Clinical trial NCT05796752: Behavioral Treatment and Memantine in Body Focused Repetitive Behaviors
Official title: Single-Group Crossover Trial Comparing Behavioral Treatment to Memantine in Body Focused Repetitive Behaviors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Skin-Picking
Trichotillomania (Hair-Pulling Disorder)
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2023-04-03
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Hair pulling disorder (i.e., trichotillomania, TTM) and skin picking disorder (SPD) are often categorized under the umbrella term of BFRB disorders. These repetitive, intentionally performed behaviors often cause noticeable cosmetic issues and may result in clinically significant distress or functional impairment.

Behavioral therapy (BT) is generally regarded as the first-line treatment for BFRBs. One type of BT is comprehensive behavioral treatment (ComB), a treatment that emphasizes habit reversal training and various techniques that target specific BFRB triggers (e.g., sensory cues, such as pressure on the scalp; environmental cues, such as bright lights and mirrors), including emotion dysregulation. The ComB protocol was methodically developed based on expert consensus and demonstrated promising results in one single case design study and a randomized controlled trial comparing it to a minimal attention control condition.

Research has also found benefit of pharmacological agents in the treatment of BFRBs. Most recently, a randomized controlled trial of memantine vs. placebo found statistically significant improvements in disorder severity and life functioning in the memantine group as compared to the placebo group.

Although there are emerging behavioral and psychopharmacological interventions for BFRBs, the research is limited. Additionally, there are no studies comparing the efficacy of first-line behavioral treatments to promising medication interventions for this class of disorders. Given the serious personal consequences associated with trichotillomania and skin picking disorder, there is substantial need for additional research to clarify the best available treatments for BFRBs. Doing so would facilitate future research and the development of refined treatment guidelines. Therefore, the current trial aims to compare the efficacy of behavioral therapy and memantine in adults with trichotillomania and skin picking disorder.

Eligibility criteria: 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

Primary outcomes:
measure: National Institutes of Mental Health Symptom Severity Scale (for trichotillomania or Skin Picking) (NIMH-TSS or NIMH-SPS)
timeFrame: The primary efficacy endpoints will be the change in these measures from baseline to week 8 in memantine treatment vs. ComB treatment.
Secondary outcomes:
measure: Clinical Global Impressions -- Improvement Scale (CGI-I)
timeFrame: 20 weeks
measure: Massachusetts General Hospital Hairpulling Scale (MGH-HPS)
timeFrame: 20 weeks
measure: Massachusetts General Hospital Hairpulling Scale -- Revised for Skin Picking
timeFrame: 20 weeks
measure: Quality of Life Inventory
timeFrame: 20 weeks
measure: Sheehan Disability Scale (SDS)
timeFrame: 20 weeks
measure: Hamilton Anxiety Rating Scale (HAM-A)
timeFrame: 20 weeks
measure: Hamilton Depression Rating Scale (HAM-D)
timeFrame: 20 weeks
measure: Barratt Impulsiveness Scale (BIS)
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
Study officials:
affiliation: University of Chicago
name: Jon E Grant, MD, JD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chicago
name: Gregory Chasson, PhD
role: PRINCIPAL_INVESTIGATOR
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citation: Grant JE, Odlaug BL, Chamberlain SR, Keuthen NJ, Lochner C, Stein DJ. Skin picking disorder. Am J Psychiatry. 2012 Nov;169(11):1143-9. doi: 10.1176/appi.ajp.2012.12040508.
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