Psilocybin for Treatment of Obsessive Compulsive Disorder

Psilocybin

Brief Summary

This study will evaluate whether psilocybin, a hallucinogenic drug, improves symptoms of obsessive compulsive disorder (OCD), whether it is safely tolerated as treatment of OCD, and will investigate the mechanisms by which it works.

Intervention / Treatment

  • Drug: Psilocybin 100 mcg/kg
  • Drug: Psilocybin 300 mcg/kg
  • Drug: Lorazepam 1 mg

Condition or Disease

  • Obsessive-compulsive Disorder (OCD)

Phase

Study Design

Study type: Interventional
Status: Recruiting
Study results: No Results Available
Age: 18 Years to 65 Years   (Adult, Older Adult)
Enrollment: 15 ()
Funded by: Other

Masking

Clinical Trial Dates

Start date: Jan 02, 2019
Primary Completion: Oct 01, 2022
Completion Date: Dec 01, 2022
Study First Posted: Oct 04, 2017
Results First Posted: Aug 30, 2020
Last Updated: Apr 25, 2022

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

Location

Tucson, Arizona, USA

The study seeks to improve our ability to treat and improve the lives of people who have obsessive-compulsive disorder (OCD) by exploring the benefits of psilocybin, a mind-altering drug that changes activity in brain areas believed to be involved in OCD. Anecdotal reports and results from previous research support this idea. This two-phase study will enroll patients with symptomatic OCD who are not taking mind-altering medications or street drugs.

During Phase One, neither participants nor the investigators will know which drugs or doses are administered. This information will be available if it is medically necessary to reveal which drugs and doses were administered. Five subjects in each group will receive study drug a total of four times, separated by one week. During Phase Two, participants will not know which drugs or doses they receive, but the investigators will know. All participants will receive psilocybin at some point during study participation.

Participants will be randomly assigned to one of the following groups:

  1. Low dose (100 µg/kg) psilocybin,
  2. High dose (300 µg/kg) psilocybin, or
  3. Lorazepam (1 mg), a calming medication. Lorazepam is used often for anxiety and will be used to mask which drug participants receive.

Participants will spend approximately 12 hours at the research site under observation during each visit, until they are free of the mind-altering effects of the drug and are determined by the psychiatrist to be safe to go home accompanied by a responsible adult. The effects of low versus high doses, and the additive effects of repeated doses will be analyzed and will be compared to the effects of lorazepam.

Eligibility Criteria

Sex: All
Minimum Age: 18
Maximum Age: 65

This clinical trial is recruiting

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More Details

NCT Number: NCT03300947
Acronym: PSILOCD
Other IDs: 1707613822
Study URL: https://ClinicalTrials.gov/show/NCT03300947
Last updated: Jun 16, 2022