Behavioral Treatment and Memantine in Body Focused Repetitive Behaviors

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The goal of the proposed study is to compare the efficacy of behavioral treatment (BT) to memantine, a psychopharmacological agent, for BFRBs. 28 subjects with trichotillomania (TTM) or skin picking disorder (SPD) will receive 8 weeks of memantine treatment, followed by 8 weeks of comprehensive behavioral therapy (ComB) treatment. The hypothesis to be tested is that behavioral therapy will be associated with superior clinical outcomes as compared to memantine. A second hypothesis is that both memantine and behavioral therapy will demonstrate improvement from baseline to the respective posttreatment assessment.

Conditions:

🦠 Skin-Picking 🦠 Trichotillomania (Hair-Pulling Disorder)

🗓️ Study Start (Actual) 2 August 2023

🗓️ Primary Completion (Estimated) 1 December 2024

✅ Study Completion (Estimated) 1 December 2024

👥 Enrollment (Estimated) 28

🔬 Study Type INTERVENTIONAL

📊 Phase PHASE2

Locations:

📍 Chicago, Illinois, United States

📋 Eligibility Criteria

Description

Inclusion Criteria:

* Men and women ages 18+
* Current DSM-5 diagnosis of trichotillomania (TTM) or skin picking disorder (SPD)
* Ability to understand and sign the consent form
* Stable dose of medications for at least the past 3 months

Exclusion Criteria:

* Unstable medical illness based on history or 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)
* Past 12-month DSM-5 diagnosis of psychosis, bipolar disorder, mania, or a substance or alcohol use disorder
* Illegal substance use based on urine toxicology screening
* Previous treatment with memantine
* Previous trial of ComB or similar BT protocol (e,g., habit reversal training)
* Cognitive impairment that interferes with the capacity to understand and self-administer medication or provide written informed consent

Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 22 March 2023
First Submitted that Met QC Criteria 22 March 2023
First Posted 3 April 2023

Study Record Updates

Last Update Submitted that Met QC Criteria 23 July 2024
Last Update Posted 25 July 2024
Last Verified February 2024