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

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Indiana University
Study ID
NCT07499583
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Substance Use Disorders
  • Treatment Resistant Depression

Eligibility Criteria

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

Interventions

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

Study Details

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

Key Dates

Start date
Aug 1, 2026
Status verified
Mar 2026
Primary completion
Jan 1, 2031
Completion
Feb 28, 2031

Study Design

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

Arms

  • Experimental: Psilocybin Dose - Low
    Experimental: Participants receive a single oral dose of psilocybin 5mgs
  • Experimental: Psilocybin Dose - Moderate
    Experimental: Participants receive a single oral dose of psilocybin 10mgs
  • Experimental: Psilocybin Dose - High
    Experimental: Participants receive a single oral dose of psilocybin 25mgs

Primary Outcome Measure

percentage number of participants with Adverse Events (AEs) [ Time Frame: Weekly for 12-weeks and once during a 60-day follow-up ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Goodman Hall, Dept of Psychiatry, Indiana UniversityIndianapolisIndiana46202-3082
Susan K Conroy, MD
[email protected]
Helen Fox, PhD
[email protected]
2036719643
The Stark Neuroscience Building (Goodman Hall)IndianapolisIndiana46202-

Find similar trials in Indianapolis, IN

By research site
Goodman Hall, Dept of Psychiatry, Indiana University· Indianapolis, INThe Stark Neuroscience Building (Goodman Hall)· Indianapolis, IN

Related Studies