Marinol in Trichotillomania or Obsessive Compulsive Disorder

• Status: Completed
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Chicago
• Treatments: Dronabinol

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)