Psilocybin for OCD

Overseen By Esmeralda Terrazas

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether psilocybin, a drug that can alter brain activity, might help individuals with obsessive-compulsive disorder (OCD). Participants with significant OCD symptoms, who are not using other mind-altering drugs, will be randomly assigned to receive either a low or high dose of psilocybin in supervised sessions over 12 weeks. The trial will measure changes in OCD symptoms, daily functioning, and quality of life. Ideal candidates have moderate to severe OCD and have not found relief with standard treatments. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this potentially groundbreaking treatment.

Will I have to stop taking my current medications?

Yes, you will need to stop taking certain medications and supplements at least two weeks before starting the trial. This includes antidepressants, some supplements, and other treatments for OCD. If you're taking fluoxetine, it must be stopped at least six weeks before the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found psilocybin safe and well-tolerated for people with OCD. Some mild side effects, such as temporary high blood pressure, appeared but resolved quickly. Research also showed that a single 10 mg dose of psilocybin was well-tolerated and might help reduce OCD symptoms. These findings suggest that both low and high doses of psilocybin in this trial are expected to be safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment for OCD?

Researchers are excited about psilocybin as a treatment for OCD because it offers a novel approach compared to standard therapies like SSRIs and cognitive-behavioral therapy. Unlike these traditional treatments, psilocybin works by targeting serotonin receptors in the brain to potentially induce rapid and profound changes in mood and perception. This psychedelic compound could offer quicker symptom relief, with effects possibly noticeable after just a few sessions, unlike the weeks or months often required for current options. Additionally, psilocybin's unique mechanism may address OCD symptoms in patients who have not responded well to existing treatments.

What evidence suggests that psilocybin might be an effective treatment for OCD?

Research has shown that psilocybin might help reduce symptoms of obsessive-compulsive disorder (OCD). One study found that a single 10 mg dose of psilocybin was safe and possibly beneficial for individuals with OCD. Another study reported positive effects from psilocybin use among people with OCD. These findings suggest that psilocybin can alter brain activity in areas related to OCD, potentially leading to symptom relief. This trial examines both low (10 mg) and high (30 mg) doses to assess their potential benefits. Early evidence indicates that psilocybin could be a promising treatment option for OCD. ^{1 2 5 6 7}

Who Is on the Research Team?

Francisco Moreno, MD

Principal Investigator

University of Arizona, College of Medicine, Tucson

Are You a Good Fit for This Trial?

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

EKG QTc ≥ 450 msec

I have serious kidney or liver problems.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11635828/

Psychedelics for the Treatment of Obsessive–Compulsive ... For example, a retrospective online survey found that patients with OCD self-medicating with psilocybin and LSD reported their treatment to be effective, and ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0010440X25000471

Single-dose (10 mg) psilocybin reduces symptoms in ... A 10 mg dose of oral psilocybin was found to be well-tolerated and potentially efficacious in patients with OCD.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06992999

NCT06992999 | Psilocybin for Treatment of OCD-2 The study will evaluate the tolerability, safety, subjective experience, and efficacy of psilocybin for improving OCD, obtain the preliminary data needed as a ...

4. yalemedicine.org yalemedicine.org/clinical-trials/neural-correlates-of-the-effects-of-psilocybin-in-obsessive-compulsive-disorder

Efficacy of Psilocybin in OCD: a Double-Blind, Placebo- ... This study aims to investigate the effects of oral psilocybin on OCD symptomatology and provide the first evidence of the neural mechanism that may mediate ...

5. nature.com nature.com/articles/s41380-024-02786-0

Striking long-term beneficial effects of single dose ... Secondary outcome measures such as head-body twitches and anxiety all showed a significant improvement over 21 days. Notably, in mice that ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06299319

Study Details | NCT06299319 | Feasibility, Clinical Effects, ... There is interest to see if similar effects may be provided in those with obsessive compulsive disorder (OCD). The purpose of this study is to evaluate the ...

7. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2023.1178529/full

Safety, tolerability, and clinical and neural effects of single ... This first-of-its-kind trial aims to evaluate the feasibility, safety, and tolerability of psilocybin in the treatment of OCD.