Obsessive-Compulsive DisorderPhase 2NCT04978428
Epidiolex in Obsessive Compulsive Disorder and Related Disorders
A Phase 2 study testing Cannabidiol in people with Obsessive-Compulsive Disorder and Trichotillomania (Hair-Pulling Disorder), run by University of Chicago at 1 site in United States.
Trial summary
The primary objective of the proposed study is to evaluate the safety and efficacy of Epidiolex (cannabidiol) in adults with obsessive compulsive and related disorders (OCRDs). Subjects will be treated in an open-label fashion with Epidiolex for two weeks. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obsessive-Compulsive Disorder, Trichotillomania (Hair-Pulling Disorder), Tourette Syndrome
- What is being tested?
- Cannabidiol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2022to 1 Nov 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women age 18-65
- Primary diagnosis of OCD, Hoarding Disorder, Skin Picking Disorder, Trichotillomania, or Tourette Syndrome
- YBOCS score of at least 18 at baseline
- Ability to understand and sign the consent form.
Who cannot join
- Unstable medical illness based on history or clinically significant abnormalities on baseline physical examination or labs
- Current pregnancy or lactation, or inadequate contraception in women of childbearing potential
- Subjects considered an immediate suicide risk based on the Columbia Suicide Severity Rating Scale (C-SSRS)
- Past 12-month DSM-5 psychiatric disorder other than OCD
- Illegal substance use based on urine toxicology screening
- Initiation of psychological interventions within 3 months of screening
Show all 9Show fewer
- Use of any other psychotropic medication
- Previous treatment with Epidiolex
- Cognitive impairment that interferes with the capacity to understand and self-administer medication or provide written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label Trial of Epidiolex in the Treatment of Obsessive Compulsive Disorder and Related Disorders: Proof of Concept Study
The primary objective of the proposed study is to evaluate the safety and efficacy of Epidiolex (cannabidiol) in adults with obsessive compulsive and related disorders (OCRDs). Subjects will be treated in an open-label fashion with Epidiolex for two weeks.
Read the detailed description
The primary objective of the proposed study is to evaluate the safety and efficacy of Epidiolex (cannabidiol) in adults with obsessive compulsive and related disorders (OCRDs). OCRDs include obsessive compulsive disorder (OCD), trichotillomania, skin picking, tourettes disorder, and hoarding disorders. These disorders appear linked in terms of phenomenology and possibly biology. Fifteen subjects with OCRDs will be treated in an open-label fashion with Epidiolex (2.5 mg/kg twice daily for one week followed by 5mg/kg twice daily) for two total weeks of active treatment. The hypothesis to be tested is that Epidiolex will result in reduction in symptoms of OCRDs (improvement in symptoms will be indicated by lower scores on established outcome measures of OCRDs symptoms that have been used in prior studies).
- Conditions
- Obsessive-Compulsive Disorder, Trichotillomania (Hair-Pulling Disorder), Tourette Syndrome, Hoarding Disorder
- Being tested
- Cannabidiol
- Keywords
- Obsessive Compulsive Disorder, CBD, Hoarding, Tourettes, Trichotillomania, Skin Picking Disorder, Body focused repetitive behaviors
- Medical subject headings
- Obsessive-Compulsive Disorder, Trichotillomania, Tourette Syndrome, Hoarding Disorder, Hoarding, Excoriation Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabidiolDrug
Also called Epidiolex
Epidiolex oral solution (2.5 mg/kg and 5 mg/kg)
| Study group | Role | What they receive |
|---|---|---|
| Epidiolex | Experimental | Epidiolex (2.5 mg/kg twice daily for one week) followed by Epidiolex (5mg/kg twice daily for two weeks) Receives: Drug: Cannabidiol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Yale Brown Obsessive Compulsive Scale (YBOCS) Total Score
The primary outcome measure will be the change from baseline using the Yale Brown Obsessive Compulsive Scale (YBOCS). The YBOCS is a 10-item scale that assesses OCD symptoms during the last seven days. The first five items comprise the urge/thought subscale and items 6-10 comprise the behavior subscale. The change in scores from baseline to Week 2 will be reported. The scores from the subscales are summed together to reach a total score. The scale ranges from 0-40 with higher scores reflecting more severe symptoms.
Measured: Baseline to Week 2
Change in NIMH Symptom Severity Scale (for TTM or Skin Picking) Total Score
The primary efficacy measure will be the change in hair pulling or skin picking frequency and urges to pull hair or pick skin for the past week as indicated by change in total score. The entire study lasts two weeks. Every two weeks subjects will take the NIMH-TSS. The change in scores from baseline to Week 2 will be reported. The scale itself assesses severity of trichotillomania symptoms. The NIMH-TSS score ranges from 0 to 20, with 0 being no symptoms and 20 being the most severe.
Measured: Baseline to Week 2
Secondary outcomes (5)
Change in Clinical Global Impressions- Severity Scale (CGI-S) Total Score
The entire study for the subject will last 2 weeks. The subject will complete the CGI once per week. The change in scores from baseline to Week 2 will be reported. The scale itself assesses overall disorder severity on a scale from 1 to 7 with 1 being "not at all" and 7 being "among the most severe cases"
Measured: Baseline to Week 2
Change in Hamilton Depression Rating Scale (HAM-D) Total Score
The Hamilton Depression Rating Scale (HAM-D) is a clinician-administered assessment of depression that will be assessed at all study visits. The HAM-D is a 17-item scale that assess depressive symptoms during the last seven days. The change in scores from baseline to Week 2 will be reported. The scale ranges from 0-52 with higher total scores indicating higher levels of depression, while a score of 0 would indicate no depressive symptoms.
Measured: Baseline to Week 2
Change in Hamilton Anxiety Rating Scale (HAM-A) Total Score
The Hamilton Anxiety Rating Scale (HAM-A) is a clinician-administered assessment of anxiety that will be assessed at all study visits. The HAM-A is a 14 item scale that assess anxiety symptoms during the last fourteen days. The change in scores from baseline to Week 2 will be reported. The scale ranges from 0-56 with higher scores indicating higher levels of anxiety, with 0 being no symptoms of anxiety.
Measured: Baseline to Week 2
Change in Sheehan Disability Scale (SDS) Total Score
The Sheehan Disability Scale (SDS) is a self-report scale that subjects will complete the SDS at all visits. The SDS is a three item scale that measures functional impairment across work/school, social life, and family/home responsibilities during the past seven days. The change in scores from baseline to Week 2 will be reported. Each item ranges from 0-10, with higher scores indicating more impairment. However, only total score is reported which ranges from 0-30, with higher scores indicating more severe impairment. The total score is computed by summing the three scores from each domain. The scale itself assesses the level of disability from target disorder with higher scores indicating a more debilitating disorder.
Measured: Baseline to Week 2
Change in Quality of Life Inventory (QOLI) Total Score
The Quality of Life Inventory (QOLI) is a self-report assessment of patient perceived quality of life that will be assessed at each visit. The change in scores from baseline to Week 2 will be reported. The QOLI assesses both the importance and satisfaction of 16 life domains. Scores are calculated by multiplying the importance score by the satisfaction score which gives a weighted score for each domain. Each weighted score is then added together to get a total score which ranges from 0-100 with higher scores indicating a higher quality of life, whereas lower scores indicate a lower quality of life.
Measured: Baseline to Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start14 Apr 2022
- Primary completion1 Nov 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Obsessive-Compulsive DisorderStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open-Label treatment study
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jon E Grant, MD, JD, MPH, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04978428
- Sponsor's protocol ID
- IRB21-1147
- Status last verified
- Jun 2026
- First submitted
- 20 Jul 2021
- Last updated
- 29 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Blanco C, Olfson M, Stein DJ, Simpson HB, Gameroff MJ, Narrow WH. Treatment of obsessive-compulsive disorder by U.S. psychiatrists. J Clin Psychiatry. 2006 Jun;67(6):946-51. doi: 10.4088/jcp.v67n0611.
PubMed 16848654Bloch MH, Landeros-Weisenberger A, Kelmendi B, Coric V, Bracken MB, Leckman JF. A systematic review: antipsychotic augmentation with treatment refractory obsessive-compulsive disorder. Mol Psychiatry. 2006 Jul;11(7):622-32. doi: 10.1038/sj.mp.4001823. Epub 2006 Apr 4.
PubMed 16585942Frisch MB, Cornell J, Villaneuva M (1993). Clinical validation of the Quality of Life Inventory: a measure of life satisfaction for use in treatment planning and outcome assessment. Psychol Assess. 4:92-101.
Grant JE. Clinical practice: Obsessive-compulsive disorder. N Engl J Med. 2014 Aug 14;371(7):646-53. doi: 10.1056/NEJMcp1402176.
PubMed 25119610HAMILTON M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960 Feb;23(1):56-62. doi: 10.1136/jnnp.23.1.56. No abstract available.
PubMed 14399272HAMILTON M. The assessment of anxiety states by rating. Br J Med Psychol. 1959;32(1):50-5. doi: 10.1111/j.2044-8341.1959.tb00467.x. No abstract available.
PubMed 13638508Ravizza L, Barzega G, Bellino S, Bogetto F, Maina G. Predictors of drug treatment response in obsessive-compulsive disorder. J Clin Psychiatry. 1995 Aug;56(8):368-73.
PubMed 7635854Sheehan DV (1983). The Anxiety Disease. New York: Scribner's.
Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57.
PubMed 9881538
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Trial of Epidiolex in the Treatment of Obsessive Compulsive Disorder and Related Disorders: Proof of Concept Study
- ClinicalTrials.gov ID
- NCT04978428
- Acronym / sponsor ID
- IRB21-1147
- Conditions
- Obsessive-Compulsive Disorder, Trichotillomania (Hair-Pulling Disorder), Tourette Syndrome, Hoarding Disorder
- Keywords
- Obsessive Compulsive Disorder, CBD, Hoarding, Tourettes, Trichotillomania, Skin Picking Disorder, Body focused repetitive behaviors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 14 Apr 2022 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 27 Jul 2021 (actual)
- Results
- Posted 29 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the proposed study is to evaluate the safety and efficacy of Epidiolex (cannabidiol) in adults with obsessive compulsive and related disorders (OCRDs). Subjects will be treated in an open-label fashion with Epidiolex for two weeks.
Detailed description
The primary objective of the proposed study is to evaluate the safety and efficacy of Epidiolex (cannabidiol) in adults with obsessive compulsive and related disorders (OCRDs). OCRDs include obsessive compulsive disorder (OCD), trichotillomania, skin picking, tourettes disorder, and hoarding disorders. These disorders appear linked in terms of phenomenology and possibly biology. Fifteen subjects with OCRDs will be treated in an open-label fashion with Epidiolex (2.5 mg/kg twice daily for one week followed by 5mg/kg twice daily) for two total weeks of active treatment. The hypothesis to be tested is that Epidiolex will result in reduction in symptoms of OCRDs (improvement in symptoms will be indicated by lower scores on established outcome measures of OCRDs symptoms that have been used in prior studies).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open-Label treatment study
| Arm | Type | Receives |
|---|---|---|
| Epidiolex | Experimental | Drug: CannabidiolEpidiolex (2.5 mg/kg twice daily for one week) followed by Epidiolex (5mg/kg twice daily for two weeks) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women age 18-65
- Primary diagnosis of OCD, Hoarding Disorder, Skin Picking Disorder, Trichotillomania, or Tourette Syndrome
- YBOCS score of at least 18 at baseline
- Ability to understand and sign the consent form.
Key exclusion criteria (9 listed)
- Unstable medical illness based on history or clinically significant abnormalities on baseline physical examination or labs
- Current pregnancy or lactation, or inadequate contraception in women of childbearing potential
- Subjects considered an immediate suicide risk based on the Columbia Suicide Severity Rating Scale (C-SSRS)
- Past 12-month DSM-5 psychiatric disorder other than OCD
- Illegal substance use based on urine toxicology screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CannabidiolAlso: EpidiolexEpidiolex oral solution (2.5 mg/kg and 5 mg/kg) | Drug | Epidiolex |
Primary outcome
Change in Yale Brown Obsessive Compulsive Scale (YBOCS) Total Score
Time frame: Baseline to Week 2
The primary outcome measure will be the change from baseline using the Yale Brown Obsessive Compulsive Scale (YBOCS). The YBOCS is a 10-item scale that assesses OCD symptoms during the last seven days. The first five items comprise the urge/thought subscale and items 6-10 comprise the behavior subscale. The change in scores from baseline to Week 2 will be reported. The scores from the subscales are summed together to reach a total score. The scale ranges from 0-40 with higher scores reflecting more severe symptoms.
Change in NIMH Symptom Severity Scale (for TTM or Skin Picking) Total Score
Time frame: Baseline to Week 2
The primary efficacy measure will be the change in hair pulling or skin picking frequency and urges to pull hair or pick skin for the past week as indicated by change in total score. The entire study lasts two weeks. Every two weeks subjects will take the NIMH-TSS. The change in scores from baseline to Week 2 will be reported. The scale itself assesses severity of trichotillomania symptoms. The NIMH-TSS score ranges from 0 to 20, with 0 being no symptoms and 20 being the most severe.
5 secondary outcomes
Change in Clinical Global Impressions- Severity Scale (CGI-S) Total Score
Time frame: Baseline to Week 2
Change in Hamilton Depression Rating Scale (HAM-D) Total Score
Time frame: Baseline to Week 2
Change in Hamilton Anxiety Rating Scale (HAM-A) Total Score
Time frame: Baseline to Week 2
Change in Sheehan Disability Scale (SDS) Total Score
Time frame: Baseline to Week 2
Change in Quality of Life Inventory (QOLI) Total Score
Time frame: Baseline to Week 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16848654Blanco C, Olfson M, Stein DJ, Simpson HB, Gameroff MJ, Narrow WH. Treatment of obsessive-compulsive disorder by U.S. psychiatrists. J Clin Psychiatry. 2006 Jun;67(6):946-51. doi: 10.4088/jcp.v67n0611.
- Background: PubMed 16585942Bloch MH, Landeros-Weisenberger A, Kelmendi B, Coric V, Bracken MB, Leckman JF. A systematic review: antipsychotic augmentation with treatment refractory obsessive-compulsive disorder. Mol Psychiatry. 2006 Jul;11(7):622-32. doi: 10.1038/sj.mp.4001823. Epub 2006 Apr 4.
- BackgroundFrisch MB, Cornell J, Villaneuva M (1993). Clinical validation of the Quality of Life Inventory: a measure of life satisfaction for use in treatment planning and outcome assessment. Psychol Assess. 4:92-101.
- Background: PubMed 25119610Grant JE. Clinical practice: Obsessive-compulsive disorder. N Engl J Med. 2014 Aug 14;371(7):646-53. doi: 10.1056/NEJMcp1402176.
- Background: PubMed 14399272HAMILTON M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960 Feb;23(1):56-62. doi: 10.1136/jnnp.23.1.56. No abstract available.
- Background: PubMed 13638508HAMILTON M. The assessment of anxiety states by rating. Br J Med Psychol. 1959;32(1):50-5. doi: 10.1111/j.2044-8341.1959.tb00467.x. No abstract available.
- Background: PubMed 7635854Ravizza L, Barzega G, Bellino S, Bogetto F, Maina G. Predictors of drug treatment response in obsessive-compulsive disorder. J Clin Psychiatry. 1995 Aug;56(8):368-73.
- BackgroundSheehan DV (1983). The Anxiety Disease. New York: Scribner's.
- Background: PubMed 9881538Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jon E Grant, MD, JD, MPH principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cannabidiol in people with Obsessive-Compulsive Disorder and Trichotillomania (Hair-Pulling Disorder), run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Yale Brown Obsessive Compulsive Scale (YBOCS) Total Score (time frame: Baseline to Week 2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04978428, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.