Psilocybin-assisted psychotherapy for severe OCD

Open Label, Phase 2 Study for Evaluating the Feasibility, Safety and Efficacy of Psychotherapy Assisted Psilocybin for Treatment of Severe Obsessive Compulsive Disorder (OCD) in Drug and/or Psychotherapy Resistant Patients.

This study is testing whether combining therapy with psilocybin can help people with severe OCD who haven't found relief from regular treatments.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Beersheva Mental Health Center (Government)
• Locations: 1 site (Beersheba)
• Trial ID: NCT04882839 on ClinicalTrials.gov

What this trial studies

This study investigates the feasibility, safety, and efficacy of using psychotherapy combined with psilocybin to treat severe obsessive-compulsive disorder (OCD). It aims to provide an alternative treatment option for patients who have not responded to traditional therapies. The study involves 15 therapeutic sessions, focusing on the potential benefits of psilocybin in reducing OCD symptoms. Previous research has indicated that psilocybin may effectively alleviate anxiety and depression, making it a promising candidate for OCD treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with a DSM-5 diagnosis of OCD who have not responded to standard treatments.

Not a fit: Patients who have not been diagnosed with OCD or those who have not failed previous treatment options may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could offer a new, effective treatment option for patients suffering from severe OCD.

How similar studies have performed: While only one previous study has evaluated psilocybin for OCD, other studies have shown promising results for psilocybin in treating anxiety and depression.

Eligibility criteria

Inclusion Criteria:

* 1\. DSM-5 diagnosis of OCD established by a trained clinician interview and confirmed by Mini International Neuropsychiatric Interview MINI (edition 7).

  2\. Y-BOCS score of 16 or greater at evaluation 3. Treatment resistant- Patients; must have failed at least one medication and/or therapy trial of standard care treatment for OCD.

  4\. Age: 18 Years to 65 Years 5. Has been off selective serotonin inhibitors for five half-lives of the drug plus 2 weeks.

  6\. Must avoid starting new psychotherapy or psychiatric (medical) treatment during the study, without consulting the study team.

  7\. Are willing to refrain from taking any psychiatric medications or recreational drugs during the study period.

  8\. Must have a negative pregnancy test at study entry and prior to each experiential/ psychedelic session, if able to bear children, and must agree to use adequate birth control.

  9\. Must be willing to sign a medical release form for the investigators to communicate directly with their therapist and doctors to confirm a medication and/or medical history. This is decided on a case by case basis upon the discretion of the PI.

  10\. Must provide a contact (relative, spouse, close friend, or other caregiver) who is willing and able to be reached by the Clinical Investigators in the event of a participant becoming suicidal or any another relevant reason.

  11\. Are willing to commit to medication dosing, experiential/ psychedelic sessions, psychotherapy and follow-up sessions and to complete the full evaluation.

Exclusion Criteria:

* 1\. Personal or immediate family history of schizophrenia, bipolar affective disorder, delusion disorder, paranoid disorder, or schizoaffective disorder.

  2\. Current (or last 12-month) substance abuse disorder. 3. Unstable neurological or medical condition. 4. Active suicidal intent or last 12-month suicidal attempt. 5. A history of violence, self-harm, or harm to another. 6. Any unstable medical condition that may render study procedures unsafe. 7. Positive urine pregnancy test at the time of screening. 8. Any use of psychedelic drugs within the prior 12 months. 9. Lack of ability to sign Informed consent. Exclusion Criteria during the study
  1. Any unusual reaction to any of the study procedures.
  2. A participant's request to stop his/ her participation in the study.
  3. Positive pregnancy test at any stage prior to the last psychedelic session

Where this trial is running

Beersheba

• Beer Sheva Mental Health Center — Beersheba, Israel (Recruiting)

Study contacts

• Principal investigator: Oded Arbel, MD — Beersheva Mental Health Center
• Study coordinator: Oded Arbel, Dr.

Conditions Obsessive-compulsive Disorder; obsessive compulsive disorder; psilocybin