Psilocybin Assisted Psychotherapy for Treatment Resistant Depression and Co-occurring Substance Use Disorder
Indiana University
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
Description
This is a double-blind randomized clinical trial to examine the safety and efficacy of a single dose of psilocybin (5mg or 10mg or 25mg) in reducing substance use severity and depression symptoms in N=50 veterans and first responders with treatment resistant depression (TRD) and co-occurring substance use disorder (SUD). The study will be conducted at Goodman Hall outpatient clinic located at Indiana University, Department of Psychiatry. All participants will take part in two intake visits (one to conduct safety tests and establish eligibility, and one to collect baseline and covariate data).…
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: i) Veterans or first responders ii) 18 -70 years of age iii) 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), iv) 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, v) Able to read English and complete study evaluation…
Interventions
- DrugPsilocybin
Participants will be randomly administered a single dose of either 5mg or 10mg or 25mg psilocybin
Locations (2)
- Goodman Hall, Dept of Psychiatry, Indiana UniversityIndianapolis, Indiana
- The Stark Neuroscience Building (Goodman Hall)Indianapolis, Indiana