Single-Group Crossover Trial Comparing Behavioral Treatment to Memantine in Body Focused Repetitive Behaviors

IRB23-0033

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.

2023-08-02

2024-06-01

2024-06-01

Recruiting

Early phase I

28

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 28, 'type': 'ESTIMATED'}}

2024-02-05