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

Clinical trial · Indiana University

- Archive id: nct:NCT07499583
- Published: 2026-03-30
- Venue: ClinicalTrials.gov
- ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT07499583
- Source URL: https://clinicaltrials.gov/study/NCT07499583
- Provenance: clinicaltrials

## Abstract

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. Investigators 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 a sample of individuals 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

_Abstract reproduced under ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters._

## Trial details

- status: NOT_YET_RECRUITING
- phase: PHASE1, PHASE2
- study type: INTERVENTIONAL
- enrollment: 50
- sponsor: Indiana University
- conditions: Treatment Resistant Depression; Substance Use Disorders
- interventions: DRUG: Psilocybin
- start date: 2027-02-01
- start date type: ESTIMATED
- primary completion date: 2031-02-01
- has results: false
- data source: ClinicalTrials.gov
- data processed: 2026-10-29T09:00:05
- modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters

Topics: [Novel Psychiatric Therapeutics](https://space-kitty.com/topics/psychiatric-therapeutics)

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