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Skin-PickingPhase 2/3NCT05796752

Behavioral Treatment and Memantine in Body Focused Repetitive Behaviors

A Phase 2/3 study testing Memantine and ComB Behavioral Therapy in people with Skin-Picking and Trichotillomania (Hair-Pulling Disorder), run by University of Chicago at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Memantine and ComB Behavioral Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteUnited States
Study dates
2 Aug 2023to Jun 2027
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Chicago Medical Center

    Chicago, Illinois, 60637

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Memantine, ComB Behavioral Therapy
Medical subject headings
Excoriation Disorder, Trichotillomania

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MemantineDrug

    Also called Namenda

    Cognition-enhancing medication

  • ComB Behavioral TherapyBehavioural

    Therapy for BFRBs

Study groups in NCT05796752
Study groupRoleWhat they receive
Memantine and Behavioral TherapyExperimentalAll 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.
Receives: Drug: Memantine; Behavioral: ComB Behavioral Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (7)
  1. 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.

    Measured: 20 weeks

  2. 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.

    Measured: 20 weeks

  3. 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.

    Measured: 20 weeks

  4. 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.

    Measured: 20 weeks

  5. 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.

    Measured: 20 weeks

  6. 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.

    Measured: 20 weeks

  7. 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.

    Measured: 20 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2023
  2. Study start2 Aug 2023
  3. Primary completion16 Apr 2026
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05796752
Sponsor's protocol ID
IRB23-0033
Status last verified
Jul 2026
First submitted
22 Mar 2023
Last updated
7 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

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

    PubMed 27581696
  • 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.

    PubMed 17194265
  • 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.

    PubMed 23128921
  • 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.

    PubMed 32390221
  • 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.

    PubMed 26643276
  • 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.

    PubMed 32587552
  • 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.

    PubMed 34656205
  • 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.

    PubMed 2761586
  • 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.

    PubMed 8657844
  • 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.

    PubMed 14399272
  • 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.

    PubMed 13638508
  • 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.

    PubMed 8778124

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Memantine and ComB Behavioral Therapy in people with Skin-Picking and Trichotillomania (Hair-Pulling Disorder), run by University of Chicago at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

National Institutes of Mental Health Symptom Severity Scale (for trichotillomania or Skin Picking) (NIMH-TSS or NIMH-SPS) (time frame: The primary efficacy endpoints will be the change in these measures from baseline to week 8 in memantine treatment vs. ComB treatment.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05796752, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.

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Clinical Trial NCT05796752 | AzTrials