG

Psilocybin

Participants will be randomly administered a single dose of either 5mg or 10mg or 25mg psilocybin

Sponsors & Collaborators

  • Indiana University

    lead OTHER

Principal Investigators

  • Susan K Conroy, PhD · Indiana University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2031-01-01
Completion
2031-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07499583 on ClinicalTrials.gov