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Behavioral Treatment and Memantine in Body Focused Repetitive Behaviors

Primary Purpose

Skin-Picking, Trichotillomania (Hair-Pulling Disorder)

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Memantine
ComB Behavioral Therapy
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Skin-Picking

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Memantine and Behavioral Therapy

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Clinical Global Impressions -- Improvement Scale (CGI-I)
    A clinician-rated measure to assess global improvement in symptoms. The scale ranges from 1 (Very much improved) to 7 (Very much worse). The results will be dichotomized as improved (CGI-I score of 1 or 2) or not improved (CGI-I score of 3-7). The scale will be assessed at the end of the memantine treatment, at the end of the washout period, and at the end of the ComB therapy treatment.
    Massachusetts General Hospital Hairpulling Scale (MGH-HPS)
    Brief, self-report instrument for assessing repetitive hairpulling. Seven individual items, rated for severity from 0 to 4, assess urges to pull, actual pulling, perceived control, and associated distress. Total scores range from 0-28, with higher scores indicating greater severity of trichotillomania (TTM).The scale will be administered at screening, the end of the memantine treatment, at the end of the washout period, and at the end of the ComB therapy treatment.
    Massachusetts General Hospital Hairpulling Scale -- Revised for Skin Picking
    Brief, self-report instrument for assessing repetitive skin picking. Seven individual items, rated for severity from 0 to 4, assess urges to pick, actual picking, perceived control, and associated distress. Total scores range from 0-28, with higher scores indicating greater severity of skin picking disorder. The scale will be administered at screening, the end of the memantine treatment, at the end of the washout period, and at the end of the ComB therapy treatment.
    Quality of Life Inventory
    A self-report assessment of patient perceived quality of life. Quality of Life Inventory t-scores range from 1-77. Higher scores indicate a higher quality of life, whereas lower scores indicate a lower quality of life. The scale will be administered at screening, the end of the memantine treatment, at the end of the washout period, and at the end of the ComB therapy treatment.
    Sheehan Disability Scale (SDS)
    A self-report measure of functional impairment from TTM or SPD. SDS total scores range from 0-30. Higher scores indicate greater functional impairment. The scale will be administered at screening, the end of the memantine treatment, at the end of the washout period, and at the end of the ComB therapy treatment.
    Hamilton Anxiety Rating Scale (HAM-A)
    A clinician-administered assessment of anxiety. HAM-A total scores range from 0-56. Higher scores indicate higher levels of anxiety, with 0 being no symptoms of anxiety. The scale will be administered at screening, the end of the memantine treatment, at the end of the washout period, and at the end of the ComB therapy treatment.
    Hamilton Depression Rating Scale (HAM-D)
    A clinician-administered assessment of depression. HAM-D total scores range from 0-52. Higher scores indicate higher levels of depression, with 0 being no symptoms of depression. The scale will be administered at screening, the end of the memantine treatment, at the end of the washout period, and at the end of the ComB therapy treatment.
    Barratt Impulsiveness Scale (BIS)
    A self-report assessment of impulsivity. BIS total scores range from 30-120. Higher total scores indicate higher impulsiveness. The scale will be administered at screening, the end of the memantine treatment, at the end of the washout period, and at the end of the ComB therapy treatment.

    Full Information

    First Posted
    March 22, 2023
    Last Updated
    May 11, 2023
    Sponsor
    University of Chicago
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05796752
    Brief Title
    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

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 1, 2023 (Anticipated)
    Primary Completion Date
    June 1, 2024 (Anticipated)
    Study Completion Date
    June 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Chicago

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Skin-Picking, Trichotillomania (Hair-Pulling Disorder)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    28 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Memantine and Behavioral Therapy
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    Memantine
    Other Intervention Name(s)
    Namenda
    Intervention Description
    Cognition-enhancing medication
    Intervention Type
    Behavioral
    Intervention Name(s)
    ComB Behavioral Therapy
    Intervention Description
    Therapy for BFRBs
    Primary Outcome Measure Information:
    Title
    National Institutes of Mental Health Symptom Severity Scale (for trichotillomania or Skin Picking) (NIMH-TSS or NIMH-SPS)
    Description
    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.
    Time Frame
    The primary efficacy endpoints will be the change in these measures from baseline to week 8 in memantine treatment vs. ComB treatment.
    Secondary Outcome Measure Information:
    Title
    Clinical Global Impressions -- Improvement Scale (CGI-I)
    Description
    A clinician-rated measure to assess global improvement in symptoms. The scale ranges from 1 (Very much improved) to 7 (Very much worse). The results will be dichotomized as improved (CGI-I score of 1 or 2) or not improved (CGI-I score of 3-7). The scale will be assessed at the end of the memantine treatment, at the end of the washout period, and at the end of the ComB therapy treatment.
    Time Frame
    20 weeks
    Title
    Massachusetts General Hospital Hairpulling Scale (MGH-HPS)
    Description
    Brief, self-report instrument for assessing repetitive hairpulling. Seven individual items, rated for severity from 0 to 4, assess urges to pull, actual pulling, perceived control, and associated distress. Total scores range from 0-28, with higher scores indicating greater severity of trichotillomania (TTM).The scale will be administered at screening, the end of the memantine treatment, at the end of the washout period, and at the end of the ComB therapy treatment.
    Time Frame
    20 weeks
    Title
    Massachusetts General Hospital Hairpulling Scale -- Revised for Skin Picking
    Description
    Brief, self-report instrument for assessing repetitive skin picking. Seven individual items, rated for severity from 0 to 4, assess urges to pick, actual picking, perceived control, and associated distress. Total scores range from 0-28, with higher scores indicating greater severity of skin picking disorder. The scale will be administered at screening, the end of the memantine treatment, at the end of the washout period, and at the end of the ComB therapy treatment.
    Time Frame
    20 weeks
    Title
    Quality of Life Inventory
    Description
    A self-report assessment of patient perceived quality of life. Quality of Life Inventory t-scores range from 1-77. Higher scores indicate a higher quality of life, whereas lower scores indicate a lower quality of life. The scale will be administered at screening, the end of the memantine treatment, at the end of the washout period, and at the end of the ComB therapy treatment.
    Time Frame
    20 weeks
    Title
    Sheehan Disability Scale (SDS)
    Description
    A self-report measure of functional impairment from TTM or SPD. SDS total scores range from 0-30. Higher scores indicate greater functional impairment. The scale will be administered at screening, the end of the memantine treatment, at the end of the washout period, and at the end of the ComB therapy treatment.
    Time Frame
    20 weeks
    Title
    Hamilton Anxiety Rating Scale (HAM-A)
    Description
    A clinician-administered assessment of anxiety. HAM-A total scores range from 0-56. Higher scores indicate higher levels of anxiety, with 0 being no symptoms of anxiety. The scale will be administered at screening, the end of the memantine treatment, at the end of the washout period, and at the end of the ComB therapy treatment.
    Time Frame
    20 weeks
    Title
    Hamilton Depression Rating Scale (HAM-D)
    Description
    A clinician-administered assessment of depression. HAM-D total scores range from 0-52. Higher scores indicate higher levels of depression, with 0 being no symptoms of depression. The scale will be administered at screening, the end of the memantine treatment, at the end of the washout period, and at the end of the ComB therapy treatment.
    Time Frame
    20 weeks
    Title
    Barratt Impulsiveness Scale (BIS)
    Description
    A self-report assessment of impulsivity. BIS total scores range from 30-120. Higher total scores indicate higher impulsiveness. The scale will be administered at screening, the end of the memantine treatment, at the end of the washout period, and at the end of the ComB therapy treatment.
    Time Frame
    20 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Madison Collins, BA
    Phone
    7738343778
    Email
    mcollins4@bsd.uchicago.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jon E Grant, MD, JD, MPH
    Organizational Affiliation
    University of Chicago
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Gregory Chasson, PhD
    Organizational Affiliation
    University of Chicago
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    27581696
    Citation
    Grant JE, Chamberlain SR. Trichotillomania. Am J Psychiatry. 2016 Sep 1;173(9):868-74. doi: 10.1176/appi.ajp.2016.15111432.
    Results Reference
    background
    PubMed Identifier
    17194265
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    23128921
    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.
    Results Reference
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    PubMed Identifier
    32390221
    Citation
    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.
    Results Reference
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    PubMed Identifier
    26643276
    Citation
    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.
    Results Reference
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    PubMed Identifier
    32587552
    Citation
    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.
    Results Reference
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    PubMed Identifier
    34656205
    Citation
    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.
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    Citation
    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.
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    PubMed Identifier
    8657844
    Citation
    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.
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