Psilocybin Assisted Psychotherapy for Depression and Drug Addiction

Not yet recruiting at 1 trial location

Overseen By Susan K Conroy, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Indiana University

Must not be taking: Classic psychedelics

Disqualifiers: Schizophrenia, Bipolar, PTSD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 11

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Who Is on the Research Team?

Susan K Conroy, PhD

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

Inclusion Criteria

I am a veteran or first responder, aged 18-70, with treatment-resistant depression and moderate to severe use of one main substance.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

2 visits (in-person)

Preparatory Psychotherapy

Participants undergo three preparatory psychotherapy sessions with a certified psilocybin counselor

3 weeks

3 visits (in-person)

Psilocybin Administration

Participants receive a single dose of psilocybin (5mg, 10mg, or 25mg) during an 8 to 10 hour session

1 day

1 visit (in-person)

Integrative Psychotherapy

Participants engage in three weekly integrative psychotherapy sessions following psilocybin administration

3 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including daily assessments and brain scans

6 weeks

Daily assessments (remote), 2 brain scans (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Psilocybin

How Is the Trial Designed?

Group I: Psilocybin Dose - Moderate Experimental Treatment 1 Intervention

Experimental: Participants receive a single oral dose of psilocybin 10mgs

Group II: Psilocybin Dose - Low Experimental Treatment 1 Intervention

Experimental: Participants receive a single oral dose of psilocybin 5mgs

Group III: Psilocybin Dose - High Experimental Treatment 1 Intervention

Experimental: Participants receive a single oral dose of psilocybin 25mgs

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+