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Life sciences · Phase 1/2 Trial
ClinicalTrials.gov · October 23, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 1/2 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT07499583). This is a study registration, not published results. Lead sponsor: Indiana University. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 50 participants (ESTIMATED). Conditions: Treatment Resistant Depression, Substance Use Disorders. Interventions: DRUG: Psilocybin. Primary outcome measures: percentage number of participants with Adverse Events (AEs) , Weekly for 12-weeks and once during a 60-day follow-up; Change in % number of positive urines , Weekly for 12-weeks; Change in % number of days spent using substances , Weekly for 12-weeks TLFB and 5 times per day in weeks 1, 2, 5, 6, 10 & 11 (brief items); Change in severity of depression symptoms , Weekly for 12-weeks QIDS and 5 times per day in weeks 1, 2, 5, 6, 10 & 11 for PANAS; Changes in plasma brain-derived neurotrophic factor (BDNF) during stress exposure , Change from baseline (week 2) to post psilocybin administration (week 5); Change in resting brain functional connectivity of the default mode network (DMN). , Change from baseline (week 2) to post psilocybin administration (week 5). Brief 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). 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