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Dronabinol in Trichotillomania and Other Body Focused Repetitive Behaviors

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ClinicalTrials.gov Identifier: NCT03530800
Recruitment Status : Recruiting
First Posted : May 21, 2018
Last Update Posted : March 25, 2019
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Brief Summary:
The goal of the proposed study is to evaluate the efficacy and safety of dronabinol in trichotillomania and other body-focused repetitive behaviors such as skin-picking disorder. 50 subjects with DSM-5 trichotillomania or skin-picking disorder will receive 10 weeks of double-blind dronabinol or placebo. The hypothesis to be tested is that dronabinol will be effective and well tolerated in patients with trichotillomania and/or skin-picking disorder compared to placebo. The proposed study will provide needed data on the treatment of disabling disorders that currently lacks a clearly effective treatment.

Condition or disease Intervention/treatment Phase
Trichotillomania Skin-Picking Drug: Dronabinol Drug: Placebo Phase 2 Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled Study of Dronabinol in Trichotillomania and Other Body Focused Repetitive Behaviors
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Dronabinol

Arm Intervention/treatment
Active Comparator: Dronabinol
Subjects will receive dronabinol 5mg once daily for two weeks, 5mg twice daily for the subsequent two weeks, and 5mg three times daily for the final six weeks. Dose escalations will only be done if the investigator deems necessary.
Drug: Dronabinol
Dronabinol for 10 weeks (5mg per day first 2 weeks, 10mg per day second two weeks, 15mg per day last six weeks)
Other Name: Marinol

Placebo Comparator: Placebo
Subjects will receive placebo for 10 weeks weeks.
Drug: Placebo
Placebo for 10 weeks




Primary Outcome Measures :
  1. NIMH Trichotillomania Symptom Severity Scale (NIMH-TSS) [ Time Frame: Up to 10 weeks ]
    The entire study lasts 10 weeks. Every two weeks subjects will take the NIMH-TSS. The change in scores from baseline to after 10 weeks will be assessed. The scale itself assesses severity of trichotillomania symptoms. The NIMH-TSS score ranges from 0 to 20, with 0 being no symptoms and 20 being the most severe.

  2. Skin Picking Symptom Assessment Scale (SP-SAS) [ Time Frame: Up to 10 weeks ]
    The entire study lasts 10 weeks. Every two weeks subjects will take the SP-SAS. The change in scores from baseline to after 10 weeks will be assessed. The scale itself assesses severity of skin-picking symptoms. The SP-SAS score ranges from 0 to 48, with 0 being no symptoms and 48 being the most severe.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • current DSM-5 trichotillomania
  • ability to understand and sign the consent form

Exclusion Criteria:

  • Unstable Medical illness based on history of clinically significant abnormalities on baseline physical examination
  • Current pregnancy or lactation, or inadequate contraception in women of childbearing potential
  • Subjects considered an immediate suicide risk based on the Columbia Suicide Severity Rating Scale (C-SSRS) (www.cssrs.columbia.edu/docs)
  • Past 12-month DSM-5 psychiatric disorder other than trichotillomania
  • Illegal substance use based on urine toxicology screening
  • Use of any other psychotropic medication (except a PRN hypnotic)
  • Previous treatment with dronabinol
  • Cognitive impairment that interferes with the capacity to understand and self administer medication or provide written informed consent

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 ClinicalTrials.gov identifier (NCT number): NCT03530800


Contacts
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Contact: Stephanie Valle, BA 773-834-3778 svalle@yoda.bsd.uchicago.edu
Contact: Elizabeth Cavic, BS 773-702-9066 ec642@bsd.uchicago.edu

Locations
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United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Jon E Grant, JD, MD, MPH    773-702-9066      
Principal Investigator: Jon E Grant, JD, MD, MPH         
Sponsors and Collaborators
University of Chicago
Investigators
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Principal Investigator: Jon E Grant, JD, MD, MPH University of Chicago

Publications:

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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT03530800     History of Changes
Other Study ID Numbers: 18-0542
First Posted: May 21, 2018    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to share individual participant data.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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