Health TrialsbyHealthPanel

Psilocybin Whole Mushroom for the Treatment of Obsessive-compulsive Disorder.

ConditionObsessive-Compulsive Disorder
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorFrancisco A Moreno

About this trial

The study tries to improve our treatments for people who have obsessive-compulsive disorder (OCD) by testing psilocybin, a mind altering drug that changes activity in brain areas involved in OCD. 30 patients with moderate or more severe OCD who are not taking mind altering medications or street drugs will participate in a 12 week study. Participants will be assigned (by luck of the draw) to take a low, medium, or high dose whole psilocybin mushroom contained in three chocolate pieces, prepared for this study by the Scottsdale Research Institute.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18 years old, and older

Have OCD (DSM-5) based on diagnostic interview using the Structured Clinical Interview for DSM-5 Research Version (SCID).

At least moderate severity: Yale-Brown Obsessive Compulsive Scale (YBOCS) score ≥16.

Failed at least one adequate trial of guideline concordant treatment.

Disqualifiers

Concurrent active substance use disorder, or a personal history of psychosis.

History of psychosis among first degree relatives as determined by the Family Interview for Genetic Studies (FIGS)32

Medical illness based on physical examination and routine blood testing that may complicate cardiovascular safety or drug metabolism or excretion. Examples include: 1) Cardiovascular conditions: lifetime history of stroke, lifetime myocardial infarction, uncontrolled hypertension (resting blood pressure >140/90 mmHg), tachycardia (resting heart rate >100 beats per minute), elongated QT interval corrected by Fridericia's formula (QTcF; interval >450 msec), participants with existing valvular heart disease, or clinically significant arrhythmia (<1 year prior to signing the ICF); 2) Metabolic conditions: subjects with diabetes should have a stable diabetes treatment regimen and no history of diabetic ketoacidosis, hyperglycemic coma, or no hypoglycemic episodes with glucose below 54 mg/dL in the 3 months prior to baseline, and fasting glucose >70 mg/dL at baseline; 3) Severe renal impairment: eGFR <45 mL/min/1.73 m²); and Liver failure: Child-Pugh Classes B and C.

Unstable Chronic Obstructive Pulmonary Disease (COPD) or severe sleep apnea

Trial design

Design model

Parallel

Treatments tested in this trial

  • Psilocybin 10 mg

    Drug

    Oral administration of whole dried psilocybin mushrooms contained in a chocolate matrix.

  • Psilocybin 20 mg

    Drug

    Oral administration of whole dried psilocybin mushrooms contained in a chocolate matrix.

  • Psilocybin 30 mg

    Drug

    Oral administration of whole dried psilocybin mushrooms contained in a chocolate matrix.

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: Low dose 10 mgExperimental treatment 1 intervention
Group B: Middle dose 20 mgExperimental treatment 1 intervention
Group C: High dose 30 mgExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Yale Brown Obsessive Compulsive Scale

Clinician rating scale to determine severity of OCD symptoms. Scores vary from 0 to 40. Higher scores represent greater severity of OCD symptoms.

Time frame
Baseline, Weekly for 12 weeks (Treatment phase), and Monthly for 12 month (Follow up phase).
2

Adverse Event (AE) Tracking log

The Adverse Event tracking log will collect information on adverse health events reported throughout the research study.

Time frame
Weekly for 12 weeks (Treatment phase), and Monthly for 12 month (Follow up phase).
3

Visual Analogue Scale (VAS)

Self-reported measure of intensity or frequency of pain or other various symptoms

Time frame
Baseline, Weekly for 12 weeks (Treatment phase), and Monthly for 12 month (Follow up phase). Scale 0 (no symptoms at all) to 100 (maximum symptom severity)

Secondary outcomes

1

World Health Organization's quality of life assessment (WHOQOL-BREF)

A 26-item psychometric questionnaire to measure quality of life and functional ability. Raw scores are converted to transformed scores in four health related domains. Higher scores represent higher quality of life.

Time frame
Baseline, Weekly for 12 weeks (Treatment phase), and Monthly for 12 month (Follow up phase).
2

Short form health survey (SF-36)

Subject self-reporting health survey to monitor and assess functional impairment

Time frame
Baseline, Weekly for 12 weeks (Treatment phase), and Monthly for 12 month (Follow up phase). Functionality scales are transformed to range from 0 to 100 with 0 being maximal disability and 100 being no disability.
3

Columbia-Suicide Severity Rating Scale (C-SSRS)

A suicide risk assessment tool for prospective monitoring of suicidal ideation and behavior.

Time frame
Baseline, Weekly for 12 weeks (Treatment phase), and Monthly for 12 month (Follow up phase). Individuals with positive ideation or behavior scores can be categorized into low, moderate or high risk of suicide.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Francisco A Moreno

Lead sponsor

University of Arizona

Sponsor institution

Arizona Biomedical Research Commission (ABRC)

Collaborator

Source ClinicalTrials.gov
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