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Psilocybin for Treatment of Obsessive Compulsive Disorder (PSILOCD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03300947
Recruitment Status : Recruiting
First Posted : October 4, 2017
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
Francisco A Moreno, University of Arizona

Tracking Information
First Submitted Date  ICMJE September 14, 2017
First Posted Date  ICMJE October 4, 2017
Last Update Posted Date August 28, 2019
Actual Study Start Date  ICMJE January 2, 2019
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 2, 2017)
Acute effects on Obsessive-Compulsive symptom severity [ Time Frame: 0, 4, and 8 hours, and daily ratings for one week following each double blind dose ingestion ]
Prospective Assessment of YBOCS (Yale-Brown Obsessive Compulsive Scale) score comparing each psilocybin dose and active placebo (Lorazepam).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 2, 2017)
  • Acute Incidence of Treatment Emergent Adverse Events [ Time Frame: At 0, and 24 hours after blinded medication ingestion ]
    Prospective active inquiry of adverse events with the SAFTEE-GI (systematic assessment for treatment emergent events-general inquiry) comparing each psilocybin dose and active placebo (Lorazepam)
  • Repeated administration effects on Obsessive-Compulsive symptom severity [ Time Frame: Follow-up assessments will be conducted over the phone weekly (± 3 days) for one month after last dose, monthly (± 7 days) for three months beginning 28 days after last dose, and then once at 6 months after last dose (± 7 days). ]
    Prospective Assessment of YBOCS (Yale-Brown Obsessive Compulsive Scale) after repeated administration of study drug.
  • Long Term Incidence of Treatment Emergent Psychiatric Adverse Events [ Time Frame: Follow-up assessments will be conducted over the phone weekly (± 3 days) for one month after last dose, monthly (± 7 days) for three months beginning 28 days after last dose, and then once at 6 months after last dose (± 7 days). ]
    Prospective Assessment with SCID-I (Structured Clinical Interview for DSM5 Disorders) screening tool will assess for onset of psychopathology or hallucinogen induced disorders after repeated use.
  • Changes in the magnitude of Error Related Negativity (an electroencephalographic biomarker of OCD) [ Time Frame: Baseline, and 10 hours after ingestion of study dose 1, 4, and 8. ]
    Prospective Assessment of Error Related Negative Potential (ERN) comparing each psilocybin dose and active placebo (Lorazepam).
  • Change in Depression Symptoms [ Time Frame: Baseline and 24 hours after each study dose ingestion, and two weeks after last dose administration. ]
    Prospective Assessment of Montgomery-Asberg Depression Rating Scale (MADRS) Score comparing each psilocybin dose and active placebo (Lorazepam).
  • Changes in functional connectivity between the Caudate Nucleus (CN) and Orbital Frontal Cortex (OFC) [ Time Frame: Imaging at baseline, and 11 hours post ingestion on weeks 1, 4, and 8. YBOCS at baseline and 8 hours after ingestion at weeks 1, 4, and 8. ]
    Prospective Assessment of Functional Connectivity in CN and OFC comparing each psilocybin dose and active placebo (Lorazepam).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Psilocybin for Treatment of Obsessive Compulsive Disorder
Official Title  ICMJE Psilocybin for Treatment of Obsessive Compulsive Disorder
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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
All participants will be randomly assigned to administration of low dose (100 µg/kg) psilocybin, High dose (300 µg/kg) psilocybin, or Lorazepam (1 mg). Eight different sessions divided in two phases will ensure all subjects are exposed to psilocybin at some point during the study in a blinded fashion.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Phase One: Double blind (both participant AND researchers (In room Care Provider, Investigators, Blinded Outcomes Assessor) Phase Two: Single blind (Participant and Blinded Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Obsessive-compulsive Disorder (OCD)
Intervention  ICMJE
  • Drug: Psilocybin 100 mcg/kg
    Psilocybin belongs to the class of hallucinogen or psychedelic drugs. It is one of the major psychoactive components in mushrooms of the Psilocybe genus ("magic mushrooms").
    Other Name: Psilocybine, "magic mushrooms"
  • Drug: Psilocybin 300 mcg/kg
    Psilocybin belongs to the class of hallucinogen or psychedelic drugs. It is one of the major psychoactive components in mushrooms of the Psilocybe genus ("magic mushrooms").
    Other Name: Psilocybine, "magic mushrooms"
  • Drug: Lorazepam 1 mg
    A medication used to treat anxiety belonging to a class of drugs known as benzodiazepines, which act on the central nervous system to produce a calming effect. This drug works by enhancing the effects of a certain natural chemical in the body (GABA).
    Other Name: Ativan, Intensol
Study Arms  ICMJE
  • Experimental: High-dose Psilocybin
    Psilocybin 300 mcg/kg once per week, every week, for 8 weeks
    Intervention: Drug: Psilocybin 300 mcg/kg
  • Experimental: High- or Low-dose Psilocybin
    Psilocybin 100 mcg/kg or psilocybin 300 mcg/kg once per week, every week, for 8 weeks
    Interventions:
    • Drug: Psilocybin 100 mcg/kg
    • Drug: Psilocybin 300 mcg/kg
  • Placebo Comparator: High-dose Psilocybin or Lorazepam
    Psilocybin 300 mcg/kg or Lorazepam 1 mg once per week, every week, for 8 weeks
    Interventions:
    • Drug: Psilocybin 300 mcg/kg
    • Drug: Lorazepam 1 mg
Publications * Moreno FA, Wiegand CB, Taitano EK, Delgado PL. Safety, tolerability, and efficacy of psilocybin in 9 patients with obsessive-compulsive disorder. J Clin Psychiatry. 2006 Nov;67(11):1735-40.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 2, 2017)
15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Have moderate to severe OCD (DSM-5) after diagnostic interview using the Structured Clinical Interview for DSM-5 Research Version (SCID-R).
  • Failed at least one adequate attempted routine care treatment.
  • Considered safe for independent living

Exclusion Criteria:

  • Concurrent psychosis, active substance use disorder, or a personal history of psychosis.
  • Medical illness based on physical examination and routine blood testing that may complicate cardiovascular safety or drug metabolism or excretion, such as uncontrolled hypertension, severe cardiac disease, or kidney or liver failure.
  • Unstable Chronic Obstructive Pulmonary Disease (COPD) or severe sleep apnea
  • Psychiatric comorbidity that may represent an acute risk to their own or others' safety.
  • Subjects may not be using antidepressant medication for OCD for at least two weeks before receiving study drug, and they cannot require any sedative, narcotic, or neuroleptic medications on a regular basis. Any of these medications they have taken should have been stopped long enough in the past to allow for their elimination and safe withdrawal prior to starting administration of the study drug. The specific time required will be dependent on the medication the patient was previously receiving.
  • Women who are pregnant, breastfeeding, or unwilling/unable to practice medically acceptable birth control during the study.
  • Allergy to lorazepam.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Katja Ehrman (520) 328-7185 ocd@psychiatry.arizona.edu
Contact: Francisco A Moreno 5206265327 fmoreno@email.arizona.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03300947
Other Study ID Numbers  ICMJE 1707613822
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Francisco A Moreno, University of Arizona
Study Sponsor  ICMJE University of Arizona
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Francisco A. Moreno, MD Professor of Psychiatry and Associate Vice President, Diversity and Inclusion
PRS Account University of Arizona
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP