TrichotillomaniaPhase 2NCT01093976
Marinol in Trichotillomania or Obsessive Compulsive Disorder
A Phase 2 study testing Dronabinol in people with Trichotillomania and Obsessive Compulsive Disorder, run by University of Chicago at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Trichotillomania, Obsessive Compulsive Disorder
- What is being tested?
- Dronabinol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Feb 2011
- 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
- Age 18-65 years
- Obsessive-compulsive disorder (OCD), Trichotillomania (TTM), or Pathological Skin Picking (PSP) as the primary psychiatric diagnosis
- (If OCD) - Subject reports ≥two failed treatments using selective serotonin reuptake inhibitors (SSRIs) for their OCD
- Women's participation required negative results on a beta-human chorionic gonadotropin pregnancy test and stable use of a medically accepted form of contraception.
- Signed informed consent before entry into the study.
Who cannot join
- Unstable medical illness or clinically significant abnormalities on laboratory tests or physical examination at screening visit
- Current pregnancy or lactation, or inadequate contraception in women of childbearing potential
- A need for medication other than dronabinol with possible psychotropic effects
- History of hypersensitivity to any cannabinoid or sesame oil
- Lifetime history of bipolar disorder type I or II, dementia, or schizophrenia as determined by the Structured Clinical Interview for DSM-IV
- Current (past 12-months) DSM-IV substance abuse or dependence
Show all 11Show fewer
- Positive urine drug screen at screening
- Initiation of cognitive behavior therapy within 3 months prior to study baseline
- Baseline score of ≥ 17 on the Hamilton Depression Rating Scale (17-item HDRS
- Suicidality based on clinical interview
- History of head injury or neurological disorder (such as seizures)
Trial locations and contacts
1 site in 1 country.
United States1 site
Ambulatory Research Center
Minneapolis, Minnesota, 55454
About this study
Official title: An Open-Label Study of Dronabinol, a Cannabinoid Agonist, for Obsessive Compulsive Disorder and the Obsessive-Compulsive Spectrum Disorders Trichotillomania and Pathological Skin Picking
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.
Read the detailed description
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.
- Conditions
- Trichotillomania, Obsessive Compulsive Disorder
- Being tested
- Dronabinol
- Keywords
- Skin Picking, OCD, Trichotillomania, Pathological Skin Picking
- Medical subject headings
- Trichotillomania, Obsessive-Compulsive Disorder, Excoriation Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DronabinolDrug
Also called MARINOL
2.5mg-15mg by mouth once a day for twelve-weeks
| Study group | Role | What they receive |
|---|---|---|
| Dronabinol | Experimental | Dronabinol (Marinol) - 2.5mg-15mg by mouth once a day for twelve-weeks Receives: Drug: Dronabinol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Subjects were followed for their duration of participation in the study (12-weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2010 (estimated)
- Study startApr 2010
- Primary completionJan 2011
- Study completionFeb 2011
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 (1)Papers the sponsor has linked to this study.
- Other trials for TrichotillomaniaStudies 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
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jon E Grant, JD, MD, MPH, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01093976
- Sponsor's protocol ID
- 0909M72088
- Status last verified
- Feb 2023
- First submitted
- 24 Mar 2010
- Last updated
- 23 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 21590520
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study of Dronabinol, a Cannabinoid Agonist, for Obsessive Compulsive Disorder and the Obsessive-Compulsive Spectrum Disorders Trichotillomania and Pathological Skin Picking
- ClinicalTrials.gov ID
- NCT01093976
- Acronym / sponsor ID
- 0909M72088
- Conditions
- Trichotillomania, Obsessive Compulsive Disorder
- Keywords
- Skin Picking, OCD, Trichotillomania, Pathological Skin Picking
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 26 Mar 2010 (estimated)
- Results
- Posted 27 Sep 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dronabinol | Experimental | Drug: DronabinolDronabinol (Marinol) - 2.5mg-15mg by mouth once a day for twelve-weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-65 years
- Obsessive-compulsive disorder (OCD), Trichotillomania (TTM), or Pathological Skin Picking (PSP) as the primary psychiatric diagnosis
- (If OCD) - Subject reports ≥two failed treatments using selective serotonin reuptake inhibitors (SSRIs) for their OCD
- Women's participation required negative results on a beta-human chorionic gonadotropin pregnancy test and stable use of a medically accepted form of contraception.
- Signed informed consent before entry into the study.
Key exclusion criteria (11 listed)
- Unstable medical illness or clinically significant abnormalities on laboratory tests or physical examination at screening visit
- Current pregnancy or lactation, or inadequate contraception in women of childbearing potential
- A need for medication other than dronabinol with possible psychotropic effects
- History of hypersensitivity to any cannabinoid or sesame oil
- Lifetime history of bipolar disorder type I or II, dementia, or schizophrenia as determined by the Structured Clinical Interview for DSM-IV
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 |
|---|---|---|
| DronabinolAlso: MARINOL2.5mg-15mg by mouth once a day for twelve-weeks | Drug | Dronabinol |
Primary outcome
Massachusetts General Hospital Hairpulling Scale (MGH-HPS) Total Score
Time frame: Subjects were followed for their duration of participation in the study (12-weeks)
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21590520Grant 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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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, JD, MD, MPH principal investigator
University of Minnesota
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 Dronabinol in people with Trichotillomania and Obsessive Compulsive 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 5 inclusion and 11 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 23 Feb 2023. 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 27 Sep 2013). 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?
Massachusetts General Hospital Hairpulling Scale (MGH-HPS) Total Score (time frame: Subjects were followed for their duration of participation in the study (12-weeks)). 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 NCT01093976, which also lists 1 linked publication.
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 23 Feb 2023.