Marinol in Trichotillomania or Obsessive Compulsive Disorder

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Brief Title

Marinol in Trichotillomania or Obsessive Compulsive Disorder

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

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.
    

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 Phase

Phase 2

Study Type

Interventional


Primary Outcome

Massachusetts General Hospital Hairpulling Scale (MGH-HPS) Total Score


Condition

Trichotillomania

Intervention

Dronabinol

Study Arms / Comparison Groups

 Dronabinol
Description:  Dronabinol (Marinol) - 2.5mg-15mg by mouth once a day for twelve-weeks

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

14

Start Date

April 2010

Completion Date

February 2011

Primary Completion Date

January 2011

Eligibility 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)
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Jon E Grant, JD, MD, MPH, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01093976

Organization ID

0909M72088


Responsible Party

Principal Investigator

Study Sponsor

University of Chicago


Study Sponsor

Jon E Grant, JD, MD, MPH, Principal Investigator, University of Minnesota


Verification Date

August 2013