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Marinol in Trichotillomania or Obsessive Compulsive Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jon Grant, University of Chicago
ClinicalTrials.gov Identifier:
NCT01093976
First received: March 24, 2010
Last updated: August 6, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Trichotillomania
Obsessive Compulsive Disorder
Drug: Dronabinol
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Massachusetts General Hospital Hairpulling Scale (MGH-HPS) Total Score [ Time Frame: Subjects were followed for their duration of participation in the study (12-weeks) ] [ Designated as safety issue: No ]
    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.


Enrollment: 14
Study Start Date: April 2010
Study Completion Date: February 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01093976

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

Additional Information:
No publications provided by University of Chicago

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jon Grant, Professor of Psychiatry, University of Chicago
ClinicalTrials.gov Identifier: NCT01093976     History of Changes
Other Study ID Numbers: 0909M72088
Study First Received: March 24, 2010
Results First Received: March 1, 2012
Last Updated: August 6, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
Skin Picking
OCD
Trichotillomania
Pathological Skin Picking

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

ClinicalTrials.gov processed this record on November 27, 2014