Behavioral Treatment and Memantine in Body Focused Repetitive Behaviors

NCT05796752 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: IRB23-0033
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin-Picking; Trichotillomania (Hair-Pulling Disorder)

Outcome Measures

Primary Outcomes (1)

• National Institutes of Mental Health Symptom Severity Scale (for trichotillomania or Skin Picking) (NIMH-TSS or NIMH-SPS)

  The primary efficacy measure will be the change in hair pulling or skin picking frequency and urges to pull hair or pick skin for the past week as indicated by change in total score on the NIMH Symptom Severity Scale (for Trichotillomania or Skin Picking). The primary endpoints will be used to examine differential improvements for memantine vs. BT. Total scores on the NIMH-TSS and NIMH-SPS range from 0-20, with higher scores representing greater severity of trichotillomania/skin picking.

  The primary efficacy endpoints will be the change in these measures from baseline to week 8 in memantine treatment vs. ComB treatment.

Secondary Outcomes (8)

• Clinical Global Impressions -- Improvement Scale (CGI-I)

  20 weeks

• Massachusetts General Hospital Hairpulling Scale (MGH-HPS)

  20 weeks

• Massachusetts General Hospital Hairpulling Scale -- Revised for Skin Picking

  20 weeks

• Quality of Life Inventory

  20 weeks

• Sheehan Disability Scale (SDS)

  20 weeks

Study Arms (1)

Memantine and Behavioral Therapy

EXPERIMENTAL

All subjects will receive 8-weeks of memantine treatment (10mg po qday for the first two weeks, then 20 mg po qday for the remaining six weeks). After the 8-weeks of memantine treatment, the dose will be discontinued. Then, after a 4-week washout period, all subjects will receive 8-weeks of ComB therapy. Therapy will be once a week for 30 minutes. After the 8-weeks of ComB treatment, the therapy will be discontinued.

Drug: Memantine; Behavioral: ComB Behavioral Therapy

Interventions

Memantine DRUG

Cognition-enhancing medication

Also known as: Namenda

Memantine and Behavioral Therapy

ComB Behavioral Therapy BEHAVIORAL

Therapy for BFRBs

Memantine and Behavioral Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Related Publications (12)

• Grant JE, Chamberlain SR. Trichotillomania. Am J Psychiatry. 2016 Sep 1;173(9):868-74. doi: 10.1176/appi.ajp.2016.15111432.

  PMID: 27581696 BACKGROUND

• Woods DW, Flessner CA, Franklin ME, Keuthen NJ, Goodwin RD, Stein DJ, Walther MR; Trichotillomania Learning Center-Scientific Advisory Board. The Trichotillomania Impact Project (TIP): exploring phenomenology, functional impairment, and treatment utilization. J Clin Psychiatry. 2006 Dec;67(12):1877-88. doi: 10.4088/jcp.v67n1207.

  PMID: 17194265 BACKGROUND

• 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.

  PMID: 23128921 BACKGROUND

• Farhat LC, Olfson E, Nasir M, Levine JLS, Li F, Miguel EC, Bloch MH. Pharmacological and behavioral treatment for trichotillomania: An updated systematic review with meta-analysis. Depress Anxiety. 2020 Aug;37(8):715-727. doi: 10.1002/da.23028. Epub 2020 May 10.

  PMID: 32390221 BACKGROUND

• Falkenstein MJ, Mouton-Odum S, Mansueto CS, Golomb RG, Haaga DA. Comprehensive Behavioral Treatment of Trichotillomania: A Treatment Development Study. Behav Modif. 2016 May;40(3):414-38. doi: 10.1177/0145445515616369. Epub 2015 Dec 7.

  PMID: 26643276 BACKGROUND

• Bottesi G, Ouimet AJ, Cerea S, Granziol U, Carraro E, Sica C, Ghisi M. Comprehensive Behavioral Therapy of Trichotillomania: A Multiple-Baseline Single-Case Experimental Design. Front Psychol. 2020 Jun 10;11:1210. doi: 10.3389/fpsyg.2020.01210. eCollection 2020.

  PMID: 32587552 BACKGROUND

• Carlson EJ, Malloy EJ, Brauer L, Golomb RG, Grant JE, Mansueto CS, Haaga DAF. Comprehensive Behavioral (ComB) Treatment of Trichotillomania: A Randomized Clinical Trial. Behav Ther. 2021 Nov;52(6):1543-1557. doi: 10.1016/j.beth.2021.05.007. Epub 2021 Jun 3.

  PMID: 34656205 BACKGROUND

• Swedo SE, Leonard HL, Rapoport JL, Lenane MC, Goldberger EL, Cheslow DL. A double-blind comparison of clomipramine and desipramine in the treatment of trichotillomania (hair pulling). N Engl J Med. 1989 Aug 24;321(8):497-501. doi: 10.1056/NEJM198908243210803.

  PMID: 2761586 BACKGROUND

• Keuthen NJ, O'Sullivan RL, Ricciardi JN, Shera D, Savage CR, Borgmann AS, Jenike MA, Baer L. The Massachusetts General Hospital (MGH) Hairpulling Scale: 1. development and factor analyses. Psychother Psychosom. 1995;64(3-4):141-5. doi: 10.1159/000289003.

  PMID: 8657844 BACKGROUND

• HAMILTON M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960 Feb;23(1):56-62. doi: 10.1136/jnnp.23.1.56. No abstract available.

  PMID: 14399272 BACKGROUND

• HAMILTON M. The assessment of anxiety states by rating. Br J Med Psychol. 1959;32(1):50-5. doi: 10.1111/j.2044-8341.1959.tb00467.x. No abstract available.

  PMID: 13638508 BACKGROUND

• Patton JH, Stanford MS, Barratt ES. Factor structure of the Barratt impulsiveness scale. J Clin Psychol. 1995 Nov;51(6):768-74. doi: 10.1002/1097-4679(199511)51:63.0.co;2-1.

  PMID: 8778124 BACKGROUND

MeSH Terms

Conditions

Excoriation Disorder; Trichotillomania

Interventions

Memantine

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior; Obsessive-Compulsive Disorder; Anxiety Disorders; Mental Disorders; Disruptive, Impulse Control, and Conduct Disorders

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Jon E Grant, MD, JD, MPH

  University of Chicago

  PRINCIPAL INVESTIGATOR

• Gregory Chasson, PhD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: April 3, 2023
• Study Start: August 2, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-09

Locations

US (1)