Dronabinol in Trichotillomania and Other Body Focused Repetitive Behaviors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03530800|
Recruitment Status : Recruiting
First Posted : May 21, 2018
Last Update Posted : July 21, 2021
|Condition or disease||Intervention/treatment||Phase|
|Trichotillomania Skin-Picking||Drug: Dronabinol Drug: Placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
|Actual Primary Completion Date :||July 20, 2021|
|Estimated Study Completion Date :||August 1, 2021|
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.
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.
Placebo for 10 weeks
- 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.
- 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.
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
|Contact: Stephanie Valle, BAfirstname.lastname@example.org|
|Contact: Eve K Chesivoir, BAemail@example.com|
|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|
|Principal Investigator:||Jon E Grant, JD, MD, MPH||University of Chicago|