Psilocybin-assisted psychotherapy for severe OCD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Beer Sheva Mental Health Center
  Beersheba, Israel Recruiting

Study contacts

• Principal investigator: Oded Arbel, MD — Beersheva Mental Health Center
• Study coordinator: Oded Arbel, Dr.
• Email: oded.arbel@gmail.com
• Phone: +972506576691

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Low-intensity focused ultrasound targeting the subthalamic nucleus for OCD

  A short test is being done to see if a wearable, non-invasive ultrasound device can safely and tolerably help adults with OCD by targeting a brain region called the subthalamic nucleus.

  Recruiting Phase 2 University of Pennsylvania · Philadelphia, Pennsylvania · NCT07887633

• Mindfulness-Based Cognitive Therapy for OCD Delivered Online

  This study tests a synchronous online MBCT program for adults with OCD to see if it is acceptable and feasible and to explore links between biological markers, OCD severity, and treatment response.

  Recruiting IRCCS Centro San Giovanni di Dio Fatebenefratelli · Brescia · NCT07834567

• Targeted brain stimulation for OCD: test of tTIS on nucleus accumbens

  This study tests whether targeted temporal interference stimulation of the nucleus accumbens can help reduce obsessive-compulsive symptoms in adults with OCD, compared with sham stimulation.

  Recruiting Beijing HuiLongGuan Hospital · Hefei, Anhui · NCT07805200

• Anxiety Skills Study: See if video skill training plus therapy helps people with anxiety

  This study tests whether a brief video-based skill training can help people with anxiety as well as four therapy sessions, and how durable the effects are over a year.

  Recruiting Ohio State University · Columbus, Ohio · NCT07774481

• AttunE LIFU for OCD: a non-invasive brain stimulation study

  This trial tests ATTN201, a wearable ultrasound headband, to see if it helps adults with OCD compared to a sham treatment.

  Recruiting Phase 2 University of Pennsylvania · San Francisco, California · NCT07728994

• Combined ERP and Habit Reversal Therapy for Tourettic OCD

  This study tests whether a merged Exposure and Response Prevention and Habit Reversal Therapy helps adults with Tourettic OCD more than either therapy alone or basic psychoeducation.

  Recruiting at 2 sites University College London Hospitals · London, London and 1 other locations · NCT07725926

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.