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The goal of the proposed study is to evaluate the efficacy and safety of dronabinol in individuals with obsessive-compulsive disorder (OCD) or the obsessive-compulsive spectrum disorders, trichotillomania (TTM) or pathological skin picking (PSP). Fifteen patients with OCD, TTM, or PSP will receive 12 weeks of open-label treatment with dronabinol. The hypothesis to be tested is that dronabinol will be effective and well tolerated in patients with these disorders. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.
The study consists of twelve weeks of open-label dronabinol. All eligible study subjects will be started on open-label dronabinol 2.5mg/day for 3 weeks. The dose will be increased to 5mg/day at visit 2 (Week 3), to10mg/day at visit 3 (Week 6), and to 15mg/day at Visit 4 (Week 9) unless clinical improvement is attained at a lower dose (clinical improvement will be assessed by the investigator with respect to obsessive thoughts, urges and compulsive behaviors). Subjects will be seen every three weeks during the 12-week, open-label study. All efficacy and safety assessments will be performed at each visit. Subjects who are not compliant with their use of study medication (i.e. failing to take medication for three or more consecutive days) will be discontinued from the study.
Laboratory testing, including liver function tests, a blood chemistry panel, and urine toxicology will be completed for subjects at baseline if in the opinion of the study physician the medical history of the subject warrants such tests for their safety. All females, regardless of age, will undergo a urine pregnancy test at screening and all subjects will be required to do a urine drug screen at the screening visit to test for drugs of abuse.
At study conclusion, subjects will be given the option to continue on medication (via prescription) if covered by insurance, and will then be followed in our clinic or referred to another psychiatrist. All study subjects will be offered follow-up care with CBT and/or medication in our outpatient clinic (if covered by insurance) or be given a list of appropriate referrals in the community.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dronabinol | Experimental | Dronabinol (Marinol) - 2.5mg-15mg by mouth once a day for twelve-weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dronabinol | Drug | 2.5mg-15mg by mouth once a day for twelve-weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Massachusetts General Hospital Hairpulling Scale (MGH-HPS) Total Score | The MGH-HPS is a 7-item, self-report scale that rates urges to pull hair, actual amount of pulling, perceived control over behavior, and distress associated with hair pulling over the past seven days. Total possible score is a 28 indicating the highest level of severity out of a scale from 0-28. | Subjects were followed for their duration of participation in the study (12-weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jon E Grant, JD, MD, MPH | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ambulatory Research Center | Minneapolis | Minnesota | 55454 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21590520 | Derived | Grant JE, Odlaug BL, Chamberlain SR, Kim SW. Dronabinol, a cannabinoid agonist, reduces hair pulling in trichotillomania: a pilot study. Psychopharmacology (Berl). 2011 Dec;218(3):493-502. doi: 10.1007/s00213-011-2347-8. Epub 2011 May 19. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dronabinol | Dronabinol (Marinol) - 2.5mg-15mg by mouth once a day for twelve-weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dronabinol | Dronabinol (Marinol) - 2.5mg-15mg by mouth once a day for twelve-weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Massachusetts General Hospital Hairpulling Scale (MGH-HPS) Total Score | The MGH-HPS is a 7-item, self-report scale that rates urges to pull hair, actual amount of pulling, perceived control over behavior, and distress associated with hair pulling over the past seven days. Total possible score is a 28 indicating the highest level of severity out of a scale from 0-28. | Mean score reported below is the endpoint MGH-HPS score (at 12-weeks or last-observation carried forward). | Posted | Mean | Standard Deviation | units on a scale | Subjects were followed for their duration of participation in the study (12-weeks) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dronabinol | Dronabinol (Marinol) - 2.5mg-15mg by mouth once a day for twelve-weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Light-headed / dizziness | Psychiatric disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jon E. Grant | University of Minnesota | 612-273-9800 | grant045@umn.edu |
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| ID | Term |
|---|---|
| D014256 | Trichotillomania |
| D009771 | Obsessive-Compulsive Disorder |
| D000096705 | Excoriation Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
| D007174 | Disruptive, Impulse Control, and Conduct Disorders |
| D016728 | Self-Injurious Behavior |
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| ID | Term |
|---|---|
| D013759 | Dronabinol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| 0 |
| 14 |
| 4 |
| 14 |
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| D001526 | Behavioral Symptoms |
| D001519 | Behavior |