Psilocybin for Treatment of Obsessive Compulsive Disorder

NCT03300947 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: 1707613822
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Obsessive-compulsive Disorder (OCD)

Outcome Measures

Primary Outcomes (1)

• Treatment-phase effects on Obsessive-Compulsive symptom severity

  Prospective Assessment of YBOCS (Yale-Brown Obsessive Compulsive Scale) score comparing each psilocybin dose and active placebo (Lorazepam).

  weekly Y-BOCS rating prior to ingestion of study drug on Week 1 through 8, and week 9 (follow up week 1)

Secondary Outcomes (7)

• Acute Incidence of Treatment Emergent Adverse Events

  At 0, and 24 hours after blinded medication ingestion

• Duration of Effects on Obsessive-Compulsive symptom severity

  Follow-up assessments will be conducted weekly 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).

• Long Term Incidence and Duration of Treatment Emergent Psychiatric Adverse Events

  Follow-up assessments will be conducted weekly over the phone (± 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).

• Changes in the magnitude of Error Related Negativity (an electroencephalographic biomarker of OCD) assessed by Error-related negativity (voltage) and mid-frontal theta power (time-frequency approach)

  Baseline, and 9-10 hours after ingestion of study dose 1, 4, and 8.

• Prospective Self-Assessment of Depression Symptoms

  Baseline, 24 hours after each dose during 8 week active phase, and during the follow-up phase (weekly for one month after last dose, monthly for three months beginning 28 days after last dose, and then once at 6 months after last dose.

Study Arms (3)

High-dose Psilocybin

EXPERIMENTAL

Psilocybin 300 mcg/kg once per week, every week, for 8 weeks

Drug: Psilocybin 300 mcg/kg

High- or Low-dose Psilocybin

EXPERIMENTAL

Psilocybin 100 mcg/kg or psilocybin 300 mcg/kg once per week, every week, for 8 weeks

Drug: Psilocybin 100 mcg/kg; Drug: Psilocybin 300 mcg/kg

High-dose Psilocybin or Lorazepam

PLACEBO COMPARATOR

Psilocybin 300 mcg/kg or Lorazepam 1 mg once per week, every week, for 8 weeks

Drug: Psilocybin 300 mcg/kg; Drug: Lorazepam 1 mg

Interventions

Psilocybin 100 mcg/kg DRUG

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").

Also known as: Psilocybine, "magic mushrooms"

High- or Low-dose Psilocybin

Psilocybin 300 mcg/kg DRUG

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").

Also known as: Psilocybine, "magic mushrooms"

High- or Low-dose Psilocybin; High-dose Psilocybin; High-dose Psilocybin or Lorazepam

Lorazepam 1 mg DRUG

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).

Also known as: Ativan, Intensol

High-dose Psilocybin or Lorazepam

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

University of Arizona

Tucson, Arizona, 85724, United States

Location

Related Publications (1)

• 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. doi: 10.4088/jcp.v67n1110.

  PMID: 17196053 RESULT

Related Links

• PubMed Abstract Link

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Psilocybin; Lorazepam

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines; Benzodiazepinones; Benzodiazepines; Benzazepines

Study Officials

• Francisco A. Moreno, MD

  Professor of Psychiatry and Associate Vice President, Diversity and Inclusion

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Vice President, Diversity and Inclusion; Professor, Psychiatry

Model Details: 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.

Study Record Dates

• First Submitted: September 14, 2017
• First Posted: October 4, 2017
• Study Start: January 2, 2019
• Primary Completion: October 30, 2023
• Study Completion: December 30, 2023
• Last Updated: August 30, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)