What this study is
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
What's being tested
- Psilocybin
Intervention · DRUG
Participants will be randomly administered a single dose of either 5mg or 10mg or 25mg psilocybin
Study details
- Sponsor
- Indiana University
- Conditions
- Treatment Resistant Depression · Substance Use Disorders
- Enrolling
- 50 people
- Starts
- 2027-02-01
- Est. completion
- 2031-02-01
- Design
- Quadruple-blind, randomized, parallel groups, Phase 1, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Men and Women 18 years or over (veterans and first responders encouraged)
- Meets criteria for TRD (current major depressive episode without psychotic features by the Mini-International Neuropsychiatric Interview - MINI, with failure to respond to 2 or more evidence-based anti-depressants in the current episode)
- Meets moderate to severe use criteria for one primary substance (alcohol, cocaine, opioids/heroin, or cannabis). Moderate to severe co-use of nicotine also acceptable, as well as mild/recreational use of other substances
- Able to read English and complete study evaluations and consent
- In good health as verified by screening examination and medical history
- Able to safely receive MRI
You can't join if
- Exclusionary psychiatric conditions include schizophrenia, schizoaffective disorder, bipolar disorder, current post-traumatic stress disorder, or history of medically serious suicide attempt
- Actively/imminently suicidal (QIDS-SR question 12 score >2, Hamilton Depression Scale (HAM-D) question 3 score >3, or Montgomery-Åsberg Depression Rating Scale (MADRS) question 10 >4)
- A family history of schizophrenia or schizoaffective disorder (first- or second-degree relatives), or bipolar disorder type 1 (first degree relatives)
- Use of selective serotonin reuptake inhibitors (SSRIs) and other medications are acceptable if dose has remained stable for 6 months and is not contra-indicated with psilocybin, as per the study physician
- Any prior use of classic psychedelics, including psilocybin
- Medical conditions that would preclude safe participation in the trial (e.g., seizure disorder, significantly impaired liver function, coronary artery disease, heart failure, history of cerebrovascular accident, severe asthma, hyperthyroidism, narrow-angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy, or bladder-neck obstruction)
- Sitting blood pressure below 90/50 mmHg or above 165/95 mmHg
- EKG evidence of any clinically significant conduction abnormalities, including a Bazett's corrected QT interval (QTc) of >450 msec for men and QTc >470 msec for women
- Women who are pregnant or lactating
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openGoodman Hall, Dept of Psychiatry, Indiana University
Indianapolis, Indiana, United States
- Susan K Conroy, MD · Contactpsycrsch@iu.edu
- Helen Fox, PhD · Contact2036719643psycrsch@iu.edu
The Stark Neuroscience Building (Goodman Hall)
Indianapolis, Indiana, United States
Study team
Sponsor
Indiana University
Study ID 28032
Principal investigator
Susan K Conroy, MD, PhD
Indiana University
Principal investigator
Helen C Fox, PhD
Indiana University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.