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Psilocybin for Treatment of Obsessive Compulsive Disorder (PSILOCD)

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ClinicalTrials.gov Identifier: NCT03300947
Recruitment Status : Not yet recruiting
First Posted : October 4, 2017
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
Francisco A Moreno, University of Arizona

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.

Condition or disease Intervention/treatment Phase
Obsessive-compulsive Disorder (OCD) Drug: Psilocybin 100 mcg/kg Drug: Psilocybin 300 mcg/kg Drug: Lorazepam 1 mg Phase 2

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
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
Official Title: Psilocybin for Treatment of Obsessive Compulsive Disorder
Estimated Study Start Date : January 7, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Lorazepam

Arm Intervention/treatment
Experimental: High-dose Psilocybin
Psilocybin 300 mcg/kg once per week, every week, for 8 weeks
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"

Experimental: High- or Low-dose Psilocybin
Psilocybin 100 mcg/kg or psilocybin 300 mcg/kg once per week, every week, for 8 weeks
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"

Placebo Comparator: High-dose Psilocybin or Lorazepam
Psilocybin 300 mcg/kg or Lorazepam 1 mg once per week, every week, for 8 weeks
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




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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)

  2. 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.

  3. 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.

  4. 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).

  5. 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).

  6. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  • While subjects may continue to use antidepressant medication for OCD, 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03300947


Contacts
Contact: Marcy Watchman (520) 237-8155 OCD@psychiatry.arizona.edu

Locations
United States, Arizona
Clinical and Translational Research Center Not yet recruiting
Tucson, Arizona, United States, 85724
Principal Investigator: Francisco A. Moreno, MD         
Principal Investigator: John Allen, PhD         
Sub-Investigator: Michael Grandner, PhD         
Principal Investigator: Manoj Saranathan, PhD         
Sub-Investigator: Ole Thienhaus, MD         
Sponsors and Collaborators
University of Arizona
Investigators
Principal Investigator: Francisco A. Moreno, MD Professor of Psychiatry and Associate Vice President, Diversity and Inclusion

Additional Information:
Publications of Results:
Responsible Party: Francisco A Moreno, Associate Vice President, Diversity and Inclusion; Professor, Psychiatry, University of Arizona
ClinicalTrials.gov Identifier: NCT03300947     History of Changes
Other Study ID Numbers: 1707613822
First Posted: October 4, 2017    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Disease
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Pathologic Processes
Personality Disorders
Mental Disorders
Anxiety Disorders
Lorazepam
Psilocybin
Anticonvulsants
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hallucinogens