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Trial record 2 of 2 for:    "Trichotillomania" | "Hormones, Hormone Substitutes, and Hormone Antagonists"

Marinol in Trichotillomania or Obsessive Compulsive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01093976
Recruitment Status : Completed
First Posted : March 26, 2010
Results First Posted : September 27, 2013
Last Update Posted : September 27, 2013
Information provided by (Responsible Party):
Jon Grant, University of Chicago

Brief 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). 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.

Condition or disease Intervention/treatment Phase
Trichotillomania Obsessive Compulsive Disorder Drug: Dronabinol Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : April 2010
Actual Primary Completion Date : January 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Dronabinol

Arm Intervention/treatment
Experimental: Dronabinol
Dronabinol (Marinol) - 2.5mg-15mg by mouth once a day for twelve-weeks
Drug: Dronabinol
2.5mg-15mg by mouth once a day for twelve-weeks
Other Name: MARINOL

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age 18-65 years
  2. Obsessive-compulsive disorder (OCD), Trichotillomania (TTM), or Pathological Skin Picking (PSP) as the primary psychiatric diagnosis
  3. (If OCD) - Subject reports ≥two failed treatments using selective serotonin reuptake inhibitors (SSRIs) for their OCD
  4. Women's participation required negative results on a beta-human chorionic gonadotropin pregnancy test and stable use of a medically accepted form of contraception.
  5. Signed informed consent before entry into the study.

Exclusion Criteria:

  1. Unstable medical illness or clinically significant abnormalities on laboratory tests or physical examination at screening visit
  2. Current pregnancy or lactation, or inadequate contraception in women of childbearing potential
  3. A need for medication other than dronabinol with possible psychotropic effects
  4. History of hypersensitivity to any cannabinoid or sesame oil
  5. Lifetime history of bipolar disorder type I or II, dementia, or schizophrenia as determined by the Structured Clinical Interview for DSM-IV
  6. Current (past 12-months) DSM-IV substance abuse or dependence
  7. Positive urine drug screen at screening
  8. Initiation of cognitive behavior therapy within 3 months prior to study baseline
  9. Baseline score of ≥ 17 on the Hamilton Depression Rating Scale (17-item HDRS
  10. Suicidality based on clinical interview
  11. History of head injury or neurological disorder (such as seizures)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01093976

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United States, Minnesota
Ambulatory Research Center
Minneapolis, Minnesota, United States, 55454
Sponsors and Collaborators
University of Chicago
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Principal Investigator: Jon E Grant, JD, MD, MPH University of Minnesota - Clinical and Translational Science Institute

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Jon Grant, Professor of Psychiatry, University of Chicago Identifier: NCT01093976     History of Changes
Other Study ID Numbers: 0909M72088
First Posted: March 26, 2010    Key Record Dates
Results First Posted: September 27, 2013
Last Update Posted: September 27, 2013
Last Verified: August 2013

Keywords provided by Jon Grant, University of Chicago:
Skin Picking
Pathological Skin Picking

Additional relevant MeSH terms:
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Hormones, Hormone Substitutes, and Hormone Antagonists
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Pathologic Processes
Personality Disorders
Mental Disorders
Anxiety Disorders
Disruptive, Impulse Control, and Conduct Disorders
Physiological Effects of Drugs
Psychotropic Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action