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Synthetic Cannabinoid

Nabilone for Obsessive-Compulsive Disorder

Phase 1 & 2
Recruiting
Led By Reilly Kayser, MD
Research Sponsored by New York State Psychiatric Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Between 21-55 years of age
Not taking psychotropic medications or other substances likely to interact with nabilone
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study Summary

This trial will test how well a medication called nabilone works for treating symptoms of OCD, including how it affects threat response, processing of fear signals, and habitual behavior.

Who is the study for?
This trial is for right-handed adults aged 21-55 with a primary diagnosis of OCD, who are physically healthy and not on psychotropic meds or substances that affect nabilone. Pregnant women can't join. Participants must be able to undergo all study procedures and provide consent.Check my eligibility
What is being tested?
The study tests the effect of nabilone, a synthetic THC-like drug, on neurocognitive processes in OCD versus placebo. It involves one-time dosing followed by assessments like neuroimaging and behavioral tasks to potentially develop new treatments.See study design
What are the potential side effects?
Nabilone may cause psychoactive effects similar to cannabis (like altered perception), dizziness, dry mouth, or sleepiness. Since it's being compared with a placebo, some participants won't experience any active drug side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 21 and 55 years old.
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I am not on medications that could affect nabilone treatment.
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I am in good health and not pregnant.
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My primary diagnosis is OCD.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Brain Measure 1
Brain Measure 2
Electromyography (EMG)
+2 more
Secondary outcome measures
Blood pressure
Drug Effects Questionnaire (DEQ)
End of Session Questionnaire (ESQ)
+7 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: NabiloneActive Control1 Intervention
In a randomized, double-blind, placebo-controlled design, we will administer a one-time oral dose of nabilone (1mg) or placebo approximately two hours prior to fMRI scanning and task performance in 60 adults with OCD.
Group II: PlaceboPlacebo Group1 Intervention
In a randomized, double-blind, placebo-controlled design, we will administer a one-time oral dose of nabilone (1mg) or placebo approximately two hours prior to fMRI scanning and task performance in 60 adults with OCD.

Find a Location

Who is running the clinical trial?

New York State Psychiatric InstituteLead Sponsor
475 Previous Clinical Trials
153,847 Total Patients Enrolled
24 Trials studying Obsessive-Compulsive Disorder
887 Patients Enrolled for Obsessive-Compulsive Disorder
National Institute of Mental Health (NIMH)NIH
2,786 Previous Clinical Trials
2,689,707 Total Patients Enrolled
65 Trials studying Obsessive-Compulsive Disorder
13,921 Patients Enrolled for Obsessive-Compulsive Disorder
Reilly Kayser, MDPrincipal InvestigatorColumbia University/New York State Psychiatric Institute

Media Library

Nabilone (Synthetic Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT04880278 — Phase 1 & 2
Obsessive-Compulsive Disorder Research Study Groups: Nabilone, Placebo
Obsessive-Compulsive Disorder Clinical Trial 2023: Nabilone Highlights & Side Effects. Trial Name: NCT04880278 — Phase 1 & 2
Nabilone (Synthetic Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04880278 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this study recruiting patients that are over 45 years old?

"The age bracket for participants in this study are those who have turned 21 but are yet to reach their 55th birthday."

Answered by AI

How many individuals are taking part in this experiment at most?

"The information on clinicialtrials.gov indicates that this trial is actively recruiting patients. The trial was first posted on March 1, 2022 and was last updated on March 29, 2022. The study is looking for 60 patients across 1 sites."

Answered by AI

What are researchers hoping to find out through this experiment?

"The primary outcome that will be used to gauge the success of this five-year clinical trial is Expectancy Ratings. Additionally, researchers will also track Secondary outcomes which include Subjective Units of Distress (SUDS), Heart rate, and Yale-Brown Obsessive-Compulsive Challenge Scale."

Answered by AI

How can I sign up for this experiment?

"Researchers are looking for 60 participants that suffer from OCD and meet the following requirements: Able to participate in all study procedures, Not currently taking medication or other substances that would interact with nabilone, Physically healthy, Female patients must not be pregnant, Must be right-handed."

Answered by AI

What other scientific research studies have there been on Nabilone?

"At this moment, there are 6 Nabilone trials underway with 3 of them being Phase 3 clinical trials. Many of the research sites for Nabilone are in Toronto, Ontario; however, treatment is also taking place at 9 other locations."

Answered by AI

Are there any participants needed for this research project at the moment?

"That is correct, the website clinicaltrials.gov has updated information saying that this trial is still admitting patients. The first posting was on March 1st, 2022 and the last update was on March 29th, 2022. They are looking for a total of 60 individuals from 1 site."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
What site did they apply to?
New York State Psychiatric Institute
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Multimodal Assessment of Cannabinoid Target Engagement in Adults With Obsessive-Compulsive Disorder
Reilly R. Kayser 2022. "Multimodal Assessment of Cannabinoid Target Engagement in Adults With Obsessive-Compulsive Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04880278.
All > Obsessive Compulsive Disorder > Ocd
~30 spots leftby Jul 2026
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