Marinol in Trichotillomania or Obsessive Compulsive Disorder

NCT01093976 | Completed Phase 2 Results DMC

• 1 other identifier: 0909M72088
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Trichotillomania; Obsessive Compulsive Disorder

Keywords

Skin Picking; OCD; Trichotillomania; Pathological Skin Picking

Outcome Measures

Primary Outcomes (1)

• 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.

  Subjects were followed for their duration of participation in the study (12-weeks)

Study Arms (1)

Dronabinol

EXPERIMENTAL

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

Drug: Dronabinol

Interventions

Dronabinol DRUG

2.5mg-15mg by mouth once a day for twelve-weeks

Also known as: MARINOL

Dronabinol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

Ambulatory Research Center

Minneapolis, Minnesota, 55454, United States

Location

Related Publications (1)

• 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.

  PMID: 21590520 DERIVED

Related Links

• Impulse Control Disorders Clinic - University of Minnesota

MeSH Terms

Conditions

Trichotillomania; Obsessive-Compulsive Disorder; Excoriation Disorder

Interventions

Dronabinol

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Disruptive, Impulse Control, and Conduct Disorders; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Jon E. Grant
• Organization: University of Minnesota

grant045@umn.edu

612-273-9800

Study Officials

• Jon E Grant, JD, MD, MPH

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2010
• First Posted: March 26, 2010
• Study Start: April 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: February 1, 2011
• Last Updated: February 23, 2023
• Results First Posted: September 27, 2013

Record last verified: 2023-02

Locations

US (1)