Psilocybin for OCD

Overseen By Andrea Horne

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Francisco A Moreno

Must not be taking: Antidepressants, Antipsychotics, Sedatives, Opioids

Disqualifiers: Substance use disorder, Psychosis, Cardiovascular disease, others

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

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

Previous research indicates that psilocybin, a drug that changes activity in brain areas believed to be involved in obsessive-compulsive disorder (OCD), might improve treatment for, and improve lives of, people diagnosed with OCD. The investigators propose to study 20 patients with symptomatic OCD who are not taking mind altering medications or street drugs, to participate in a 12 week study. Participants will be assigned (by luck of the draw) to take low or high dose psilocybin in four dosing sessions separated by 3 weeks. Measurements for the severity of OCD, ability to function, perception of quality of life, safety and tolerability will be measured at baseline prior to drug administration, during the dosing periods, and at the end of study. Other measurements will include brain imaging via fMRI and brain tracing via electroencephalogram (EEG). The investigators believe that during medically supervised dosing sessions, both doses of psilocybin will be safe and well tolerated, and will reduce OCD symptoms. Because psilocybin is a potent drug and especially at the higher dose may induce altered states of consciousness, a thoughtfully implemented procedure for participant safety is in place. Information will be obtained to explore the effects of altered states of consciousness in the outcome of treatment and to find the mechanism of benefit.

Research Team

Francisco Moreno, MD

Principal Investigator

University of Arizona, College of Medicine, Tucson

Eligibility Criteria

This trial is for adults with Obsessive-Compulsive Disorder (OCD) who are not currently using mind-altering medications or street drugs. They will participate in a 12-week study involving low or high doses of psilocybin, administered in four sessions.

Inclusion Criteria

I am capable of living on my own safely.

I am 18 years old or older.

Have OCD (DSM-5) based on diagnostic interview using the Structured Clinical Interview for DSM-5 Research Version (SCID)

Exclusion Criteria

I have serious kidney or liver problems.

EKG QTc ≥ 450 msec

Suicidal behavior within the 12 months prior to enrollment, or significant risk of suicide

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a low dose (10mg) or high dose (30mg) of psilocybin in four dosing sessions, each separated by three weeks

12 weeks

4 dosing sessions (in-person)

Follow-up

Participants are monitored for safety, tolerability, and effectiveness of psilocybin treatment

12 months

Treatment Details

Interventions

• Psilocybin

Trial Overview The study tests the effects of two different doses of psilocybin on OCD symptoms. Participants will be randomly assigned to receive either a low or high dose over four dosing sessions, with their condition and brain activity monitored through various methods including fMRI and EEG.

Participant Groups

Group I: Low Dose psilocybin (10mg) Active Control 1 Intervention

Subjects will receive a low dose (10mg) of psilocybin at four study drug ingesting sessions. Each drug ingestion session will be separated by three weeks.

Group II: High dose psilocybin (30mg) Active Control 1 Intervention

Subjects will receive a high dose (30mg) of psilocybin at four study drug ingesting sessions. Each drug ingestion session will be separated by three weeks.

Who Is Running the Clinical Trial?

Francisco A Moreno

Lead Sponsor

University of Arizona

Collaborator

Trials

545

Recruited

161,000+