Psilocybin for Treatment of OCD-2

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFrancisco A Moreno

About this trial

Previous research indicates that psilocybin, a drug that changes activity in brain areas believed to be involved in obsessive-compulsive disorder (OCD), might improve treatment for, and improve lives of, people diagnosed with OCD. The investigators propose to study 20 patients with symptomatic OCD who are not taking mind altering medications or street drugs, to participate in a 12 week study. Participants will be assigned (by luck of the draw) to take low or high dose psilocybin in four dosing sessions separated by 3 weeks. Measurements for the severity of OCD, ability to function, perception of quality of life, safety and tolerability will be measured at baseline prior to drug administration, during the dosing periods, and at the end of study. Other measurements will include brain imaging via fMRI and brain tracing via electroencephalogram (EEG). The investigators believe that during medically supervised dosing sessions, both doses of psilocybin will be safe and well tolerated, and will reduce OCD symptoms. Because psilocybin is a potent drug and especially at the higher dose may induce altered states of consciousness, a thoughtfully implemented procedure for participant safety is in place. Information will be obtained to explore the effects of altered states of consciousness in the outcome of treatment and to find the mechanism of benefit.

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, such as uncontrolled hypertension, severe cardiac disease, or kidney or liver failure.

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Low Dose Psilocybin

    Drug

    10mg dose of psilocybin

  • High Dose Psilocybin

    Drug

    30mg dose of psilocybin

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Low Dose psilocybin (10mg)Active comparator 1 intervention
Group B: High dose psilocybin (30mg)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Safety and tolerability of orally administered psilocybin

Determine the acute safety and tolerability of orally administered psilocybin at low dose (10mg) and high dose (30mg) as measured with the Systematic Assessment for Treatment Emergent Events (SAFTEE) scale.

Time frame
12 months

Secondary outcomes

1

Efficacy of oral administered psilocybin in patient with OCD

Determine the efficacy of two different doses (10mg and 30mg) of psilocybin as a treatment for OCD, and explore whether there may be a dose-response relationship. This will be based on the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score.

Time frame
12 months

Other outcomes

1

Impact of psilocybin administration in brain function

Determine the impact of psilocybin administration in potential brain function OCD biomarkers

Time frame
12 months

Sponsors and contacts

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

Francisco A Moreno

Lead sponsor

University of Arizona

Sponsor institution

University of Arizona

Collaborator

This trial is not recruiting at the moment. You can still explore other options: